[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"microvascular-coronary-dysfunction\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:microvascular-coronary-dysfunction":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,78],{"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":26,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100253752","wise-cvd---continuation-wise-hfpef-100253752",false,"NCT02582021","WISE CVD - Continuation (WISE HFpEF)","Women's Ischemia Syndrome Evaluation (WISE) - Coronary Microvascular Dysfunction (CMD) and Heart Failure With Preserved Ejection Fraction (HFpEF)","Inclusion Criteria:\n\nFor the new cohort n=120 women undergoing coronary angiography:\n\n* Symptomatic angina or anginal equivalent\n* Age ≥ 18\n* Participant is willing to give written informed consent\n\nFor the cohort n=100 women and men hospitalized for HFpEF (defined by ESC guidelines):\n\n* Age ≥ 18\n* Signs and symptoms of heart failure\n* Preserved ejection fraction, left ventricular ejection fraction (LVEF) ≥45% prior to study entry.\n* Structural evidence of cardiovascular abnormalities: elevated brain naturetic peptide, evidence of abnormal filling or relaxation, left ventricular hypertrophy, or an increased left atrial size\n* Evidence of elevated filling pressures: LVEDP or PCWP at rest \\> 15 mmHg and\u002For with exercise ≥25 mmHg, exercise E\u002Fe' \\>13, elevated BNP, or use of diuretic\n* Participant is willing to give written informed consent\n\nExclusion Criteria:\n\nFor the new cohort n=120 women undergoing invasive coronary angiography:\n\n* Obstructive CAD ≥ 50% luminal diameter stenosis in ≥ 1 epicardial coronary artery\n* STEMI within 3-7 days post MI, or Acute coronary syndrome\u002FNSTEMI with with symptoms or signs of acute myocardial ischemia within the last 12 to 24 hours prior to the research procedure, as outlined in ACC\u002FAHA guidelines.\n* Primary valvular heart disease clearly indicating the need for valve repair or replacement\n* Patients with concurrent cardiogenic shock or requiring inotropic or intra-aortic balloon support or LVEF\\\u003C45%\n* Prior or planned percutaneous coronary intervention or coronary artery bypass grafting for obstructive coronary atherosclerosis\n* Non-cardiac illness with a life expectancy \\\u003C four years\n* Unable to give informed consent\n* Chest pain which has an alternative non-ischemic etiology, i.e. pericarditis, pulmonary embolism, pleurisy, pneumonia, esophageal spasm, etc.\n* Contraindications to CMRI, such as internal cardiac defibrillator, untreatable claustrophobia or known angioedema\n* Contraindications to adenosine or regadenoson including severe COPD and asthma\n* End stage renal or liver disease\n* Women with intermediate coronary stenoses (\\>20% but \\\u003C50% luminal diameter stenosis assessed visually at the time of angiography) will undergo clinically indicated fractional flow reserve (FFR) based on the judgment of the operator; those determined to have flow-obstructing stenosis will be excluded.\n* Documented allergy to gadolinium\n\nFor the new cohort n=100 women and men hospitalized for HFpEF:\n\n* Current LVEF \\\u003C45%\n* STEMI within 3-7 days post MI, or Acute coronary syndrome\u002FNSTEMI with with symptoms or signs of acute myocardial ischemia within the last 12 to 24 hours prior to the research procedure, as outlined in ACC\u002FAHA guidelines.\n* Acute coronary syndrome (defined by ACC\u002FAHA guidelines, including MI) within 3 months of entry. Patients who have had an MI or other event within the 6 months prior to entry unless an echo measurement performed after the event confirms a LVEF ≥45%.\n* Primary valvular heart disease (moderate regurgitation or\\>mild stenosis), primary cardiomyopathies (hypertrophic, infiltrative or restrictive), constrictive pericarditis, high-output heart failure, and right ventricular myopathies)\n* Patients with concurrent cardiogenic shock or requiring inotropic or intra-aortic balloon support or current acute decompensated HF requiring therapy including due to trauma, infection.\n* Alternative reason for shortness of breath such as: significant pulmonary disease or severe COPD, hemoglobin (Hgb) \\\u003C10 g\u002Fdl, or body mass index (BMI) \\> 40 kg\u002Fm2.\n* Systolic blood pressure (SBP) ≥ 180 mmHg at entry, or SBP \\>150 mmHg and \\\u003C180 mmHg at entry unless the patient is receiving 3 or more antihypertensive drugs.\n* Prior or planned percutaneous coronary intervention or coronary artery bypass grafting for obstructive coronary atherosclerosis\n* Non-cardiac illness with a life expectancy \\\u003C four years\n* Unable to give informed consent\n* Contraindications to CMRI, such as internal cardiac defibrillator, untreatable claustrophobia or known angioedema\n* Contraindications to adenosine or regadenoson including severe COPD and asthma.\n* Obstructive stenoses (≥50% luminal diameter stenosis assessed visually at the time of research CTA) will be excluded from further analyses. Subjects with obstructive or borderline obstructive coronary CTA stenoses will be referred to their clinicians for further clinical care and clinical decision making. End stage renal or liver disease","ALL","18 Years",{"count":19,"type":20},220,"ESTIMATED","OBSERVATIONAL","The Women's Ischemia Study Evaluation (WISE), a cohort study of over 1000 women, has made many contributions to the understanding of cardiovascular disease. A milestone acknowledged in the 2011 AHA Herrick Lecture is the role of Coronary Microvascular Dysfunction (CMD) in women with symptoms\u002Fsigns of ischemia without obstructive coronary artery disease (CAD). While in 1996, CMD was considered \"an imaging artifact\", in 2013, it is a widely accepted as a pathophysiologic process requiring systematic cohesive scientific pursuit. CMD is prevalent, associated with adverse clinical outcomes, poor quality of life and healthcare costs rivaling obstructive CAD. There are 2-3 million US women with CMD, and 100,000 new cases projected annually placing CMD prevalence, morbidity and costs higher than all female reproductive cancers combined.\n\nAmong women with ischemia, preserved ejection fraction and no obstructive CAD, it has been observed that there are relatively more new onset heart failure (HF) hospitalizations than nonfatal myocardial infarction (MI). It has been hypothesized that CMD contributes to left ventricular (LV) diastolic dysfunction and subsequent heart failure with preserved ejection fraction (HFpEF). Preliminary data further suggests that left ventricular diastolic dysfunction is linked to CMD via a mechanism of augmentation and\u002For perpetuation by cardiomyocyte fat accumulation. HFpEF is prevalent in women and older men, but poorly understood. Mechanistic understanding is critical to HFpEF intervention and guideline development.\n\nThe study hypotheses are as follows:\n\n1. Risk factor conditions (hypertension, dyslipidemia, dysglycemia, loss of estrogen) promote an inflammatory and pro-oxidative state making the microvasculature vulnerable;\n2. Vulnerable coronary microvasculature becomes dysregulated (sympathetic nervous system activation, endothelial dysfunction, changes in vascular smooth muscle activation, spasm) causing repeated episodes of transient ischemia;\n3. Repeated ischemia-reperfusion episodes facilitate preconditioning with preservation of cardiomyocyte contractile and microvascular function against ischemic injury;\n4. Ischemia-reperfusion and preconditioning lead to cardiomyocyte fat accumulation and relaxation impairment resulting in diastolic dysfunction and heart failure with preserved ejection fraction (HFpEF).",[24,25],"Microvascular Coronary Dysfunction","Cardiovascular Disease",[27,28,29,30],"Microvascular Coronary Dysfunction (MCD)","Magnetic resonance imaging (MRI)","Coronary angiography","Coronary Vascular Dysfunction (CVD)","RECRUITING","2025-07-23",{"date":34,"type":35},"2025-07-24","ACTUAL",{"date":37,"type":4},"2015-11",{"date":39,"type":20},"2030-02",{"name":41,"class":42},"Cedars-Sinai Medical Center","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":60,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"100568489","microvascular-coronary-rehabilitation-for-improving-treatment---feasibility-study-100568489","NCT06681896","Microvascular Coronary Rehabilitation For Improving Treatment - Feasibility Study","MICROFIT","Inclusion Criteria:\n\n* Age ≥18\n* Angina or angina equivalent symptoms\n* Unobstructed coronary arteries at the time of coronary angiogram. This will be defined as plaque causing \\\u003C40% epicardial vessel stenosis or 40-90% with a fractional flow reserve (FFR) ≥0.8\n* Evidence of microvascular dysfunction on ICA (CFR \\\u003C2.5 and\u002For AchFR \\\u003C1.5)\n\nExclusion Criteria:\n\n* New York Heart Association class III\u002FIV heart failure\n* Severe left ventricular impairment (ejection fraction≤35%)\n* Severe heart valve disease\n* Significant cardiomyopathy (as assessed by a cardiologist)\n* Severe hypertension (defined as blood pressure \\>180\u002F120mmHg (despite three anti-hypertensive agents)\n* Uncontrolled arrhythmia\n* A history of aortic dissection, recent (\\\u003C6 months) acute pulmonary embolus, deep vein thrombosis, stroke or transient ischaemic attack, severe autonomic or peripheral neuropathy, acute systemic illness or fever, severe acute or chronic renal failure, severe pulmonary fibrosis or interstitial lung disease (in line with other trials investigating HIIT exercise)\n* Pregnancy or breastfeeding (at any point during the study. Patients becoming pregnant during the study will be asked to withdraw due to additional radiation exposure and risks from HIIT)\n* Physical inability to participate in exercise\n* Significant claustrophobia or metallic implants which would limit MRI imaging\n* Intolerance to regadenoson testing (high degree atrioventricular block, severe asthma or airways disease)\n* Current participation in another intervention-based trial\n* Inability to fully understand the verbal and written descriptions of the study and instructions provided during the study duration.",{"count":52,"type":20},40,"INTERVENTIONAL",[55],"NA","The goal of this clinical trial is to assess the feasibility of undertaking a randomized controlled trial assessing the impact of a personalised, intense cardiac rehabilitation programme involving high intensity interval exercise (HIIT) and dietary advice (termed MICROFIT) on symptom burden in patients with microvascular coronary dysfunction.\n\nThe main questions it aims to answer are:\n\n1. Feasibility of undertaking randomised controlled trial of MICROFIT in patients with coronary microvascular dysfunction (recruitment rates, retention and adherence, acceptability of MICROFIT and participants' and practitioners' experiences of trial participation)\n2. Preliminary data on the effect that MICROFIT has on angina symptoms in patients with microvascular coronary dysfunction, as measured by Seattle Angina Questionnaire\n3. Preliminary data on the fidelity and clinical efficacy of MICROFIT\n\nParticipants will be randomized to either MICROFIT + Usual Care, or Usual Care group.\n\nParticipants in both arms of the trial will:\n\n* Undergo a series of investigations, including cardiopulmonary exercise test (CPET), dual xray absorptiometry (DEXA), echocardiogram, cardiac MRI scan, blood tests, at the start of the trial and again after 6 months\n* Measure their living activity by using an activity tracker (GeneActiv) as well as a photographic diet diary for a week at the start of the trial and again after 6 months\n* Complete a series of questionnaires to assess angina symptom burden, mental health and quality of life, at the start of the trial and again after 6 months.\n\nParticipants in the intervention arm of the study will:\n\n1. Undergo MICROFIT intervention. MICROFIT includes a combination of exercise and diet management sessions over 24 weeks. It involves:\n\n   * 1:1 high-intensity interval training ('HIIT') sessions with a personal trainer and guidance on exercise sessions to be performed at home\n   * 1:1 sessions with a dietician to support them with improvements in diet.\n2. Visit clinic on two additional occassions during the trial to discuss their progress with a cardiologist\n3. Undergo an interview at the end of the study to discuss their experiences of participation in the study\n4. Receive a debrief on their investigation results and progress made at the end of their study\n\nParticipants in the Usual Care arm of the study will:\n\n1. Receive standard Usual Care advice regarding lifestyle changes and targeted medical therapy offered to patients with coronary microvascular dysfunction.\n2. Receive a debrief on their investigation results and progress made at the end of their study\n3. Undergo a 'taster' session with the personal trainer to discover what the intervention involves.",[24,58,59],"Microvascular Angina","Coronary Microvascular Dysfunction (CMD)",[61,62,63,64,65,66,67],"coronary microvascular dysfunction","HIIT","high intensity interval exercise training","exercise training","dietary rehabilitation","lifestyle advice","microvascular angina","2025-06-17",{"date":70,"type":35},"2025-06-18",{"date":72,"type":35},"2024-11-12",{"date":74,"type":20},"2027-01-01",{"name":76,"class":42},"Royal United Hospitals Bath NHS Foundation Trust",2,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":85,"sex":86,"minAge":17,"maxAge":87,"enrollmentInfo":88,"targetDuration":4,"studyType":53,"phases":90,"briefSummary":91,"conditions":92,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":43},"100232284","development-of-a-novel-stress-testing-protocol-to-define-the-relationship-between-coronary-microvascular-dysfunction-and-diastology-in-women-with-angina-but-no-evidence-of-obstructive-coronary-artery-disease-100232284","NCT02301663","Development of a Novel Stress Testing Protocol to Define the Relationship Between Coronary Microvascular Dysfunction and Diastology in Women With Angina But No Evidence of Obstructive Coronary Artery Disease","DEVELOPMENT OF A NOVEL STRESS TESTING PROTOCOL TO DEFINE THE RELATIONSHIP BETWEEN CORONARY MICROVASCULAR DYSFUNCTION AND DIASTOLOGY IN WOMEN WITH ANGINA BUT NO EVIDENCE OF OBSTRUCTIVE CORONARY ARTERY DISEASE","Inclusion Criteria:\n\n1. Fully understanding and willing to undergo study procedures\n2. Male or Female greater than or equal to 18 years of age\n3. Understanding and willing to sign consent form.\n\nExclusion Criteria:\n\n1. History of cardiovascular, pulmonary, or neurological disease\n2. Hypertension (sitting blood pressure \\>140\u002F90 mmHg, with measurements recorded on at least 2 occasions)\n3. Diabetes\n4. Unable to give informed consent;\n5. Contra-indication to CMRI testing, including claustrophobia and metallic implants\n6. Adherence or retention issues;\n7. Women who are pregnant.\n8. Allergy to animal dander.",true,"FEMALE","60 Years",{"count":89,"type":20},30,[55],"Microvascular coronary dysfunction (MCD) (abnormities in small blood vessels\u002Farteries in heart) with symptoms of persistent chest pain, primarily impacts women. There are an estimated 2-3 million women in the US with MCD and about 100,000 new cases annually. Recent data from our research group suggests that coronary microvascular disease impairs the way the heart relaxes. This pilot study will attempt to exacerbate this phenotype in an effort to better understand the pathophysiology of the disease. The investigators will recruit 30 volunteers total (10 healthy calibration subjects, 10 women with microvascular disease, and 10 age-match women for the group with microvascular disease). Subjects will undergo a series of \"stress\" maneuvers in conjunction with advanced cardiac magnetic resonance imaging.",[24],"2023-08-31",{"date":95,"type":35},"2023-09-01",{"date":97,"type":4},"2014-11",{"date":99,"type":20},"2030-12",{"name":41,"class":42}]