[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100576050":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":25,"centralContacts":29,"locations":34,"responsibleParty":63,"collaborators":10,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":69,"acronym":10,"eligibilityCriteria":70,"healthyVolunteers":67,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":10,"studyType":77,"phases":10,"briefSummary":78,"conditions":79,"keywords":10,"overallStatus":37,"whyStopped":10,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"The Cleveland Clinic","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention",null,"Cardiac MRI (CMR) with Magnetic Resonance Fingerprinting (MRF), fSENC (a new CMR technology which may detect subclinical signs of myocardial damage by measuring myocardial strain), Diffusion Tensor imaging (DTI), and chemical exchange transfer imaging with contrast at baseline and without contrast at follow up.\n\nRapid Assessment of Physical Activity questionnaire Kansas City Cardiomyopathy Questionnaire",[13,14],"Diagnostic Test: CMR","Other: Quality of Life Questionnaire",[16,21],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":10},"DIAGNOSTIC_TEST","CMR","CMR (with contrast at baseline and non-contrast at follow-up)",[9],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"Quality of Life Questionnaire","Rapid Assessment of Physical Activity questionnaire and the Kansas City Cardiomyopathy Questionnaire",[9],[26],{"name":27,"affiliation":5,"role":28},"Deborah Kwon, MD","PRINCIPAL_INVESTIGATOR",[30],{"name":27,"role":31,"phone":32,"phoneExt":10,"email":33},"CONTACT","216-444-8526","kwond@ccf.org",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Cleveland Clinic","RECRUITING","Cleveland","Ohio","44195","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-81.69541,41.4995,{"lat":47,"lon":46},[50,52,56,59,61],{"name":51,"role":31,"phone":32,"phoneExt":10,"email":10},"Degorah Kwon, MD",{"name":53,"role":31,"phone":54,"phoneExt":10,"email":55},"Lydia DeAngelo","401-225-1929","deangel2@ccf.org",{"name":57,"role":58,"phone":10,"phoneExt":10,"email":10},"Xiaofeng Wang, PhD","SUB_INVESTIGATOR",{"name":60,"role":58,"phone":10,"phoneExt":10,"email":10},"Christopher Nguyen, PhD",{"name":62,"role":58,"phone":10,"phoneExt":10,"email":10},"Eric Roselli, MD",{"type":28,"investigatorFullName":27,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Principal Investigator","100576050","novel-characterization-of-sex-specific-biologic-signatures-in-valvular-heart-disease-100576050",false,"NCT06780241","Novel Characterization of Sex Specific Biologic Signatures in Valvular Heart Disease","Inclusion Criteria:\n\n* Age 18-90 years of age\n* Suspected moderate or severe (2-3+ or more) aortic regurgitation, or moderate or more aortic stenosis on the basis of prior known clinical history, echocardiogram or cardiac MRI.\n\nExclusion Criteria:\n\n* Acute traumatic cardiac injury\n* Aortic dissection or aortic root rupture\n* Congenital heart diseases such as patent ductus arteriosus, coarctation of aorta, ASD and VSD\n* Presence of A-V fistula or intracardiac shunts\n* Any contraindications to cardiac MRI including:\n\n  * Patients with any MR-incompatible implant, including cardiac pacemakers or defibrillators, or older types of cerebral aneurysm clips.\n  * Patients who weigh more than 440 lbs. or have a very wide waist circumference.\n  * Patients with claustrophobia may have difficulty tolerating the exam.","ALL","18 Years","90 Years",{"count":75,"type":76},200,"ESTIMATED","OBSERVATIONAL","This project aims to validate sex-specific biologic signatures associated with aortic valve disease developed in a large multicenter CMR registry, using unsupervised phenomapping.\n\nThe aim to use standard and advanced CMR techniques (MRF, DTI, chemical exchange transfer, and radiomics analysis) is to determine advanced CMR predictors of reverse remodeling following aortic valve surgery and develop sex-specific thresholds for risk. Infrastructure developed by this study will enable development of an innovative, scalable, sex-specific precision medicine cardiovascular imaging pipeline to determine overall risk and treatment response.",[80,81,82],"Aortic Regurgitation","Mitral Regurgitation","Aortic Stenosis","2025-12-28",{"date":85,"type":86},"2026-01-02","ACTUAL",{"date":88,"type":86},"2024-12-10",{"date":90,"type":76},"2030-12-31",{"name":5,"class":6},1]