Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2026-03-03 @ 12:38 AM
Study NCT ID:
NCT04126018
Status:
RECRUITING
Last Update Posted:
2024-12-24
First Post:
2019-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Imaging Assessment of Valvular Heart Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D001024', 'term': 'Aortic Valve Stenosis'}, {'id': 'D001022', 'term': 'Aortic Valve Insufficiency'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}, {'id': 'D004452', 'term': 'Echocardiography'}], 'ancestors': [{'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D057791', 'term': 'Cardiac Imaging Techniques'}, {'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'As part of an optional sub study, subjects will be asked to provide blood samples at the baseline visit. Up to 5 tablespoons (75ml) of blood will be drawn. Genomic analyses will be run on the samples to look for biomarkers which may correlate with the development of myocardial fibrosis.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-08-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-19', 'studyFirstSubmitDate': '2019-08-20', 'studyFirstSubmitQcDate': '2019-10-11', 'lastUpdatePostDateStruct': {'date': '2024-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in MRI Quantified LVEDVi', 'timeFrame': '6 months', 'description': '10% Change from Baseline - units of measure cc/m2'}, {'measure': 'Change in MRI Quantified LVESVi', 'timeFrame': '6 months', 'description': '15% Change from Baseline - units of measure cc/m2'}, {'measure': 'Change in MRI Quantified LV Strain', 'timeFrame': '6 months', 'description': '5% Change from Baseline'}, {'measure': 'Change in MRI LVEF', 'timeFrame': '6 Months', 'description': '5% Change from Baseline'}, {'measure': 'Change in Kansas City Cardiomyopathy Questionnaire Answers', 'timeFrame': '6 Months', 'description': 'Change in quality of life related to heart failure symptoms.'}, {'measure': 'Change in Physical Activity Questionnaire Answers', 'timeFrame': '6 Months', 'description': 'Change in physical activity level due to heart failure symptoms.'}, {'measure': 'All-cause mortality', 'timeFrame': '6 Months', 'description': 'number of patients expired'}, {'measure': 'Development of class I or IIa indication for valve surgery', 'timeFrame': '6 Months', 'description': 'The recommended indications for surgery include: development of symptoms, LV dysfunction (LV end-systolic diameter ≥45 mm or LV ejection fraction ≤60%), and new onset of atrial fibrillation or pulmonary hypertension (systolic pulmonary artery pressure \\>50 mm Hg at rest).'}], 'secondaryOutcomes': [{'measure': 'Accuracy of echocardiography as compared with MRI', 'timeFrame': '6 Months', 'description': 'Comparison of MRI measurements based on standard of care echocardiography.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Valve Heart Disease', 'Aortic Stenosis', 'Aortic Regurgitation']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to compare the various 2D and 3D methods of valvular heart disease quantification (Doppler, PISA, VCA, volumetric method) and strain with cardiac magnetic resonance (CMR) measurements of left and right ventricular systolic function strain and myocardial fibrosis assessment.', 'detailedDescription': 'The objective of this study is to compare the accuracy of 3D TTE to 2D TTE in assessing the severity of valvular heart disease in patients with aortic stenosis, aortic regurgitation, and mitral valve regurgitation by comparing this to the reference standard of cardiac magnetic resonance (CMR) in subjects with different etiologies and mechanisms of valvular lesions and to the integrative method of valvular lesion grading as recommended by inter-societal guidelines. Another objective is to assess prevalence of focal and diffuse myocardial fibrosis as assessed by CMR in patients with aortic stenosis, aortic regurgitation and mitral regurgitation. In addition, the investigators aim to determine whether severity of myocardial fibrosis predicts onset of symptoms, referral for valve surgery and adverse ventricular remodeling. The investigators also aim to look at patients who will be undergoing CRT implant to predict their response to therapy.\n\nAt baseline, the Rapid Assessment of Physical Activity questionnaire and the Kansas City Cardiomyopathy Questionnaire will be completed. A 6-12 month follow-up is required and will include an abbreviated non-contrast research cardiac MRI and subject questionnaires.\n\nOther follow-up will include using electronic medical records and the Social Security Death Index database for outcomes such as death, hospitalization for heart failure, mitral or aortic valve interventions and cardiovascular death.\n\nSelect patients will be asked to undergo a supine bicycle exercise stress MRI at enrollment. Approximately 40 subjects will be included in this substudy.\n\nAdditional exclusion criteria for this substudy:\n\n* Unable to pedal a supine bicycle\n* Require supplemental oxygen\n\nDuring the exercise stress MRI, patients will be asked to cycle on a supine bike that will be mounted on the MRI platform. During this test, a caregiver will be present. An electrocardiogram (ECG) will be used to obtain tracings of cardiac activity. Respirations, blood pressure, and heart rate are also monitored during exercise. The test is continued until peak exercise level or target heart rate is achieved. As soon as the exercise portion is complete, MRI images will be acquired. When the test is complete, patients will be monitored until ECG, heart rate, and breathing have returned to baseline. Patients will be assessed for symptoms such as chest pain, dyspnea, leg pain, dizziness, or fatigue and may be given medications or instructed to stop the test early as necessary.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with suspected chronic AS, AR, MR or heart failure with reduced ejection fraction being evaluated for CRT implantation referred for clinically indicated CMR and echocardiography by their cardiologists.. CMR and echocardiography will be clinically indicated in this study group.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-90 years of age\n* Suspected moderate or severe MR,AR or AS on the basis of prior known clinical history or clinical exam.\n* Suspected CRT "non-responder" with an implanted MRI compatible CRT device and reduced ejection fraction\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 CMR\n* Moderate or severe dysfunction in multiple valves\n* Patients with significant claustrophobia'}, 'identificationModule': {'nctId': 'NCT04126018', 'briefTitle': 'Comparative Imaging Assessment of Valvular Heart Disease', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'officialTitle': 'Assessment of Left Ventricular Volumes and Strain and Assessment of Valvular Lesions Using Two- and Three-dimensional Echocardiography and Cardiac MRI, a Correlation Study', 'orgStudyIdInfo': {'id': '19-549'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Mitral Valve Regurgitation', 'description': 'Patients with moderate or severe (3+ or 4+) mitral valve regurgitation on the basis of prior known clinical history or clinical exam.', 'interventionNames': ['Diagnostic Test: MRI with strain measurement', 'Diagnostic Test: Echocardiography']}, {'label': 'Aortic Valve Regurgitation', 'description': 'Patients with moderate or severe (3+ or 4+) aortic valve regurgitation on the basis of prior known clinical history or clinical exam.', 'interventionNames': ['Diagnostic Test: MRI with strain measurement', 'Diagnostic Test: Echocardiography']}, {'label': 'Aortic Stenosis', 'description': 'Patients with moderate or severe (3+ or 4+) aortic stenosis on the basis of prior known clinical history or clinical exam.', 'interventionNames': ['Diagnostic Test: MRI with strain measurement', 'Diagnostic Test: Echocardiography']}, {'label': 'Patients referred for CRT Implantation', 'description': 'Patients who meet clinical guideline criteria for CRT implantation with EF \\< 40%', 'interventionNames': ['Diagnostic Test: MRI with strain measurement', 'Diagnostic Test: Echocardiography']}], 'interventions': [{'name': 'MRI with strain measurement', 'type': 'DIAGNOSTIC_TEST', 'description': 'CMR measurements of left and right ventricular systolic function strain and myocardial fibrosis', 'armGroupLabels': ['Aortic Stenosis', 'Aortic Valve Regurgitation', 'Mitral Valve Regurgitation', 'Patients referred for CRT Implantation']}, {'name': 'Echocardiography', 'type': 'DIAGNOSTIC_TEST', 'description': 'Doppler, PISA, VCA, volumetric method as performed during echocardiography', 'armGroupLabels': ['Aortic Stenosis', 'Aortic Valve Regurgitation', 'Mitral Valve Regurgitation', 'Patients referred for CRT Implantation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Deborah Kwon, M. D.', 'role': 'CONTACT', 'email': 'kwond@ccf.org', 'phone': '216-444-8526'}, {'name': 'Richard Grimm, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Mina Chung, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Wlson Tang, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Tom Wang, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Christopher Nguyen, Ph.D', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Tiffany Dong, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'centralContacts': [{'name': 'Deborah Kwon, M. D.', 'role': 'CONTACT', 'email': 'kwond@ccf.org', 'phone': '216-444-8526'}], 'overallOfficials': [{'name': 'Deborah Kwon, M. D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Deborah Kwon, MD', 'investigatorAffiliation': 'The Cleveland Clinic'}}}}