[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cardiac-diseases\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cardiac-diseases":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,49,89,118,150,180],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":18,"targetDuration":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100641010","an-international-multicenter-multivendor-evaluation-of-the-free-running-framework-for-cardiac-function-100641010",false,"NCT07613398","An International Multicenter, Multivendor Evaluation of the Free-Running Framework for Cardiac Function","Assessment and Validation of the Established Free-Running Framework for Cardiac Function by Magnetic Resonance Imaging (FAST-CMR): An International Multi-Center, Multi-Vendor Study at 1.5T","FAST-CMR","Inclusion Criteria:\n\n* Diagnosed with cardiac disease of any complexity and scheduled for a clinical cardiac MRI on a clinical 1.5T MRI scanner\n* Able to understand and provide written informed consent or, for minors, ability to provide assent with written consent from a parent\u002Flegal representative, per local law and site policy prior to the study\n* Ability to undergo MRI without contraindications\n* Agrees to be informed in the event of incidental findings\n\nExclusion Criteria:\n\n* Severe claustrophobia preventing MRI completion\n* Presence of non-MRI compatible implants (e.g., pacemakers, certain metallic implants)\n* Contraindications to the intravenous contrast agent\n* Movement disorders or inability to remain still during the scan","ALL",{"count":19,"type":20},300,"ESTIMATED","1 Day","OBSERVATIONAL","This project aims to evaluate a new cardiac MRI technique called the Free-Running Framework (FRF), which could simplify and accelerate the process of acquiring cardiac images. The investigators want to verify whether this method can provide functional heart measurements comparable to those obtained with traditional methods. More specifically, the goal of the study is to compare the measurements obtained with FRF to those obtained with standard sequences, to ensure they match and that this new approach can be reliably used in clinical practice. The FRF technique works differently from standard cardiac MRI. In standard exams, patients are asked to hold their breath several times and small electrodes (ECG) are used to monitor the heartbeat during the scan. These steps are needed to get clearer images of the heart as it moves. With FRF, these steps are no longer necessary: the scan is performed while patients' breath normally and without ECG monitoring. In addition, standard MRI takes multiple 2D slices of the heart, one after another. The FRF method instead captures a 3D image of the entire heart in one go, which can improve the consistency of the exam and reduce errors when doctors analyze the images later. This is all possible because the FRF method records data continuously and then organizes the images afterward based on how participants heart and breathing were moving during the exam. This helps the imager to get clear images of the heart, even without breath-holding or ECG monitoring. This project is aimed at individuals with heart disease who require cardiac MRI exams to monitor their health status (age ≥ 18 years) and are able to clearly understand the instructions provided by the research team. The investigators have already conducted small-scale technical and feasibility studies using FRF. These studies have shown that FRF is easy to use, faster than traditional methods, and provides image quality comparable to standard imaging techniques. The investigators now wish to evaluate its use in a clinical setting. More specifically, the investigators need to verify that FRF provides the same essential diagnostic information as standard techniques, so that it can be reliably used in future patient care. A maximum of 300 participants will be included in the investigation of this MRI technique between 2026 and 2031. This is a multi-center study, conducted internationally across 18 centers.\n\nThis project is being carried out in compliance with Swiss legislation. The investigators follow all internationally recognized guidelines. The competent ethics committee has reviewed and approved this project.",[25,26],"Congenital Heart Diseases","Cardiac Diseases",[28,29,30,31,32,33,34,35],"Free-running","Cine magnetic resonance imaging","Ventricular function","Multicenter","Multivendor","FISS (Fast- Interrupted Steady-State)","Compressed sensing","Pragmatic clinical study","NOT_YET_RECRUITING","2026-05-21",{"date":39,"type":40},"2026-05-29","ACTUAL",{"date":42,"type":20},"2026-06",{"date":44,"type":20},"2030-09",{"name":46,"class":47},"Matthias Stuber","OTHER",20,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":71,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":88},"100443196","respiratory-muscles-and-work-of-breathing-in-children-100443196","NCT05051254","Respiratory Muscles and Work of Breathing in Children","WOB&MR_Ped","Inclusion Criteria:\n\n* Patients aged less than 18 years old with primary or secondary impairment of respiratory muscles and followed at Necker Hospital\n* Patients under spontaneous breathing or noninvasive or invasive mechanical ventilation\n* Written informed consent\n\nExclusion Criteria:\n\n* No social insurance\n* Significant psychomotor retardation\n* Absence of cooperation\n* Significant agitation\n* Hemodynamic instability\n* Acute condition or temporary drug treatments that may interfere with the results of the respiratory muscle explorations","0 Years","17 Years",{"count":59,"type":20},550,"INTERVENTIONAL",[62],"NA","Respiratory muscle testing allows a quantitative assessment of inspiratory and expiratory muscles in children of any age with primary or secondary respiratory muscle impairment, in order to better understand the pathophysiology of respiratory impairment and guide therapeutic management. The use of an invasive technique (esogastric probe) makes it possible to specifically explore the diaphragm, the accessory inspiratory muscles and the expiratory muscles in order to detect dysfunction or paralysis of these muscles, and to estimate the work of breathing in order to better guide the respiratory management.\n\nThe primary objective of the study is to evaluate the respiratory effort in children with primary or secondary impairment of the respiratory muscles during spontaneous breathing or during mechanical ventilation.",[65,66,67,26,68,69,70],"Neuromuscular Diseases","Congenital Diaphragmatic Hernia","Lung Diseases","Scoliosis","Diaphragmatic Impairment","Respiratory Muscle Impairment",[72,73,74,75,76,77],"Respiratory muscle testing","Respiratory muscle strength","Work of breathing","Esogastric pressures","Diaphragmatic dysfunction","Diaphragmatic paralysis","RECRUITING","2026-03-30",{"date":81,"type":40},"2026-04-03",{"date":83,"type":40},"2022-01-19",{"date":85,"type":20},"2028-01",{"name":87,"class":47},"Assistance Publique - Hôpitaux de Paris",1,{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":17,"minAge":97,"maxAge":4,"enrollmentInfo":98,"targetDuration":4,"studyType":60,"phases":100,"briefSummary":101,"conditions":102,"keywords":105,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":4},"100604535","benefits-of-no-fasting-compared-to-fasting-prior-to-elective-cardiac-catheterization-a-single-center-randomized-controlled-trial-100604535","NCT07150780","Benefits of no Fasting Compared to Fasting Prior to Elective Cardiac Catheterization: A Single-center Randomized-controlled Trial","Benefits of no FASTing Prior to Elective Cardiac CATHeterization (FAST CATH): A Single-center Randomized-controlled Trial Comparing a Non-fasting Pre-procedure Approach to the Standard of Care in Adults Undergoing Elective Cardiac Catheterization With Moderate Sedation","FAST CATH","Inclusion Criteria:\n\n* Willing to comply with all study procedures and remain in contact with the study team to complete study assessments for the duration of the study\n* Scheduled for an elective (non-urgent) cardiac catheterization\n* Age of 18 or older at the time of consent\n\nExclusion Criteria:\n\n* Adults unable to consent\n* Pregnant women\n* Incarceration\n* Non-English-speaking patients\n* Inability to eat by mouth\n* Patients requiring general anesthesia for cardiac catheterization\n* Inability to fast for at least 6 hours\n* Personal history of pulmonary aspiration, or other known cardiopulmonary anesthetic complication(s)\n* Urgent cardiac catheterization\n* Inability or unwillingness to comply with all study procedures\n* Previously enrolled in this study (patients may not be enrolled more than once for subsequent procedures)","18 Years",{"count":99,"type":20},2000,[62],"More than one million cardiac catheterizations (CCs) are performed annually in the United States and the majority are elective. Current guidelines recommend no fasting prior to elective CC, however recent studies suggest that eating and drinking as desired prior to elective CCs involving moderate sedation is safe.\n\nThis project will study the potential benefits of allowing patients to eat before elective CCs. Participants will be randomly divided into two groups. One group will receive pre-op instructions to fast, and the other group will be allowed to eat and drink as desired prior to their CC. Researchers will compare these groups with regards to patient satisfaction and respiratory complications.",[103,104,26],"Coronary Artery Disease","Cardiac Catheterization",[106,107,108],"Cardiac catheterization","Fasting","Patient Satisfaction","2025-08-25",{"date":111,"type":40},"2025-09-02",{"date":113,"type":20},"2025-09-10",{"date":115,"type":20},"2028-02-10",{"name":117,"class":47},"Munson Medical Center",{"id":119,"slug":120,"hasResults":11,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":4,"eligibilityCriteria":124,"healthyVolunteers":11,"sex":17,"minAge":97,"maxAge":4,"enrollmentInfo":125,"targetDuration":4,"studyType":60,"phases":127,"briefSummary":129,"conditions":130,"keywords":131,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":5},"100578771","phase-3-safety-and-efficacy-evaluation-of-nh002-as-a-contrast-agent-in-subjects-undergoing-cardiac-echocardiography-100578771","NCT06815627","Safety and Efficacy Evaluation of NH002 as a Contrast Agent in Subjects Undergoing Cardiac Echocardiography","A Prospective, Multicenter, Phase III Clinical Evaluation of the Safety and Efficacy of NH002 as a Contrast Agent in Subjects Undergoing Cardiac Echocardiography","Inclusion Criteria:\n\n1. 18 years of age or older\n2. Ability to understand and the willingness to provide written informed consent\n3. Having or suspected of having cardiac disease\n4. Undergone a transthoracic echo within 30 days prior to NH002 dose administration, resulting in suboptimal LVEBD, as defined by 2 or more segments of 6 segments of the ventricular border that cannot be visualized reliably in any of the standard apical 4-, 2-, and 3-chamber views during the resting non-contrast ultrasound examination\n\nExclusion Criteria:\n\nSubjects will be excluded from the study if one or more of the following exclusion criteria are applicable:\n\n1. Any evidence of other severe or unstable cardiopulmonary and\u002For systemic hemodynamic conditions deemed unsuitable for the study by the investigator(s) prior to NH002 dose administration, including, but not limited to:\n\n   1. ongoing or recent acute coronary syndrome within 6 months.\n   2. uncontrolled serious ventricular arrhythmias.\n   3. decompensated or inadequately controlled congestive heart failure (New York Heart Association Class IV).\n   4. atrial fibrillation or current uncontrolled cardiac arrhythmias causing symptoms or hemodynamic compromise.\n   5. uncontrolled hypertension (i.e., resting systolic blood pressure \\>200 mmHg or diastolic blood pressure \\>110 mmHg or arterial hypotension \\[defined as systolic blood pressure ≤ 90 mmHg\\]).\n   6. acute aortic dissection.\n2. Known or suspected hypersensitivity to one or more of the ingredients of NH002, perflutren, Definity®, or other echocardiographic contrast agents\n3. Known or suspected hypersensitivity to polyethylene glycol, prior reactions to common polyethylene glycol-containing products such as colonoscopy bowel preparations, and certain laxatives (e.g., Miralax)\n4. Received an investigational compound within 30 days before enrolling in the study\n5. Received any contrast agent either intravascularly or orally within 48 hours prior to NH002 dose administration\n6. Pregnant or lactating female. Exclude the possibility of pregnancy:\n\n   1. testing on-site at the institution (serum or urine β-human chorionic gonadotropin) within 24 hours prior to the start of NH002 dose administration, and\n   2. history of using an adequate and medically approved method of contraception to avoid pregnancy for at least 1 month prior to NH002 dose administration and willing to continue using the same method for the duration of the study, or\n   3. surgical history (e.g., tubal ligation or hysterectomy), or\n   4. postmenopausal with a minimum of 1 year without menses.\n7. Serious medical or psychiatric illness\u002Fcondition likely, in the judgment of the investigator, to interfere with compliance to protocol treatment\u002Fresearch",{"count":126,"type":20},150,[128],"PHASE3","This is a Phase 3, prospective, open-label, multicenter study to assess the efficacy of NH002-enhanced echocardiography in subjects with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the left ventricular endocardial border delineation compared with unenhanced echocardiography. The study also aims to investigate the safety and tolerability of NH002.",[26],[132,133,134,135,136,137,138,139],"Echo","Echocardiogram","Cardiac ultrasound","suboptimal","contrast agent","enhancing agent","LVO","LVEBD","2025-08-19",{"date":142,"type":40},"2025-08-26",{"date":144,"type":40},"2025-03-18",{"date":146,"type":20},"2027-02",{"name":148,"class":149},"Trust Bio-sonics, Inc.","INDUSTRY",{"id":151,"slug":152,"hasResults":11,"nctId":153,"briefTitle":154,"officialTitle":154,"acronym":155,"eligibilityCriteria":156,"healthyVolunteers":11,"sex":17,"minAge":97,"maxAge":4,"enrollmentInfo":157,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":159,"conditions":160,"keywords":167,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":88},"100576524","a-monitoring-system-based-on-the-multifactorial-dynamic-perfusion-index-to-predict-and-prevent-the-onset-of-postoperative-acute-kidney-injury-after-cardiac-surgery-based-on-a-dynamic-collection-of-hemodynamic-and-clinical-parameters-during-cardiopulmonary-bypass-100576524","NCT06786416","A Monitoring System Based on the Multifactorial Dynamic Perfusion Index to Predict and Prevent the Onset of Postoperative Acute Kidney Injury After Cardiac Surgery, Based on a Dynamic Collection of Hemodynamic and Clinical Parameters During Cardiopulmonary Bypass","PEQUOD 2","Inclusion Criteria:\n\n* patients undergoing cardiac surgery with cardiopulmonary bypass\n* patients \\>18 years for WP1 and WP3; patients \\\u003C6 years and weight \\\u003C20 kg for WP2\n* willingness to participate and sign the informed consent\n\nExclusion Criteria:\n\n* chronic renal failure on dyalisis for WP1 and WP3\n* emergency surgery for all WP\n* refusal to partecipate",{"count":158,"type":20},800,"This project is based on a predictive alghorithm (Multifactorial Dynamic Perfusion Index-MDPI) already published and covered by a patent. The MDPI is based on a dynamic collection of 7 different variables during cardiopulmonary bypass (CPB) and provides a probability index for postoperative acute kidney injury. The study design is a multicenter observational prospective trial developed through 3 work packages, addressing (1) external validation of the MDPI in a series of 800 adult cardiac surgery patients collected in 2 Institutions (2) development of a novel MDPI to be applied in infants \\\u003C 20 kg undergoing cardiac surgery (200 patients) and (3) verification of of other possible outcomes that may be predicted by the MDPI. Since many of the predictive variables are modifiable by the perfusionist\u002Fanesthesiologist during CPB, it is a tool that allows therapeutic manouvres. Ultimately, the MDPI will be incorporated in a dedicated monitor to provide an on-line \"flight control\" during CPB. Work package 1 will be performed at Units 1 and 2; the parameters composing the MDPI will be collected using the existing CPB monitors that routinely measure the hematocrit, the oxygen delivery, the time of exposure to a pre-defined critical oxygen delivery, the mean arterial pressure, and the CPB duration. Blood lactates and transfusions will be manually inputed. The MDPI will be calculated off-line and tested for association and predictivity (discrimination and calibration) with respect to postoperative AKI defined according to the K-DIGO classification. Workpackage 2 is dedicated to infants, with the purpose of developing an MDPI dedicated to low-weight infants (I-MDPI). This will be develop in Unit 1 that performs congenital heart surgery. The same variables of the MDPI will be collected, plus additional variables specific for infants (blood to prime the oxygenator, plasma for the same purpose; venous oxygen saturation, and others). The variables being independently associated with AKI will enter a logistic regression equation that will be the basis for the I-MDPI. Workpackage 3 considers that AKI is associated with a prolonged mechanical ventilation time, prolonged stay in the intensive care unit and in the hospital; and mortality. Therefore, the MDPI may be predictive of other postoperative complications, apart from AKI, and even of mortality. Some of the factors included in the MDPI may directly (low hematocrit) or indirectly (prolonged CPB duration, excessive hemodilution, low mean arterial pressure) affect the hemostatic system and\u002For trigger packed red cells transfusions. Additionally, CPB itself is a determinant of a coagulophatic state with associated postoperative bleeding which, in turns, increases the mortality. The specific aim 3 is to confirm the hypothesis that the MDPI may be predictive of one or more of this non-AKI postoperative complications and of 30-days mortality. In the same series of work package and aim 1, these complications will be collected and the MDPI tested for predictive ability of each one of these complications and 30-days mortality. At present, the MDPI can only be calculated off-line, and this greatly limits its applicability. The last step of the aim 3 is based on the involvement of software experts and partnership with companies interested in including the MDPI into their existing monitors; as such, the MDPI patent would be given under licence of the existing patent owned by the IRCCS Policlinico San Donato.",[26,161,162,163,164,165,166],"Cardio-pulmonary Bypass","Acute Kidney Injury","Adult Cardiac Surgery","Infants Cardiac Surgery","Extracorporeal Circulation; Complications","Perfusion; Complications",[168,169,170],"cardiopulmonary bypass","acute kidney injury","cardiac surgery","2025-01-15",{"date":173,"type":40},"2025-01-22",{"date":175,"type":40},"2024-09-18",{"date":177,"type":20},"2026-09",{"name":179,"class":47},"IRCCS Policlinico S. Donato",{"id":181,"slug":182,"hasResults":11,"nctId":183,"briefTitle":184,"officialTitle":185,"acronym":4,"eligibilityCriteria":186,"healthyVolunteers":11,"sex":17,"minAge":187,"maxAge":4,"enrollmentInfo":188,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":190,"conditions":191,"keywords":192,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":4},"100570428","health-literacy-as-a-mediator-between-gender-illness-identity-and-self-efficacy-100570428","NCT06707116","Health Literacy As a Mediator Between Gender, Illness Identity, and Self-Efficacy","The Mediating Role of Health Literacy in the Relationship Between Gender Differences, Illness Identity, and Self-Efficacy Patients with Cardiac Diseases: a Structural Equation Model","Inclusion Criteria:\n\n* Adults aged 30 years or older.\n* Diagnosed with a cardiac disease (e.g., heart failure, coronary artery disease, arrhythmia).\n* Able to provide informed consent.\n* Sufficient health literacy to complete surveys in the study language.\n* Currently under regular medical care for their cardiac condition.\n\nExclusion Criteria:\n\n* Individuals with a cognitive impairment or diagnosis of dementia that could interfere with survey participation.\n* Patients with co-morbid terminal illnesses that significantly impact life expectancy (e.g., advanced cancer).","30 Years",{"count":189,"type":20},100,"The goal of this observational study is to understand the role of health literacy in shaping the relationship between gender differences, illness identity, and self-efficacy in geriatric patients with cardiac diseases. The main question it aims to answer is:\n\nDoes health literacy mediate the relationship between gender, illness identity, and self-efficacy in elderly cardiac patients?\n\nParticipants with diagnosed cardiac conditions, will complete online surveys assessing their health literacy, illness identity, and self-efficacy over a one-year period. Structural Equation Modeling (SEM) will be used to analyze the relationships among these variables.",[26],[193,194],"Health Literacy","Gender Differences","2024-11-27",{"date":197,"type":40},"2024-11-29",{"date":199,"type":20},"2025-01-01",{"date":201,"type":20},"2025-05-01",{"name":203,"class":47},"Cairo University"]