[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100572611":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":10,"centralContacts":19,"locations":29,"responsibleParty":48,"collaborators":52,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":63,"maxAge":10,"enrollmentInfo":64,"targetDuration":67,"studyType":68,"phases":10,"briefSummary":69,"conditions":70,"keywords":75,"overallStatus":32,"whyStopped":10,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Karolinska Institutet","OTHER",[8],{"label":9,"type":10,"description":10,"interventionNames":11},"Univentricle heart, operated with TCPC (total cavo pulmonary connection)",null,[12],"Diagnostic Test: Cardiac magnetic resonance stress-perfusion",[14],{"type":15,"name":16,"description":17,"armGroupLabels":18,"otherNames":10},"DIAGNOSTIC_TEST","Cardiac magnetic resonance stress-perfusion","Included patients will be examined at the Karolinska University Hospital in a 1.5T Siemens Sola magnetic resonance camera at rest and during adenosine stress with specific CMR sequences (adenosine stress-perfusion, myocardial velocities, and tissue characterization) for non-invasive determination of macro- and microvascular dysfunction, global myocardial function, pulmonary artery pressure and scarring of the myocardium.\n\nAdenosine or Regadenoson will be used as stress medication which is according to clinical routine. Adenosine will be infused over approximately 5 minutes (110-140 μg \u002F kg\u002Fmin), Regadenoson (5 ml) will be a 10-second injection (400 μg single dosage). Intravenous gadolinium-based contrast agents will be administered, Gadovist (1 mmol\u002Fml, gadobuterol), 0.15 mmol\u002Fkg during stress and rest.",[9],[20,25],{"name":21,"role":22,"phone":23,"phoneExt":10,"email":24},"Peder Sorensson, MD, Associate professor","CONTACT","+46 731 400059","peder.sorensson@ki.se",{"name":26,"role":22,"phone":10,"phoneExt":27,"email":28},"Ayse-Gul Ozturk, MD","+46 72 578 02","ayse-gul.ozturk@ki.se",[30],{"facility":31,"status":32,"city":33,"state":10,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Karolinska University Hospital","RECRUITING","Stockholm","17176","Sweden","SE",{"type":38,"coordinates":39},"Point",[40,41],18.06871,59.32938,{"lat":41,"lon":40},[44,45,47],{"name":21,"role":22,"phone":23,"phoneExt":10,"email":24},{"name":26,"role":22,"phone":46,"phoneExt":10,"email":28},"+46 72 578 02 72",{"name":21,"role":22,"phone":10,"phoneExt":10,"email":10},{"type":49,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Peder Sörensson","Senior Consultant in Cardiology",[53],{"name":31,"class":6},"100572611","cardiac-magnetic-resonance-stress-perfusion-study-in-patinets-with-fontan-circulation-100572611",false,"NCT06735521","Cardiac Magnetic Resonance Stress-perfusion Study in Patinets with Fontan Circulation","Att Överleva Och Leva Som Vuxen Med Enkammarhjärta I Sverige","CMR_TCPC","Inclusion Criteria:\n\n* Patients who had undergone total cavo-pulmonary connection (TCPC) surgery resulting in Fontan circulation.\n* NYHA (New York Heart Assosiation) class I-II.\n* Understanding the study information (signed informed consent).\n* \\>18 years old.\n\nExclusion Criteria:\n\n* Device therapy (pacemaker, ICD).\n* Failing Fontan (NYHA III-IV).\n* Kidney failure (GFR\\\u003C30ml\u002Fh).\n* Arrythmia (atrial fibrillation).\n* Pregnancy.","ALL","18 Years",{"count":65,"type":66},30,"ESTIMATED","1 Year","OBSERVATIONAL","Univentricular heart (UVH) is a severe congenital heart disease. Accurate advanced non-invasive diagnostic methods is limited. Cardiovascular magnetic resonance (CMR) imaging has evolved as a particularly useful tool for the study of patients with adult congenital heart disease (ACHD) considering its ability to determine detailed anatomy and detect early cardiac dysfunction without the need for radiation exposure. Most of contemporary treatment recommendations are based on consensus opinions\u002Fdocuments and small studies from local, or national registries. Improved knowledge is needed in all these areas to facilitate clinical decisions regarding treatment, monitoring and follow-up.\n\nThis study seeks to answer if early detection of deterioration in cardiac function, venous pressure and microvascular dysfunction can identify patients before the symptoms progress and thus help to initiate early treatment. The hypothesis is that quantitative myocardial stress-perfusion maps improves the pathophysiological insight in patients with UVH.\n\nThe overall goal with this research proposal is to implement combined advanced CMR imaging for a comprehensive non-invasive mapping of functional cardiovascular behavior in patients with complex UVH disease. The outcome of this research may benefit this young adult patient population due to early detection of cardiac disease, less hospitalizations because of heart failure, and eventually decrease morbidity and mortality.",[71,72,73,74],"Univentricular Heart","Microvascular Dysfunction","Heart Failure","Magnetic Resonance",[76,77,78,79,80,81],"Fontan circulation","CMR","stress-perfusion","tissue characterization","univentricle heart","TCPC","2024-12-13",{"date":84,"type":85},"2024-12-16","ACTUAL",{"date":87,"type":85},"2024-04-15",{"date":89,"type":66},"2025-09-01",{"name":5,"class":6},1]