[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cardio-vascular-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cardio-vascular-disease":672},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,21,0,[8,51,91,119,150,199,222,253,274,297,323,369,409,436,466,487,513,555,596,626,659],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":30,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100644544","lifestyle-advice-in-cvd-100644544",false,"NCT07672054","Lifestyle Advice in CVD","Perspectives and Experience of Patients From Minority Ethic Communities on Advice Provided About Diet and Lifestyle Advice in Management of Their Cardiovascular Disease","Inclusion Criteria:\n\n* Patients over the age of 18 years with a personal history of minority ethnicity (non-white) and a diagnosis of cardiovascular disease\n\nExclusion Criteria:\n\n* Patients with a personal history of white ethnicity Patients without a history of cardiovascular disease","ALL","18 Years",{"count":19,"type":20},15,"ESTIMATED","OBSERVATIONAL","Individuals living in the UK who are from ethnic minority communities have a higher risk of heart disease and strokes than white individuals. This risk arises from the social determinants of health. These include lifestyle factors such as diet, physical activity and smoking. Improving these lifestyle factors in individuals is an essential part of reducing the chances of heart attacks and stroke. Patients may have diets and lifestyles arising from their cultural and religious backgrounds but receive advice which is not aligned to their own customs and experiences. Receiving advice which is not relevant to their own types of diet and lifestyle customs may create difficulties for patients in managing their heart and circulation health. Moreover, the dissonance between advice given and patient-specific relevance may lead to poorer adherence to the recommendations made to manage their condition. This can lead to poorer health outcomes for these patients. In addition, they may be advised to adopt diets and behaviours which are not appropriate to their cultures and may be also difficult to put into practice. This is important because lifestyle advice aligned to a patient's existing diet, behaviours and cultural beliefs leads to improved control of these health conditions. Learning to provide dietary and lifestyle advice relevant to individual patients needs is an important skill for the clinicians caring for them.",[24,25,26,27,28,29],"Cardio Vascular Disease","Dietary Change","Dietary Behaviors","Diet Habits","Experience","Ethnicity",[31,32,29,33,34,35,36,37],"Diet","Cardiovascular disease","Behavioural change","Modification","Healthcare experience","Healthcare access","Medical education","NOT_YET_RECRUITING","2026-06-22",{"date":41,"type":42},"2026-06-26","ACTUAL",{"date":44,"type":20},"2026-07-06",{"date":46,"type":20},"2027-01-31",{"name":48,"class":49},"University of Nottingham","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":71,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":50},"100641181","compare-vent-feasibility-pilot-study-100641181","NCT07656259","COMPARE-VENT Feasibility Pilot Study","COMPARE-VENT Feasibility Pilot Study: A Pragmatic Cluster Randomized Crossover Trial for Ventilation Strategies and Hemodynamic Impact in Critically Ill Patients With Cardiovascular Disease","Inclusion Criteria:\n\nEligible adults ≥ 18 years of age admitted to the cardiac ICU with need for invasive mechanical ventilation of expected duration \\>12 hours.\n\nPre-Specified Subgroups for exploratory outcomes:\n\n1. SCAI Stages C-E Cardiogenic Shock\n2. Mechanical circulatory support use, including intra-aortic balloon pumps and microaxial flow pumps, including Impella CP, RP Impella Flex, and Impella 5.5 devices\n3. Heart failure with reduced ejection fraction: LVEF \\\u003C40% or;\n4. Moderate to severe RV systolic dysfunction or;\n5. Moderate to severe Pulmonary hypertension, as defined by ACC\u002FAHA\u002FESC guidelines\n\nExclusion Criteria:\n\n1. Expected duration of intubation \\\u003C12 hours.\n2. Severe COPD, bronchopleural fistulas, or severe ARDS (Berlin criteria P\u002FF \\\u003C100, in the absence of pulmonary edema)\n3. Home ventilator or chronic tracheostomy.\n4. Pregnant, incarcerated, patients or those receiving extracorporeal membrane oxygenation",{"count":59,"type":20},75,"INTERVENTIONAL",[62],"NA","Cardiac disease complicated by respiratory insufficiency comprises the most frequent indication for cardiac intensive care unit (CICU) admission, with nearly one-third patients requiring advanced respiratory support and over 20% patients requiring invasive mechanical ventilation (IMV). IMV among patients with impaired cardiovascular reserve is further compounded by the adverse impact of positive pressure ventilation (PPV) and systemic sedation on intracardiac hemodynamics, pulmonary vascular mechanics and consequently end-organ perfusion. Despite widespread use, evidence guiding optimal ventilatory practices and mode selection in cardiovascular intensive care unit patients remains limited. Pressure-controlled and volume-controlled ventilation may differ in their effects on patient-ventilator synchrony, sedation requirements, and hemodynamic impact, but comparative data among patients with critical cardiac disease remains inconclusive. This pilot study will evaluate the feasibility of implementing a pragmatic cluster-randomized crossover trial comparing ventilatory modes in a contemporary cardiovascular intensive care unit.",[65,24,66,67,68,69,70],"Respiration Failure","Cardiogenic Pulmonary Oedema","Critical Illness","Mechanical Ventilation","Cardiogenic Shock","Cardiopulmonary",[32,72,73,74,75,76,77,78,79,80,81],"Cardiac arrest","Cardiogenic shock","Respiratory failure","Cardiopulmonary interactions","Critical illness","Intensive care unit","Critical care therapies","Outcomes","Mechanical ventilation","Positive pressure ventilation","2026-06-14",{"date":84,"type":42},"2026-06-18",{"date":86,"type":20},"2026-07-01",{"date":88,"type":20},"2027-06-30",{"name":90,"class":49},"Mayo Clinic",{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":4,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":16,"minAge":98,"maxAge":4,"enrollmentInfo":99,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":101,"conditions":102,"keywords":103,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":50},"100643408","an-study-looking-at-percutaneous-coronary-intervention-outcomes-for-octogenarians-100643408","NCT07633964","An Study Looking at Percutaneous Coronary Intervention Outcomes for Octogenarians","An Observational Study Looking at the Demographics and Outcomes of Octogenarians Undergoing Percutaneous Coronary Intervention (PCI) Over a Seven-year Period at a Primary Percutaneous Coronary Intervention (PPCI) Centre With Off-site Cardiothoracic Support","Inclusion Criteria:\n\n* Participants who had PCI at our hospital trust between 1st January 2017 - 31st December 2023.\n\nExclusion Criteria:\n\n* Participants with negative pressure wire studies (i.e. the lesion identified was not flow restricting).\n* Participants had \"failed PCI\".\n* Participants with significantly incomplete data despite thorough review of the electronic records.","80 Years",{"count":100,"type":20},850,"The goal of this observational study is to understand the makeup of the participants aged 80 years and older who had stents fitted or balloon expansion of their heart arteries, otherwise known as percutaneous coronary intervention (PCI), at our hospital over a seven year period. The investigators will aim to describe the cohort with respect to their health conditions, age and frailty in addition to whether their procedure was planned or an emergency. The investigators will also look at the outcomes of these participants up to one year post procedure. The secondary aim is to look for associations between participant variables and their outcomes in hospital and at 1 year. The specific outcomes the investigators will look at are: inpatient complications and the incidence of heart attacks, strokes, unplanned PCI, cardiac rehospitalisation or death.",[24],[104,105,106,107,108,109],"cardiovascular","octogenarian","frailty","SYNTAX","Percutaneous Coronary Intervention","calcification severity","2026-06-03",{"date":112,"type":42},"2026-06-08",{"date":114,"type":20},"2026-06",{"date":116,"type":20},"2027-06",{"name":118,"class":49},"Gloucestershire Hospitals NHS Foundation Trust",{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":125,"eligibilityCriteria":126,"healthyVolunteers":127,"sex":16,"minAge":17,"maxAge":128,"enrollmentInfo":129,"targetDuration":4,"studyType":60,"phases":131,"briefSummary":132,"conditions":133,"keywords":139,"overallStatus":141,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":50},"100638376","support-your-heart-phase-1-100638376","NCT07623733","Support Your Heart, Phase 1","Support Your Heart: Feasibility Trial of a Cardiovascular Health Intervention for Young Adults, Phase 1","SYH","Inclusion Criteria:\n\n1. 18-39 at time of enrollment\n2. Living in Washington DC area\n3. At least two risk factors for cardiovascular disease:\n\n   1. not enough sleep\n   2. insufficient physical activity\n   3. tobacco and nicotine product use\n   4. elevated body mass index\n   5. poor diet\n   6. high cholesterol\n   7. high blood pressure; and\u002For\n   8. elevated HbA1c.\n\nExclusion Criteria:\n\n* 1\\. Major medical condition or chronic disease that would impede physical activity or increase the risk of the intervention (e.g., reported type 1 or type 2 diabetes, cerebrovascular accident, systolic blood pressure \\>180 mmHg or diastolic blood pressure \\>105 mmHg, renal disease, pulmonary disease dependent on oxygen, recent orthopedic injury, significant surgery within the last 6 months, HbA1c \\>6.5%, total cholesterol \\>240 mg\u002FdL); 2. Plan to become pregnant during study duration; 3. Psychiatric hospitalization, psychosis or suicide attempt within the last 12 months; 4. Alcohol or substance use disorder; 5. An eating disorder; 6. Conditions or behaviors that are likely to interfere with the conduct of the trial (e.g., inability to communicate with study staff, unwillingness to accept any of the three treatment assignments by randomization, current participation in another physical activity or lifestyle intervention research program)",true,"39 Years",{"count":130,"type":20},20,[62],"This is a pilot feasibility study designed to establish the feasibility and acceptability of the \"Support Your Heart\" (SYH) study's phone-based protocols regarding AHA's LE8, social isolation, loneliness, and stress.\n\nThe age range for this intervention is 18-39, which is intended to reflect the transitional life period from adolescence to adulthood. Participants must also display at least two LE8 risk factors for cardiovascular disease (e.g., not enough sleep or physical activity; tobacco\u002Fnicotine product use; elevated body mass index; high cholesterol, high blood pressure, elevated HbA1c , and\u002For poor diet).\n\nParticipants will receive weekly calls (averaging around 20-30 minutes each) from a SYH health coach in order to review key concepts, give personalized progress, and provide consistent feedback over the course of 12 weeks. SYH staff will measure improvement in AHA metrics as well as participant burden, acceptability, satisfaction, adherence, and retention. This research has the potential to create substantial public health impact by addressing cardiovascular health, social isolation, loneliness, and stress, all of which represent significant burdens to individual health.",[24,134,135,136,137,138],"Obesity & Overweight","Physical Activity","Sleep","Diet, Healthy","Nicotine",[140],"Life's Essential 8","RECRUITING","2026-05-28",{"date":110,"type":42},{"date":145,"type":20},"2026-06-01",{"date":147,"type":20},"2026-10-01",{"name":149,"class":49},"George Washington University",{"id":151,"slug":152,"hasResults":11,"nctId":153,"briefTitle":154,"officialTitle":154,"acronym":155,"eligibilityCriteria":156,"healthyVolunteers":127,"sex":157,"minAge":158,"maxAge":159,"enrollmentInfo":160,"targetDuration":4,"studyType":60,"phases":162,"briefSummary":163,"conditions":164,"keywords":171,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":50},"100639704","algal-lutein-against-decline-of-intellectual-nimbleness-100639704","NCT07600567","Algal Lutein Against Decline of Intellectual Nimbleness","ALADIN","Inclusion Criteria:\n\n* Females\n* Age 48-60 years\n* Postmenopausal status (natural menopause, up to 5 years after menopause)\n* waist circumference ≥ 88 cm\n\nExclusion Criteria:\n\n* Diagnosis of dementia or cognitive impairment\n* Use of hormone replacement therapy within the last 6 months\n* Advanced age-related macular degeneration\n* History of major untreated neurological or psychiatric disorders (including depression, Parkinson's disease, Alzheimer's disease, psychiatric disorders, stroke within the last 3 months)\n* Presence of chronic diseases, including: diabetes mellitus (type 1 or 2), lipid disorders, cardiovascular diseases, thyroid diseases, anemia, liver diseases, gastrointestinal disorders, or cancer within the last 5 years\n* Use of anti-inflammatory medications or medications targeting lipid or carbohydrate metabolism within the last 3 months\n* Alcohol consumption \\> 100 g per week\n* Use of lutein-containing supplements","FEMALE","48 Years","60 Years",{"count":161,"type":20},300,[62],"Lutein is a xanthophyll pigment found in photosynthesizing organisms. Its beneficial effects on health, including brain function and visual performance, have been recognized for many years. However, to date, only a limited number of well-designed human intervention studies have been published regarding the effects of incorporating lutein into the daily diet (as humans are unable to synthesize lutein endogenously). Unfortunately, within the Western dietary pattern, the average daily intake of lutein is approximately 1.7 mg, whereas achieving health benefits- such as reducing the risk of age-related macular degeneration and cataract, as well as neurodegenerative diseases- requires an intake of 6 to 14 mg per day.\n\nIn light of the above, it is therefore justified to enrich the daily diet with products that are sources of lutein. Unfortunately, the consumption of dark green vegetables- the richest dietary source of lutein-remains insufficient. Lutein preparations currently available on the market are extracted from marigold or calendula flowers. However, lutein production from these raw materials requires greater water consumption and land use, which is not aligned with the principles of sustainable development. An alternative approach involves the production of lutein preparations from microalgae (from species approved as food by the European Food Safety Authority, EFSA), as the rate of lutein production from microalgae is three to six times higher than that from marigold flowers.\n\nTaking the above into account, the primary objective of this project is to evaluate the dose-response relationship in establishing the anti-aging mechanism of action of lutein derived from microalgae.\n\nAs part of the project, a six-month randomized, placebo-controlled trial is planned. The study will include 300 polish women (aged 48-60 years), after natural menopause, with visceral obesity (waist circumference ≥ 88 cm). In order to enable the inclusion of such a large study population, the research team will conduct intensified recruitment efforts for several months prior to the initiation of the dietary intervention.\n\nParticipants who meet the inclusion criteria will be randomly assigned to one of three groups: lutein supplementation at a dose of 6 mg (n = 100), lutein supplementation at a dose of 14 mg (n = 100), or placebo (n = 100). The volunteers will be instructed to take the prescribed preparation daily for 180 days. All preparations will be identical in appearance, taste, and smell.\n\nAll volunteers expressing willingness to participate in the experiment will be asked to provide written informed consent prior to enrollment in the study.\n\nThe study will be conducted in accordance with the previously calculated sample size (n = 300 postmenopausal women with visceral obesity). In order to obtain a homogeneous study population, appropriate inclusion and exclusion criteria will be applied.\n\nConducting the research in such a large and homogeneous group will enable the generation of high-quality scientific evidence identifying the dose of microalgae-derived lutein that allows for the determination of its anti-aging mechanism of action. It will also be possible to elucidate the potential role of short-chain fatty acids (SCFAs) in feces in this process, which may represent a significant novelty in this field of research.\n\nThe study will contribute to the development of new knowledge regarding the anti-aging properties of lutein derived from microalgae in populations vulnerable to cognitive impairment (postmenopausal women). However, microalgae-derived lutein may be used as a dietary supplement not only in the studied group but also in the general population.\n\nThe specific objectives are as follows:\n\n* To assess the effect of lutein derived from microalgae (at doses of 6 mg and 14 mg) on the concentration of brain-derived neurotrophic factor (BDNF), inflammatory markers, cardiometabolic parameters, fecal short-chain fatty acid (SCFA) concentrations, and cognitive function in postmenopausal women with visceral obesity.\n* To evaluate adherence to lutein supplementation recommendations (by assessing macular pigment optical density).\n* To determine whether supplementation with microalgal lutein increases fecal SCFA concentrations and whether SCFAs may act as mediators in improving inflammatory markers and cognitive function in postmenopausal women with visceral obesity.\n* To determine whether supplementation with microalgal lutein (at doses of 6 mg and 14 mg) affects changes in selected gut bacterial populations and β-glucuronidase enzymatic activity in postmenopausal women with visceral obesity.\n* To analyse the association between polymorphisms in genes related to lutein metabolism and transport in the body and the effectiveness of supplementation with this compound.\n* To identify dietary behaviour patterns associated with high exposure to bisphenol A (BPA) and the presence of inflammation in postmenopausal women with visceral obesity.",[165,166,134,167,168,169,170,24],"Menopausal Syndrome","Cognitive Decline","Menopause","Inflamation","Gut Dysbiosis","Bisphenol A",[172,173,174,175,176,177,178,179,180,181,182,183,184,185,186,187,188,189],"menopausal syndrome","cognitive decline","obesity","menopause","inflammation","dysbiosis","bisphenol A","gut microbiota","BNDF","intellectual nimbleness","beta-glucuronidase","lutein","supplementation","micro-algae","gene polimorfism","eye vision","chlorella","sustainable development","2026-05-13",{"date":192,"type":42},"2026-05-20",{"date":194,"type":20},"2026-05-01",{"date":196,"type":20},"2027-04-30",{"name":198,"class":49},"Poznan University of Life Sciences",{"id":200,"slug":201,"hasResults":11,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":4,"eligibilityCriteria":205,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":98,"enrollmentInfo":206,"targetDuration":4,"studyType":60,"phases":208,"briefSummary":209,"conditions":210,"keywords":212,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":50},"100637397","perioperative-vericiguat-in-patients-undergoing-cardiovascular-surgery-100637397","NCT07594509","Perioperative Vericiguat in Patients Undergoing Cardiovascular Surgery","A Multicenter, Randomized, Controlled Trial to Evaluate the Efficacy and Safety of Perioperative Vericiguat in Patients Undergoing Cardiovascular Surgery","Inclusion Criteria:\n\n* Aged 18 to 80 years, any sex;\n* Scheduled to undergo cardiovascular surgery at the study centers, including coronary artery bypass grafting (CABG), heart valve replacement\u002Frepair, and great vessel surgery;\n* Preoperative evaluation indicates a high risk of heart failure or confirmed cardiac dysfunction;\n* Systolic blood pressure (SBP) \\>= 100 mmHg;\n* Expected to complete the 6-month postoperative follow-up;\n* Signed written informed consent by the patient or their authorized representative.\n\nExclusion Criteria:\n\n* Current use of other sGC stimulators or phosphodiesterase type 5 (PDE-5) inhibitors (e.g., sildenafil, tadalafil);\n* Severe hypotension (symptomatic hypotension or resting SBP \\\u003C 90 mmHg);\n* Severe hepatic or renal dysfunction (Hepatic: Child-Pugh class C, or ALT\u002FAST \\> 3 times the upper limit of normal; Renal: eGFR \\\u003C 15 mL\u002Fmin\u002F1.73m\\^2, or requiring chronic dialysis);\n* Malignant tumors, severe hematological diseases, or severe malnutrition (albumin \\\u003C 25 g\u002FL);\n* Known allergy to vericiguat or placebo components;\n* Pregnant or lactating women, or those planning to become pregnant during the study period;\n* Currently participating in other interventional clinical trials;\n* Moderate to severe cognitive impairment without a fixed guardian, unable to cooperate with treatment and follow-up;\n* Confirmed severe infection, sepsis, or septic shock preoperatively.",{"count":207,"type":20},600,[62],"The purpose of this study is to evaluate the efficacy and safety of perioperative vericiguat in patients undergoing cardiovascular surgery. Patients at high risk of heart failure or with confirmed cardiac dysfunction will be randomly assigned to receive either vericiguat plus standard of care or standard of care alone. The primary objective is to determine whether perioperative administration of vericiguat can reduce (I) the Incidence of Early Postoperative Hemodynamic Deterioration or Clinically Significant Myocardial Injury; (II) Incidence of Major Sterile Inflammation-Related Organ Injuries (MSIRI), and the incidence of Major Adverse Cardiovascular Events (MACE) within 12 months after surgery.",[24,211],"Cardiopulmonary Bypass",[104],"2026-05-11",{"date":215,"type":42},"2026-05-18",{"date":217,"type":20},"2026-05-31",{"date":219,"type":20},"2030-12-31",{"name":221,"class":49},"Nanjing Medical University",{"id":223,"slug":224,"hasResults":11,"nctId":225,"briefTitle":226,"officialTitle":227,"acronym":4,"eligibilityCriteria":228,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":229,"enrollmentInfo":230,"targetDuration":4,"studyType":60,"phases":232,"briefSummary":234,"conditions":235,"keywords":238,"overallStatus":141,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":50},"100637196","phase-1-fes-cycling-with-bfr-in-the-spinal-cord-injury-population-100637196","NCT07588503","FES Cycling With BFR in the Spinal Cord Injury Population","Assessing the Safety and Feasibility of Functional Electrical Stimulation Cycling Coupled With Blood Flow Restriction in a Spinal Cord Injury Population","Inclusion Criteria:\n\n* Adult (≥ 18 to ≤ 75yrs)\n* Male or female\n* Chronic Injury (\\>1yr)\n* Diagnosis of SCI at levels between C5 to T10 (AIS A-D) with traumatic or non-traumatic etiology.\n* ≥3 Cardiometabolic risk parameters\n\nExclusion Criteria:\n\n* A prior or current history of venous thromboembolism\n* Pressure injury of the pelvis, mid to upper thigh region, or foot\n* Managing a lower limb fracture\n* Any history of embolic stroke\n* Myocardial infarction\n* Current untreated hypertension\n* Language, psychiatric, cognitive, or communicative disability (e.g., traumatic brain injury) that compromises the participant's autonomy to voluntarily join the study, follow its instructions and\u002For operate the device.\n* Current alcohol or street drug use disorder.\n* Current use of an anticoagulant medication.\n* Frequent episodes of autonomic dysreflexia unresponsive to therapy (e.g., 3-5 times a week).\n* Unresolved deep vein thromboembolism (VTE) in the past six months.\n* Severe spasticity preventing the necessary range of motion for cycling.\n* Active implantable medical device (e.g., pacemaker, ITB pump).\n* Inability to provide informed consent.\n* Severe active concurrent medical conditions (e.g., skin or respiratory infections, lung, pressure sores).\n* Unstable spine or unhealed limbs or pelvic fractures.\n* Active heterotopic ossification interfering with the lower extremity range of motion.","75 Years",{"count":231,"type":20},6,[233],"PHASE1","Cardiometabolic Disease (CMD) is the silent killer within the spinal cord injury\u002Fdisease (SCI\u002FD) population. Many SCI\u002FD patients' initial CMD presentation is with a heart attack, stroke, or sudden cardiac death, highlighting the need for interventions to reduce CMD risk. CMD contributes to 46% of deaths, with 30-50% of the SCI\u002FD population living with undiagnosed CMD. Treating CMD risk is more challenging in the SCI\u002FD population due to prolonged inactivity, inability to exercise, and excessive caloric intake to expenditure ratio. Identifying accessible and inclusive strategies to combat CMD risk in the SCI\u002FD population is a compelling and urgent health priority.\n\nBlood flow restriction (BFR) exercise involves applying inflatable cuffs to the proximal end of an individual's limbs. Changes to the amount of blood flowing into and out of the limb lead to a low oxygen environment within the limb, shifting the way the muscles can produce the energy required to function, increasing the benefits of low- and moderate-intensity exercise. Coupling BFR with Functional electrical stimulation cycling (FES-cycling), a commonly used rehabilitation tool within the SCI population, could improve FES-cycling's short- and long-term benefits without reducing the accessibility and inclusiveness of long-term exercise prescription. Although preliminary BFR research in the SCI\u002FD has identified positive muscular improvements, whether FES-cycling coupled with BFR can be safely prescribed or feasibly implemented long-term within the SCI\u002FD population is unknown.\n\nThe proposed project aims to determine the safety and feasibility of FES-cycling coupled with BFR for 20 minutes of moderate-intensity exercise among adults with chronic spinal cord injury\u002Fdisease (SCI\u002FD). The research team aims to implement pre-test, eight exercise sessions, and post-test across 6-weeks. Criteria for success include no adverse or severe adverse events not alleviated by ceasing exercise (safety), a 1 to 8 ratio of participants screened to participants eligible (recruitment success), and participants successfully completing all exercise sessions (participant retention).",[236,24,237],"Spinal Cord Injury","Metabolic Diseases, Type 2 Diabetes, Cardiovascular Disease",[239,240,236,241,242,243],"Safety","Feasability","Blood Flow Restricted Aerobic Exercise","Functional Electrical Stimulation","Cycling","2026-05-08",{"date":246,"type":42},"2026-05-14",{"date":248,"type":20},"2026-06-15",{"date":250,"type":20},"2027-09-30",{"name":252,"class":49},"Dr. B. Catharine. Craven",{"id":254,"slug":255,"hasResults":11,"nctId":256,"briefTitle":257,"officialTitle":257,"acronym":4,"eligibilityCriteria":258,"healthyVolunteers":127,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":259,"targetDuration":261,"studyType":21,"phases":4,"briefSummary":262,"conditions":263,"keywords":4,"overallStatus":141,"whyStopped":4,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":266,"startDateStruct":268,"completionDateStruct":270,"leadSponsor":272,"locationsCount":50},"100635731","role-of-endothelial-progenitor-cells-dysregulation-and-inflammation-in-the-pathophysiology-of-cardiovascular-complications-of-type-2-diabetes-100635731","NCT07556497","Role of Endothelial Progenitor Cells Dysregulation and Inflammation in the Pathophysiology of Cardiovascular Complications of Type 2 Diabetes","Inclusion Criteria:\n\n* T2D\n* Males and females\n* Older than 18 years of age\n* Willingness to participate in the study and provide written consent form\n* Consent to having peripheral blood withdrawals and urine collection for the study requirement.\n\nExclusion Criteria:\n\n* Unable to meet the inclusion criteria\n* Type I diabetes, MODY diabetes or other form of diabetes\n* Active infection, inflammation, cancer or acute illness of any kind (other than a cardiovascular complication of diabetes if applicable in the group they are assigned to).\n* Chronic inflammation (eg. auto-immune diseases) or infections (eg. HIV, chronic hepatitis).\n* Evidence of malignancy within the past 5 years",{"count":260,"type":20},90,"6 Months","This study aims to isolate endothelial progenitor cells (EPCs) from participants with type 2 diabetes (T2D) and cardiovascular complications and to comprehensively characterize EPC dysfunction. Specifically, the study will evaluate maladaptive angiocrine signaling, calcium signaling pathways, and the role of inflammation in EPC function and the progression of atherosclerosis during T2D development. A sub-study will assess EPC functionality by examining endothelial nitric oxide synthase (eNOS) expression and activity, as well as the effectiveness of in vitro eNOS gene enhancement.",[264,24],"Diabete Type 2","2026-04-21",{"date":267,"type":42},"2026-04-29",{"date":269,"type":42},"2020-11-17",{"date":271,"type":20},"2026-12-31",{"name":273,"class":49},"Weill Cornell Medical College in Qatar",{"id":275,"slug":276,"hasResults":11,"nctId":277,"briefTitle":278,"officialTitle":278,"acronym":279,"eligibilityCriteria":280,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":281,"targetDuration":283,"studyType":21,"phases":4,"briefSummary":284,"conditions":285,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":290,"lastUpdatePostDateStruct":291,"startDateStruct":292,"completionDateStruct":294,"leadSponsor":296,"locationsCount":50},"100632601","qatar-cardiometabolic-retrospective-cohort-analysis-using-artificial-intelligence-100632601","NCT07515807","Qatar Cardiometabolic Retrospective Cohort-Analysis Using Artificial Intelligence","QCRC-AI","Inclusion Criteria:\n\n* Age ≥ 18\n* Qatari and Arab participants\n* Participants admitted for Acute Coronary Syndrome (ACS) or Acute Heart Failure (AHF)\n* Metabolic disease: Diabetes (HbA1C ≥ 6.5% or any HbA1C if a patient is on an antidiabetic agent) or pre-diabetes: 5.7% ≤ HbA1c ≤ 6.4%\n\nExclusion Criteria:\n\n* Non-Qatari or non-Arab participants\n* Non-diabetic: HbA1C \\\u003C 5.7%\n* This chart review involves no direct interaction with individuals. Prisoners are not a focus of this study, and incarceration status is not identifiable in the records reviewed.",{"count":282,"type":20},10000,"2 Years","Cardiovascular disease is the leading cause of death worldwide, and individuals with diabetes or other cardiometabolic conditions are at increased risk of adverse cardiovascular outcomes. Although advances in prevention and treatment have reduced cardiovascular events globally, cardiometabolic disease continues to represent a significant health burden, particularly in regions with high diabetes prevalence. In Qatar and other Gulf Cooperation Council countries, the prevalence of diabetes and obesity is increasing, contributing to a high proportion of participants presenting with acute coronary syndrome who have type 2 diabetes or prediabetes. This observational study will use electronic medical record data from patients hospitalized at the Heart Hospital with acute coronary syndrome and a concomitant diagnosis of diabetes or prediabetes. The study will assess trends in cardiovascular risk factors and cardiovascular events, including readmission and mortality. An artificial intelligence component will be used to develop and validate machine learning based risk prediction models to forecast adverse cardiovascular outcomes in participants with cardiometabolic disease. These models will integrate clinical, biochemical, imaging, and other non-invasive data routinely collected during participants care to identify predictors of cardiovascular events.",[24,286,287,288,289],"Acute Coronary Syndromes (ACS)","Type 2 Diabetes","Pre Diabetes","Artifical Intelligence","2026-04-15",{"date":265,"type":42},{"date":293,"type":20},"2026-07-16",{"date":295,"type":20},"2030-07-16",{"name":273,"class":49},{"id":298,"slug":299,"hasResults":11,"nctId":300,"briefTitle":301,"officialTitle":301,"acronym":302,"eligibilityCriteria":303,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":304,"targetDuration":4,"studyType":60,"phases":306,"briefSummary":307,"conditions":308,"keywords":309,"overallStatus":141,"whyStopped":4,"lastUpdateSubmitDate":314,"lastUpdatePostDateStruct":315,"startDateStruct":317,"completionDateStruct":319,"leadSponsor":321,"locationsCount":50},"100632372","evaluation-of-the-benefits-of-hypnosis-during-transoesophageal-echocardiography-100632372","NCT07512830","Evaluation of the Benefits of Hypnosis During Transoesophageal Echocardiography","HYPNOECHO","Inclusion Criteria:\n\nPatient aged ≥ 18 years old\n\n* Patient requiring a transoesophageal ultrasound scan under local anaesthetic.\n* Patient affiliated to a health insurance scheme\n* French-speaking patient\n* Patient who has given their free, informed and express verbal consent\n\nExclusion Criteria:\n\nPatient with a contraindication to transoesophageal ultrasound (significant radiation exposure to the chest, oesophageal pathology with risk of bleeding)\n\n* Patients with known schizophrenia or known psychiatric illness (documented in medical records)\n* Patients with known dementia or known cognitive impairment (documented in medical records)\n* Patients already included in an interventional research protocol\n* Patients under guardianship or curatorship\n* Patients deprived of their liberty\n* Patients under judicial protection\n* Pregnant or breastfeeding patients",{"count":305,"type":20},150,[62],"Transoesophageal echocardiography (TOE) is a routine cardiology examination that is performed in most cases under local anaesthesia and is recommended for many indications.The objective of our study will be to evaluate the expected beneficial effect of using conversational hypnosis and hypnosis during a transoesophageal ultrasound examination performed directly in the examination room by the cardiologist conducting the examination.",[24],[310,311,312,313],"stroke","endocarditis","local anaesthetic","Conversational hypnosis","2026-04-03",{"date":316,"type":42},"2026-04-06",{"date":318,"type":42},"2026-02-18",{"date":320,"type":20},"2028-12-15",{"name":322,"class":49},"Fondation Hôpital Saint-Joseph",{"id":324,"slug":325,"hasResults":11,"nctId":326,"briefTitle":327,"officialTitle":328,"acronym":329,"eligibilityCriteria":330,"healthyVolunteers":11,"sex":16,"minAge":331,"maxAge":229,"enrollmentInfo":332,"targetDuration":4,"studyType":60,"phases":334,"briefSummary":335,"conditions":336,"keywords":341,"overallStatus":141,"whyStopped":4,"lastUpdateSubmitDate":360,"lastUpdatePostDateStruct":361,"startDateStruct":363,"completionDateStruct":365,"leadSponsor":367,"locationsCount":50},"100616892","pmpr-and-chlorhexidine-on-periodontal-disease-and-vascular-function-100616892","NCT07311512","PMPR and Chlorhexidine on Periodontal Disease and Vascular Function","The Effect of Professional Mechanical Plaque Removal (PMPR) and Chlorhexidine Mouthwash on Salivary and Acquired Enamel Pellicle (AEP) Proteins and Vascular Function and Inflammation in People With Periodontal Disease","CHX-PMPR-PERIV","Inclusion Criteria:\n\n* Participants must have a minimum of 2 natural teeth in each sextant (at least 12 teeth overall).\n* Individuals with clinically diagnosed gingivitis and\u002For early periodontitis (stage 1 and 2)\n* Must not have undergone periodontal maintenance therapy (PMPR) within the last 6 months.\n* Must not currently be wearing orthodontic appliances, due to their effect on oral microbiota and plaque composition.\n* Must not be using removable orthodontic appliances, as they increase plaque accumulation.\n* Must not have taken any antibiotic treatments within the last 3 months.\n* Must be able to provide written informed consent.\n* Individuals with dental erosion or caries will still be included but matched during the baseline visit.\n\nExclusion Criteria:\n\n* Individuals under regular medication within one month of the study start date for any medical condition (such as hypertension and\u002For diabetes)\n* Pregnant or breastfeeding individuals.\n* Individuals requiring an interpreter or who are non-English speakers.\n* Individuals unable to provide written informed consent.\n* Individuals participating in another ongoing clinical study (other than observational studies) within 3 months prior to or during this study.\n* Individuals who have used mouthwash or tongue scrapers in the last 6 weeks.\n* Individuals who consume 20 or more cigarettes per day.\n* Individuals who consume more than 5 alcoholic drinks per day.","30 Years",{"count":333,"type":20},30,[62],"* Gum inflammation is called gingivitis. Gum disease, known as periodontal disease, is a long-term inflammation of the gums and bone around teeth, leading to tooth loss. Both gingivitis and periodontal disease are also linked to other health problems, including heart disease. Additionally, salivary proteins play a role in maintaining oral health. For example, a protective layer called the salivary pellicle (SP) forms on teeth after tooth brushing and helps defend against harmful bacteria.\n* Nitrate-reducing bacteria (NRB) are also present in saliva and play a role in oral and cardiovascular health by converting nitrate to nitric oxide (NO). This compound supports blood vessel health and overall cardiovascular function. Therefore, NRB's abundance is linked to lower blood pressure and improved cardiovascular health.\n* Standard treatments for gum disease include deep cleaning (also called professional mechanical plaque removal, or PMPR), and sometimes chlorhexidine (CHX) mouthwash is used with PMPR to help reduce mouth bacteria. However, while CHX is effective against plaque (a sticky film of bacteria on the tooth surface), it may reduce the activity of \"nitrate-reducing\" bacteria (NRB), which are important for producing nitric oxide (NO).\n* This study investigates the impact of deep cleaning (PMPR) with and without Chlorhexidine mouthwash on salivary and SP proteins, as well as blood vessel function, in people who have gum disease. By examining these links, the investigators aim to gain a deeper understanding of how oral care practices may impact overall health, particularly heart health.",[337,24,338,339,340],"Periodontal Disease (PD)","Oral-Systemic Link","Vascular Dysfunction","Endothelial Function and Arterial Stiffness",[342,343,344,345,346,347,348,349,350,351,352,353,354,355,356,338,357,358,359],"Chlorhexidine Mouthwash","Periodontal Disease","Professional Mechanical Plaque Removal (PMPR)","Salivary Proteins","Acquired Enamel Pellicle (AEP)","Proteomics","Vascular Function","Endothelial Function","Flow-Mediated Dilation (FMD)","Pulse Wave Analysis (PWA)","Pulse Wave Velocity (PWV)","Blood Pressure","Nitric Oxide","Nitrate reducing bacteria (NRB)","Inflammation biomarkers","Saliva Collection","Blood Sample Collection","Cardiac Output","2026-03-23",{"date":362,"type":42},"2026-03-25",{"date":364,"type":42},"2026-01-23",{"date":366,"type":20},"2028-07-01",{"name":368,"class":49},"Mahdi Mutahar",{"id":370,"slug":371,"hasResults":11,"nctId":372,"briefTitle":373,"officialTitle":374,"acronym":375,"eligibilityCriteria":376,"healthyVolunteers":127,"sex":16,"minAge":377,"maxAge":378,"enrollmentInfo":379,"targetDuration":283,"studyType":21,"phases":4,"briefSummary":381,"conditions":382,"keywords":391,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":401,"lastUpdatePostDateStruct":402,"startDateStruct":404,"completionDateStruct":405,"leadSponsor":407,"locationsCount":50},"100626909","thromboembolic-risk-associated-to-high-atrial-fibrillation-risk-100626909","NCT07441759","throMboembolic Risk Associated To High atrIal Fibrillation riSk","Economic, Clinical, and Societal Impact of Early Thromboembolic -Risk Detection in High-Risk Atrial Fibrillation: A Model -Based Evaluation of the MATHIAS Strategy.","MATHIAS","Inclusion Criteria (PREFATE study): assessed at baseline\n\n* Adults aged 65-95 years without prior AF and at High risk of AF, according to the risk score validated in the AFRICAT (Atrial Fibrilation Research in CATalonia) study. This scale considers the following variables for risk calculation: sex, age, weight, cardiac rate and CHA2DS2-VASc (congestive heart failure, hypertension, age ≥75 (doubled), diabetes mellitus, prior stroke or transient ischemic attack (doubled), vascular disease, age 65-74, female) score.\n* with active records in the HCC3\u002FCMBD systems\n* CHA2DS2-VASc score≥2.\n* Ability to use a smart phone (or at least the caregiver).\n\nExclusion Criteria: Patients with the following conditions will be excluded (exclusion criteria):\n\n* Previous diagnosis of AF.\n* Previous diagnosis of stroke.\n* Severe cognitive impairment, with a score on the Global Deterioration Scale (GDS)≥3.\n* Severe functional impairment, with a Barthel score ≤60, or modified Rankin score≥4.\n* Active anticoagulant treatment at the inclusion.\n* Vital prognosis less than 1 year.\n* Pacemaker carriers.","65 Years","95 Years",{"count":380,"type":20},1000,"Cardiovascular diseases are the leading cause of mortality from treatable conditions in the European Union and the second from preventable causes, with a standardized mortality rate of 257.8 deaths per 100,000 inhabitants. In 2022, more than 1.11 million deaths in individuals under 75 years could have been avoided. Atrial fibrillation (AF) and major adverse cardiovascular events (MACE) are highly prevalent in the elderly and generate substantial healthcare costs. AF significantly increases the risk of MACE and is projected to rise markedly in the coming decades.\n\nIn Europe, AF prevalence is expected to increase 2.5-fold over the next 50 years, with a lifetime risk of 1 in 3-5 individuals after age 55. AF-related strokes are projected to increase by 34%, and ischemic strokes in individuals over 80 are expected to triple between 2016 and 2060. Additionally, a 27% increase is anticipated among stroke survivors who subsequently develop AF or related conditions. AF substantially impacts morbidity, mortality, and disease progression, and early detection and treatment are crucial to prevent severe outcomes.\n\nEuropean action plans (2018-2030) and the 2024 ESC\u002FESO guidelines emphasize early detection and management of AF in primary care. Although several AF prediction models exist, their integration into clinical practice remains challenging. AF represents a clinical continuum, with thrombotic risk present even before arrhythmia onset. High-risk patients for AF also show a high incidence of MACE, defined as a composite of myocardial infarction, stroke, systemic embolic events, and cardiovascular death.\n\nThe proposed strategy involves developing and clinically validating an Artificial Intelligence (AI) model to improve early thrombotic risk prediction in patients at high risk of AF, using MACE as the primary outcome. This model aims to outperform the traditional CHA₂DS₂-VASc score by incorporating both classical and emerging clinical factors. The estimated timeline from clinical validation to commercialization is approximately 48 months.\n\nAI-based prediction is expected to enable personalized treatment, reduce the incidence of MACE, hospitalizations, and disability, and improve cost-effectiveness, ultimately decreasing the social and economic burden of AF and stroke in Europe.",[383,384,385,386,387,388,389,24,390],"MACE","Atrial Fibrillation (AF)","Quality-adjusted Life-years","Electronic Health Records","Thromboembolic Risk","Cost-effectiveness Analysis","Artificial Intelligence (AI)","Cardio-cerebrovascular Disease",[392,393,394,395,396,397,398,399,400],"Atrial fibrillation","Thromboembolic risk","Artificial intelligence","Stroke","Major Adverse Cardiovascular Events","Sex differences","Primary care","Cost-effectiveness analysis","Quality-adjusted life-years","2026-02-27",{"date":403,"type":42},"2026-03-02",{"date":44,"type":20},{"date":406,"type":20},"2028-12-31",{"name":408,"class":49},"Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina",{"id":410,"slug":411,"hasResults":11,"nctId":412,"briefTitle":413,"officialTitle":414,"acronym":415,"eligibilityCriteria":416,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":417,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":419,"conditions":420,"keywords":422,"overallStatus":141,"whyStopped":4,"lastUpdateSubmitDate":426,"lastUpdatePostDateStruct":427,"startDateStruct":429,"completionDateStruct":431,"leadSponsor":433,"locationsCount":435},"100626222","assessment-of-the-association-between-sleep-disorders-detected-by-a-simplified-questionnaire-and-cardiovascular-diseases-100626222","NCT07432828","Assessment of the Association Between Sleep Disorders Detected by a Simplified Questionnaire and Cardiovascular Diseases","Assessment of the Association Between Sleep Disorders Detected by a Simplified Questionnaire and Cardiovascular Diseases: a Prospective Study in Cardiology Consultations","CARDIOSOM","Inclusion Criteria - Patient :\n\n* Adult patients (≥18 years old) consulting in cardiology.\n* Ability to complete the questionnaire.\n* No objection\n\nInclusion Criteria - Cardiologist:\n\nCardiologists who participated in CARDIOSOM and who conduct cardiology consultations that include a systematic or non-systematic assessment of their patients' sleep quality (duration, regularity, insomnia, sleepiness, suspected obstructive sleep apnea (OSA)) and whether or not suspected sleep disorders in patients are treated.\n\nExclusion Criteria - Patient :\n\n* Active treatment for a severe sleep disorder (severe sleep apnea under CPAP (Continuous Positive Airway Pressure) or orthotic device, narcolepsy, chronic insomnia being treated)\n* Refusal to participate\n\nExclusion Criteria - Cardiologist :\n\nNot applicable",{"count":418,"type":20},1500,"The goal of this observational study is to validate a simplified questionnaire, adapted for routine clinical use, to quickly detect sleep disorders in patient during a cardiology consultation.\n\nTwo questionnaires were developed for this project. The first is patient-oriented: a prospective, multicentre, national observational registry based on a patient questionnaire designed to quickly detect sleep disorders during a cardiology consultation.\n\nThe second is aimed at treating cardiologists: this is a simple impact survey designed to assess changes in the practices of cardiologists who participated in CARDIOSOM.",[421,24],"Sleep Disorder (Disorder)",[423,424,425],"sleep disorders","risk of cardiovascular conditions","simplified questionnaire","2026-02-19",{"date":428,"type":42},"2026-02-25",{"date":430,"type":42},"2026-01-15",{"date":432,"type":20},"2027-01",{"name":434,"class":49},"French Cardiology Society",2,{"id":437,"slug":438,"hasResults":11,"nctId":439,"briefTitle":440,"officialTitle":441,"acronym":4,"eligibilityCriteria":442,"healthyVolunteers":11,"sex":16,"minAge":443,"maxAge":4,"enrollmentInfo":444,"targetDuration":4,"studyType":60,"phases":446,"briefSummary":447,"conditions":448,"keywords":453,"overallStatus":141,"whyStopped":4,"lastUpdateSubmitDate":364,"lastUpdatePostDateStruct":458,"startDateStruct":460,"completionDateStruct":462,"leadSponsor":464,"locationsCount":50},"100622157","effects-of-wearable-device-functions-and-health-coaching-on-device-measured-movement-behaviours-and-cardiometabolic-risk-factors-in-adults-with-central-obesity-100622157","NCT07379970","Effects of Wearable Device Functions and Health Coaching on Device-measured Movement Behaviours and Cardiometabolic Risk Factors in Adults With Central Obesity","Effects of Wearable Device Functions and Health Coaching on Device-measured Movement Behaviours and Cardiometabolic Risk Factors in Adults With Central Obesity: a Randomised Controlled Trial","Inclusion Criteria:\n\n* Age 40 years or older\n* Central obesity, defined as waist circumference: ≥90 cm for men; ≥80 cm for women\n* Insufficient physical activity based on World Health Organization (WHO) guidelines\n* Physical activity assessed using the International Physical Activity Questionnaire (IPAQ) - Short Form\n* Ownership of a smartphone\n* Able to read and understand English or Chinese\n\nExclusion Criteria:\n\n* unable to perform daily-life activities, based on the Physical Activity Readiness-Questionnaire (PAR-Q) (24) and\u002For participation in another lifestyle-change intervention study.","40 Years",{"count":445,"type":20},133,[62],"This study is a randomized controlled trial. The objective of this study is to investigate:\n\n1. the effects of 1-year evidence-based interventions incorporating wearable device functions alone on device-measured movement behaviours and cardiometabolic risk factors among adults with central obesity; and\n2. the effects of 1-year evidence-based interventions incorporating wearable device functions combined with health coaching on device-measured movement behaviours and cardiometabolic risk factors among adults with central obesity.\n\nWe hypothesise that the use of wearable device functions in combination with health coaching will lead to significantly greater improvements in device-measured movement behaviours and cardiometabolic risk factors compared with no intervention and wearable device functions alone, both after the 12-month intervention and at the 6-month follow-up.\n\nThis study will implement a parallel-group, open-label, 1-year randomized controlled trial involving 133 adults aged 40 years or older with central obesity. The trial will examine the effects of a cutting-edge intervention using evidence-based wearable device functions alone or in combination with evidence-based health coaching on movement behaviours and cardiometabolic risk factors.\n\nAll participants will provide written informed consent prior to participation and will be informed that they may withdraw from the study at any time during the study period. A staff member without access to participant information will generate a computer-based randomization list using permuted blocks of six, with two participants allocated to each of the three groups (two intervention groups and one control group) per block, in a 2:2:2 allocation ratio.\n\nThe control group will not receive a Fitbit device and will be asked to continue their usual lifestyle. The two intervention groups will use four evidence-based Fitbit functions: step goal setting, sleep goal setting, activity prompts, and community functions. The key difference between the two intervention groups is that one group will additionally receive a structured health coaching program adapted from the U.S. Centers for Disease Control and Prevention (CDC) National Diabetes Prevention Program (NDPP), as used in our prior trial.\n\nThe CDC NDPP recommends that at least 22 health coaching sessions be delivered over a 1-year period, depending on participants' needs, and provides corresponding curricula and handouts outlining session content. Coaching sessions will be delivered by trained research staff who have received appropriate professional training in health coaching delivery.\n\nThe lifestyle change program will include, but not be limited to:\n\n1. education on cardiometabolic disease risk factors (e.g., type 2 diabetes, coronary heart disease, and stroke);\n2. goal planning and goal setting;\n3. strategies for self-monitoring physical activity, sleep, diet, and stress;\n4. strategies for initiating and maintaining favourable levels of physical activity, diet, and sleep;\n5. strategies for obtaining support from family, friends, and co-workers; and\n6. review of achievements and challenges during the intervention period, with goal setting and planning for the subsequent 6-month follow-up period.\n\nParticipants will attend the research laboratory on three occasions: at baseline, immediately after the 12-month intervention, and at the 6-month follow-up. Assessments will include demographic information, standing height, body weight, body mass index, waist circumference, hip circumference, waist-to-hip ratio, systolic and diastolic blood pressure, and questionnaires.\n\nAt each laboratory visit, one EDTA blood sample and one clotted blood sample will be collected by a trained phlebotomist and analysed by an accredited medical diagnostic centre to assess cardiometabolic risk markers, including total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides.\n\nAn Axivity AX6 device will be used as a research-grade accelerometer to assess movement behaviours, including sleep, sedentary time, light physical activity, moderate-to-vigorous physical activity (MVPA), steps, energy expenditure, and resting heart rate. Participants will also be asked to wear the Axivity device on the dominant wrist for seven consecutive days at baseline and post-intervention.\n\nResearch staff will access participants' Fitbit web accounts to extract Fitbit data, activate Fitbit functions for the intervention groups, and monitor device battery life. Reminders to wear and charge the Fitbit and research-grade accelerometer will be sent every seven days via WhatsApp to promote protocol compliance. To further support adherence, participants who complete all study assessments will receive a HKD 500 supermarket voucher.",[449,24,450,451,452],"Fitness Trackers","Physical Activities","Exercise","Health Coaching",[454,455,456,457],"movement behavior","NDPP Program","randomized controlled trial","wearable technology",{"date":459,"type":42},"2026-02-02",{"date":461,"type":42},"2025-01-01",{"date":463,"type":20},"2027-12-31",{"name":465,"class":49},"The University of Hong Kong",{"id":467,"slug":468,"hasResults":11,"nctId":469,"briefTitle":470,"officialTitle":471,"acronym":472,"eligibilityCriteria":473,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":474,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":475,"conditions":476,"keywords":4,"overallStatus":141,"whyStopped":4,"lastUpdateSubmitDate":478,"lastUpdatePostDateStruct":479,"startDateStruct":481,"completionDateStruct":483,"leadSponsor":485,"locationsCount":50},"100616924","rapid-escalation-of-lipid-lowering-therapy-to-reduce-recurrent-cardiovascular-event-100616924","NCT07311941","Rapid Escalation of LipiD Lowering Therapy to Reduce RecUrrent Cardiovascular Event","Rapid Escalation of LipiD Lowering Therapy to Reduce RecUrrent Cardiovascular Event (REDUCE) : All Comers Study","REDUCE-Lipid","Inclusion Criteria:\n\n* Age \\>18\n* (Cohort 1) Diagnosis of acute coronary syndrome due to atherosclerotic coronary artery disease\n* (Cohort 2) Diagnosis of chronic coronary syndrome due to atherosclerotic coronary artery disease\n\nExclusion Criteria:\n\n* Inability to provide valid consent by the patient or his legal guardian\n* Diagnosis of ACS due to other causes than atherosclerotic coronary artery disease.\n* Psychiatric or severe neurological disorder, cirrhosis, or active malignancy leading to a life expectancy \\\u003C 6 months.",{"count":380,"type":20},"Hyperlipidaemia especially elevation of low-density lipoprotein cholesterol (LDL-C) is known to be the main contributor to the development of atherosclerotic cardiovascular disease (ASCVD).\n\nLowering LDL-C have been shown to reduce the risk of ASCVD2,3. Both the American Heart Association (AHA) and the European Society of Cardiology (ESC) advocated aggressive LDL-C target with statin being the first-line lipid-lowering therapy (LLT). However, a significant portion of patients did not attain their LDL-C goal in our locality. Statin no adherence, low uptake of adjuvant non-statin LLT, and therapeutic inertia are few potential causes for not achieving the LDL-C target. ESC recommends repeating blood test in 6-8 weeks after addition or alternation of LLT, but this recommendation was not routinely followed in current local practice due to resources constrain.\n\nThis registry therefore aims to investigate the strategy of frequent monitoring of LDL-C and titration of LLT in achieving LDL-C treatment target at a dedicated specialist clinic.",[477,24],"Hyperlipidemia","2025-12-17",{"date":480,"type":42},"2025-12-31",{"date":482,"type":42},"2024-12-30",{"date":484,"type":20},"2031-06-30",{"name":486,"class":49},"Chinese University of Hong Kong",{"id":488,"slug":489,"hasResults":11,"nctId":490,"briefTitle":491,"officialTitle":491,"acronym":4,"eligibilityCriteria":492,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":493,"targetDuration":4,"studyType":60,"phases":494,"briefSummary":495,"conditions":496,"keywords":502,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":504,"lastUpdatePostDateStruct":505,"startDateStruct":507,"completionDateStruct":509,"leadSponsor":511,"locationsCount":4},"100614424","activate-tennessee-a-chw-supported-program-for-patient-activation-100614424","NCT07279415","Activate Tennessee: A CHW-Supported Program for Patient Activation","Inclusion criteria:\n\n* 18 years and older,\n* Able to speak and understand English\n* Have been told by a health care provider that they have two or more, chronic health conditions\n* Are classified as medically underserved or socially vulnerable person",{"count":161,"type":20},[62],"The research project will involve community health workers (CHWs) that will help participants to better understand their medical conditions and to responsibly manage their medical needs. The project will focus on participants with the greatest medical needs and those that have many different illnesses at the same time. CHWs will help guide participants in focusing on improving their knowledge and confidence to manage their health conditions and to improve their ability to understand how the healthcare system works. This will give participants the opportunity to take charge of their illnesses and possibly improve their health conditions over time. The CHWs will work together with participants to develop a health plan focused on their specific health needs.",[497,498,24,499,500,501],"Diabetes","Hypertension","Infectious Diseases Morbidity","Chronic Kidney Disease","Hypercholesterolemia",[503],"community health worker, co-morbidities","2025-12-09",{"date":506,"type":42},"2025-12-12",{"date":508,"type":20},"2025-12-20",{"date":510,"type":20},"2027-09",{"name":512,"class":49},"Meharry Medical College",{"id":514,"slug":515,"hasResults":11,"nctId":516,"briefTitle":517,"officialTitle":517,"acronym":518,"eligibilityCriteria":519,"healthyVolunteers":127,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":520,"targetDuration":4,"studyType":60,"phases":522,"briefSummary":523,"conditions":524,"keywords":534,"overallStatus":141,"whyStopped":4,"lastUpdateSubmitDate":546,"lastUpdatePostDateStruct":547,"startDateStruct":549,"completionDateStruct":551,"leadSponsor":553,"locationsCount":435},"100611237","cocreating-action-to-improve-rationality-in-the-health-system-100611237","NCT07237971","Cocreating Action to Improve Rationality in the Health System","CAIR","Survey general population:\n\nA representative population survey of adult (aged 18 years and over) who are residents in the Municipal District 2 of Elche (Spain).\n\nSurvey community pharmacies:\n\nIndividuals who visit the pharmacies collaborating in the Municipal District 2 of Elche (Spain) to obtain any of the medications, aged 18 years and over for three a priori established medication groups.\n\n* Group 1 (Antidepressants and Anxiolytics): N05B, N05C, N06A.\n* Group 2 (Cardiovascular disease risk factor medication): A10B (antidiabetics), C10A (cholesterol-lowering drugs), C07A, C09A, C03C, C08C (antihypertensives).\n* Group 3 (Antibiotics): J01\n\nHealth service data from primary care:\n\nA series of aggregate indicators will be collected from the electronic information systems of the regional health authorities (Conselleria de Sanidad de la Generalitat Valenciana), which hosts information on both prescriptions made by physicians and those dispensed in the community pharmacies of the Valencian Community. These indicators will be calculated for individuals aged 18 years and over for groups 2 and 3, and 12 years and over for group 1 using aggregate data from health system's registries and, therefore, not considering 12 years old as minimum age limit of the eligible participants in the present study protocol registry. Furthermore, aggregate data about the number of consultations will be collected in the two primary care facilities in the study area for individuals aged 18 and over.\n\nQualitative methods and cocreation procedure:\n\nFocus groups, sociograms and in-depth interviews will include 6-8 participants and last approximately 90 minutes. Participation in the co-creation process will be open, voluntary, and will depend on the interest of individuals and entities in the area. Eligibility criteria:\n\n* People aged 18 and over who are residents or have a job or family connection in the Municipal District 2 of Elche (Spain) who are interested in participating, wish to be actively involved in the co-creation, planning, and implementation of community initiatives, and are available to attend the conferences, meetings, and workshops.\n* Representatives from community institutions and associations, including professionals from the Elche Public Health Center, primary care teams in the area, Elche Council staff, as well as professionals and volunteers from NGOs and other local organizations with experience in community work in the district.",{"count":521,"type":20},4000,[62],"Despite widespread recognition of social, economic, or environmental health determinants, health action remains heavily dominated by individual-level solutions (e.g., medication, patient counselling, vaccination). This study aims to stimulate changes in health system functioning by demonstrating how the cocreation of actions to address psychological well-being, cardiovascular health, and antimicrobial resistance from within the community can alleviate the burden on primary care services, reduce medicalisation and increase health equity.\n\nThe scientific approach uses mixed methods and incorporates theory from multiple disciplines. This study will appraise how the current system addresses psychological well-being, cardiovascular (CV) health, and rational use of antibiotics using a population survey, a survey of patients collecting their medication at community pharmacies, aggregate health service indicators on medication consumption and primary care consultations, and qualitative methods exploring stakeholders' perceptions.The investigators will undertake community-based participatory research to engage citizen scientists in the cocreation of community-led actions to promote psychological well-being, CV health, and prevent antimicrobial resistance. The design, implementation, and evaluation of the actions will apply an assets-based approach and apply theories and frameworks from implementation science in an iterative manner over 3 years. Finally, the impact of the cocreated actions will be analysed, considering effectiveness and broader contextual issues such as initiative adoption, implementation, and maintenance. The investigators will use a before-after comparison of survey indicators, an interrupted time-series analysis of health service data and qualitative analysis.\n\nThe goal is to demonstrate how the integration of community action with attention to the social determinants of health, can lead to a more rational approach to health care and ultimately improve health and health equity.",[525,526,527,528,529,530,24,531,532,533],"Health-Related Quality-of-Life","Social Capital","Health Literacy","Community Based Participatory Research","Antibiotic Prescription","Mental Health Literacy","Antimicrobial Drug Resistance","Well-being","Health Equity",[535,536,537,538,539,540,541,542,543,544,545],"Community health","Cocreation action","Health system","Health literacy","Social capital","Community capital","Antibiotic drug use","Cardiovascular drug use","Psychotropic drug use","Health-related quality of life","Health equity","2025-11-24",{"date":548,"type":42},"2025-12-02",{"date":550,"type":42},"2025-10-21",{"date":552,"type":20},"2029-04-01",{"name":554,"class":49},"Universidad Miguel Hernandez de Elche",{"id":556,"slug":557,"hasResults":11,"nctId":558,"briefTitle":559,"officialTitle":560,"acronym":561,"eligibilityCriteria":562,"healthyVolunteers":127,"sex":16,"minAge":563,"maxAge":564,"enrollmentInfo":565,"targetDuration":4,"studyType":60,"phases":567,"briefSummary":568,"conditions":569,"keywords":577,"overallStatus":141,"whyStopped":4,"lastUpdateSubmitDate":587,"lastUpdatePostDateStruct":588,"startDateStruct":590,"completionDateStruct":592,"leadSponsor":594,"locationsCount":50},"100599548","norwegian-mental-illness-heart-health-study-100599548","NCT07085923","Norwegian Mental Illness Heart Health Study","Dietary Counselling And Exercise To Combat Cardiovascular Disease Risk In Norwegian Patients With A Severe Mental Illness","NORMI-Heart","Inclusion Criteria:\n\n* Diagnosis of F20-29 (schizophrenia spectrum) or F31 (bipolar affective disorder)\n* Current use of antipsychotic medication (first- or second generation) or lithium\n* Body Mass Index \\> or = 27 kg\u002Fm\\^2\n\nExclusion Criteria:\n\nPsychiatric condition:\n\n* Inability to provide informed consent\\*\n* Acute psychiatric crisis\\*\n* Significant cognitive impairment\\* \\*These criteria will be evaluated and confirmed by the participant's primary mental health care provider before enrollment\n\nMedication initiated during the intervention period:\n\n* GLP-1 receptor agonists\n* Antihypertensive medication\n* Antidiabetic medication\n* Lipid-lowering medication\n\nAlcohol consumption:\n\n-More than 14 units per week (men) or more than 7 units per week (women)\n\nSomatic conditions:\n\n* Type 1 diabetes\n* Established cardiovascular disease\n* Body Mass Index (BMI) \\\u003C27 kg\u002Fm²\n* Pregnancy\n* Inability to perform physical exercise\n\nSomatic risk findings at baseline:\n\n* HbA1c \\>57 mmol\u002Fmol (7.4%)\n* LDL cholesterol \\>5.0 mmol\u002FL\n* Blood pressure \\>180\u002F100 mmHg\n* Active malignant disease","25 Years","70 Years",{"count":566,"type":20},70,[62],"Norwegian patients with severe mental illnesses (SMI), such as schizophrenia spectrum or bipolar disorder, lose on average 10 years of life compared to mentally healthy individuals. Much of this gap is due to heart disease. Unhealthy lifestyle habits, including poor diet and physical inactivity, contribute to higher levels of metabolic risk factors for heart disease in this population.\n\nThe goal of this clinical trial is to find out if a lifestyle program including dietary counselling and regular physical exercise can help people with SMI to improve their physical and mental health.\n\nThe main questions it aims to answer are:\n\n* Does adherence to a healthy lifestyle program lead to reduced estimated risk of heart disease?\n* Does it change lifestyle habits, body weight and composition, and metabolic risk markers over six months?\n* Can participants with severe mental illness complete a healthy lifestyle program, and do they find it acceptable?\n\nResearchers will compare two groups: one that receives the lifestyle program in addition to regular mental health care, and one that receives regular care only.\n\nDuring the six month program, participants in the lifestyle group will:\n\n* Meet with a clinical dietitian once a month for dietary counselling\n* Take part in group-based physical activity sessions once a month, and receive support to follow a personal training plan\n\nAround 70 adults will take part in the study. The results may help improve the way lifestyle support is offered to people living with severe mental illness and inform health care providers about strategies to improve physical health in this vulnerable group.",[24,570,571,572,573,574,575,576],"Metabolic Syndrome (MetS)","Severe Mental Disorder","Schizophrenia and Schizophrenia Spectrum Psychosis","Bipolar Disease Type I","Overweight and\u002For Obesity","CVD Risk Factors","Severe Mental Illness",[576,578,579,580,451,581,582,583,584,585,586],"Cardiovascular Disease","Lifestyle Intervention","Healthy Diet","CVD-risk","Schizophrenia","Antipsychotic Medication","Bipolar Disorder","Non-pharmacological intervention","Clinical Dietitian","2025-09-26",{"date":589,"type":42},"2025-10-02",{"date":591,"type":42},"2025-09-16",{"date":593,"type":20},"2028-06-30",{"name":595,"class":49},"Madeleine Elisabeth Angelsen",{"id":597,"slug":598,"hasResults":11,"nctId":599,"briefTitle":600,"officialTitle":600,"acronym":4,"eligibilityCriteria":601,"healthyVolunteers":11,"sex":16,"minAge":602,"maxAge":564,"enrollmentInfo":603,"targetDuration":4,"studyType":60,"phases":604,"briefSummary":605,"conditions":606,"keywords":610,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":617,"lastUpdatePostDateStruct":618,"startDateStruct":620,"completionDateStruct":622,"leadSponsor":624,"locationsCount":4},"100603027","assessing-the-feasibility-of-multimedia-interventions-to-reduce-blood-pressure-in-marginalized-hypertensive-communities-of-karachi-pakistan-100603027","NCT07131176","Assessing the Feasibility of Multimedia Interventions to Reduce Blood Pressure in Marginalized Hypertensive Communities of Karachi, Pakistan","Inclusion Criteria:\n\n* Participants will be hypertension patients with an active primary healthcare clinic registration from eight chosen clinics situated in Karachi, Pakistan's slums.\n* Anyone between the ages of 21 and 70 who has been diagnosed with hypertension at one of SINA's participating clinics in the last 30 days is eligible to participate.\n* Participants will be required to take medicine to control their blood pressure,\n* sign an informed consent form,\n* attend primary healthcare clinic on a regular basis, and\n* have proficiency in five local languages: Urdu, Sindhi, Balochi, Pashto, or Punjabi.\n\nExclusion Criteria:\n\n* a patient's pregnancy or lactation status, a history of cancer that may necessitate medication changes,\n* a blood pressure reading greater than 220\u002F120 mmHg,\n* a disability that prevents the patient from reading, writing, communicating, or watching television, and participation in any other study.","21 Years",{"count":305,"type":20},[62],"This study utilizes the I-Change Model to empower individuals in literacy-limited settings, where the majority of the population is illiterate. By leveraging multimedia tools-such as an educational video and a pictorial infographic-we aim to promote self-care practices among individuals suffering from hypertension. Through these tailored interventions, we seek to enhance awareness, improve hypertension management, and encourage behavioral change, even in low-literacy communities",[498,24,607,608,609],"Educational Intervention","Self Care","Video Streaming",[611,612,613,614,615,616],"high blood pressure","self-care","hypertension","I-changed model","marginalized population","educational intervention","2025-08-12",{"date":619,"type":42},"2025-08-20",{"date":621,"type":20},"2025-12-15",{"date":623,"type":20},"2026-12-30",{"name":625,"class":49},"SINA Health Education and Welfare Trust",{"id":627,"slug":628,"hasResults":11,"nctId":629,"briefTitle":630,"officialTitle":630,"acronym":4,"eligibilityCriteria":631,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":632,"targetDuration":4,"studyType":60,"phases":634,"briefSummary":635,"conditions":636,"keywords":644,"overallStatus":141,"whyStopped":4,"lastUpdateSubmitDate":650,"lastUpdatePostDateStruct":651,"startDateStruct":653,"completionDateStruct":655,"leadSponsor":657,"locationsCount":50},"100597765","the-role-of-swan-ganz-catheter-in-hemodynamic-resuscitation-for-patients-with-cardiogenic-shock-100597765","NCT07062744","The Role of Swan-Ganz Catheter in Hemodynamic Resuscitation for Patients With Cardiogenic Shock","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Provided written informed consent to participate in the study.\n* Diagnosed with cardiogenic shock due to acute myocardial infarction according to IABP-SHOCK II (2012) criteria:\n\n  * Systolic blood pressure (SBP) \\\u003C 90 mmHg for at least 30 minutes, or requiring vasopressor agents to maintain SBP \\> 90 mmHg.\n  * Evidence of end-organ hypoperfusion, indicated by at least one of the following: Altered mental status, Urine output \\\u003C 30 mL\u002Fhour, Cold extremities with mottled skin, Serum lactate level \\> 2 mmol\u002FL.\n\nExclusion Criteria:\n\n* Presence of cervical cellulitis.\n* Inability to identify neck anatomy or history of cervical radiotherapy.\n* Coagulopathy (INR \\> 1.5 and\u002For platelet count \\\u003C 50 G\u002FL).\n* End-stage chronic diseases, including: Advanced malignancy, advanced-stage HIV, bedridden patients for more than 3 months, decompensated liver cirrhosis (Child-Pugh class C).\n* Patients with cardiac arrest or mechanical complications such as myocardial rupture prior to Swan-Ganz catheterization.\n* Congenital heart defects or intracardiac shunts. Refusal of participation by the patient or their legal representative.",{"count":633,"type":20},108,[62],"This clinical trial examines whether the use of the Swan-Ganz catheter, a specialized pulmonary artery catheter, can improve hemodynamic management and treatment outcomes in patients experiencing cardiogenic shock due to acute myocardial infarction (AMI).\n\nCardiogenic shock is a critical condition marked by the heart's inability to supply adequate blood to the organs, often resulting from a severe heart attack. Despite advancements in care, the condition remains associated with high mortality. Effective monitoring of cardiovascular status is crucial in guiding timely and tailored treatment decisions.\n\nParticipants in this study will undergo advanced hemodynamic monitoring using the Swan-Ganz catheter, which provides continuous data on cardiac output and other key parameters. This information enables physicians to better assess circulatory function and adjust therapies accordingly.\n\nThe research will evaluate clinical characteristics, response to treatment, and 30-day outcomes in patients managed with this technique. The study also aims to identify factors associated with successful hemodynamic stabilization and potential complications related to catheter use.\n\nA total of 108 adult patients meeting specific eligibility criteria will be enrolled at Bach Mai Hospital over 3 years. Participation is voluntary, and all patients will continue to receive standard-of-care treatment. All personal and medical data will be handled with strict confidentiality.",[69,637,638,639,640,641,642,643,24],"Pulmonary Artery Catheter Waveform Interpretation","Hemodynamic Management","Hemodynamic Optimization","Hemodynamic Monitoring","Acute Myocardial Infarction (AMI)","Critical Care, Intensive Care","Emergency",[645,646,73,647,648,649],"Swan-Ganz","Pulmonary Artery Catheter","Hemodynamic management","Invasive hemodynamic","Right Heart Catheter","2025-07-10",{"date":652,"type":42},"2025-07-14",{"date":654,"type":42},"2025-05-27",{"date":656,"type":20},"2027-12-30",{"name":658,"class":49},"Bach Mai Hospital",{"id":660,"slug":661,"hasResults":11,"nctId":662,"briefTitle":663,"officialTitle":664,"acronym":665,"eligibilityCriteria":666,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":667,"targetDuration":4,"studyType":60,"phases":669,"briefSummary":670,"conditions":671,"keywords":678,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":690,"lastUpdatePostDateStruct":691,"startDateStruct":693,"completionDateStruct":695,"leadSponsor":696,"locationsCount":50},"100595747","supporting-patients-starting-new-medicines-evaluating-the-mycare-start-service-in-switzerland-100595747","NCT07036471","Supporting Patients Starting New Medicines: Evaluating the myCare Start Service in Switzerland","Evaluation of the myCare Start Service to Support Patients Starting a New Medicine in Switzerland: A Hybrid Type II Effectiveness-implementation Study","myCare Start-I","Patients\n\nInclusion Criteria:\n\n* Must have mandatory basic health insurance in Switzerland\n* Must have been newly prescribed one or more new long-term medications in accordance with the following chronic conditions: cadisovascular diseases (incl. hyertension and thromboprophylaxis), diabetes, hyperlipidemia, depression, respiratory illness (asthma and COPD)\n* Must be able to self-manage treatment (i.e. they live at home without any support to manage their medication, exception: patient uses a pill dispenser and fills it in by him-\u002Fherself)\n* Must be able to understand language spoken by pharmacy staff and can read and understand study documents (French, German, English)\n* Must understand and are willing to consent to the myCare Start-I study (including the agreement on self-reported questionnaires and collection of health care data via their health insurance company)\n* in the intervention arm, patients must receive the myCare Start service\n\nFor this study, a new medication is a medication that has not been previously dispensed to the patient. This includes one or more new medications for a new diagnosis and or new medications for pre-existing diagnosis of a long-term condition. Included in this working definition:\n\n* The new medication is indicated for one of the five long-term diseases listed above\n* Patient has never had this active ingredient dispensed before (patient still considered eligible if they have received a small initial sample pack from their physician) or restarts an active ingredient after a period of interruption of at least 12 months (time period to be reported by the patient). Please note that for patients, that have already started a sample pack of medication the myCare Start Consultation One can start upon first dispensation at the pharmacy, there is no need to wait 7-14 days.\n* The new active ingredient can be part of a combo preparation (e.g. a diuretic added to an ACE inhibitor into the same preparation)\n* Patient has had no change in active ingredient but has an important change in treatment administration, such as:\n\n  * Change of galenic form (e.g. two different types of inhalators for asthma\u002FCOPD)\n  * Intensification of dosage regiment (e.g. twice a day instead of once a day)\n* The following change is not considered as medication initiation:\n\n  * New dosage of already known active ingredient (e.g. dose escalation of antidepressants)\n  * Simplification of administration mode (e.g. metformin 1000 mg 1-0-0 instead of 500 mg 1-0-1; change in antihypertensive drug regiment in elderly patients having vertigo in the morning: 0-0-X instead of X-0-0)\n\nExclusion Criteria:\n\n* Patients participating or having participated in an education program about their disease or treatment in the last 3 months, led by healthcare providers such as physicians, nurses, pharmacists or other (e.g. education provided by nurses for type I diabetes patients)\n\nPhysicians:\n\nInclusion criteria\n\n\\- Any physician treating a patient for one of the five long-term illnesses listed above is eligible to refer the patient to a pharmacy providing myCare start.\n\nPharmacies:\n\nInclusion criteria:\n\n* Have to be enrolled into the myCare Start service and comply to the requirements of the pharmacy quality system management of having access to a private consultation room or area\n* Must agree to participate in the research study, including the recruitment of control patients and the delivery of the myCare Start service to intervention patients.",{"count":668,"type":20},1600,[62],"In Phase B, the aim is to evaluate the myCare Start service in routine care within the ambulatory primary care medicine and community pharmacy setting in Switzerland. A Type II hybrid effectiveness-implementation study will be conducted to evaluate the effectiveness (improvement in adherence), cost-effectiveness and implementation of the service. This evaluation will allow us to build the necessary contextual relevant evidence base to support sustainable funding of the service in the long term.",[672,673,497,674,675,676,677],"Cardio-vascular Disease","Depression Disorders","COPD","Asthma Bronchiale","Hyperlipidaemia","Medication Initiation for Long-term Conditions",[679,680,681,682,683,684,685,686,687,688,689],"patient adherence","medication adherence","medication initiation","long-term treatment","implementation science","interprofessional collaboration","outpatient care","community pharmacy","general practitioner","cost-effectiveness","medication adherence support programme","2025-06-16",{"date":692,"type":42},"2025-06-25",{"date":694,"type":20},"2025-06",{"date":432,"type":20},{"name":697,"class":49},"University of Geneva, Switzerland"]