Comparative Imaging Assessment of Valvular Heart Disease
NCT ID: NCT04126018
Last Updated: 2024-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2019-08-23
2026-06-30
Brief Summary
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Detailed Description
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At 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.
Other 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.
Select patients will be asked to undergo a supine bicycle exercise stress MRI at enrollment. Approximately 40 subjects will be included in this substudy.
Additional exclusion criteria for this substudy:
* Unable to pedal a supine bicycle
* Require supplemental oxygen
During 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Mitral Valve Regurgitation
Patients with moderate or severe (3+ or 4+) mitral valve regurgitation on the basis of prior known clinical history or clinical exam.
MRI with strain measurement
CMR measurements of left and right ventricular systolic function strain and myocardial fibrosis
Echocardiography
Doppler, PISA, VCA, volumetric method as performed during echocardiography
Aortic Valve Regurgitation
Patients with moderate or severe (3+ or 4+) aortic valve regurgitation on the basis of prior known clinical history or clinical exam.
MRI with strain measurement
CMR measurements of left and right ventricular systolic function strain and myocardial fibrosis
Echocardiography
Doppler, PISA, VCA, volumetric method as performed during echocardiography
Aortic Stenosis
Patients with moderate or severe (3+ or 4+) aortic stenosis on the basis of prior known clinical history or clinical exam.
MRI with strain measurement
CMR measurements of left and right ventricular systolic function strain and myocardial fibrosis
Echocardiography
Doppler, PISA, VCA, volumetric method as performed during echocardiography
Patients referred for CRT Implantation
Patients who meet clinical guideline criteria for CRT implantation with EF \< 40%
MRI with strain measurement
CMR measurements of left and right ventricular systolic function strain and myocardial fibrosis
Echocardiography
Doppler, PISA, VCA, volumetric method as performed during echocardiography
Interventions
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MRI with strain measurement
CMR measurements of left and right ventricular systolic function strain and myocardial fibrosis
Echocardiography
Doppler, PISA, VCA, volumetric method as performed during echocardiography
Eligibility Criteria
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Inclusion Criteria
* Suspected moderate or severe MR,AR or AS on the basis of prior known clinical history or clinical exam.
* Suspected CRT "non-responder" with an implanted MRI compatible CRT device and reduced ejection fraction
Exclusion Criteria
* Aortic dissection or aortic root rupture
* Congenital heart diseases such as patent ductus arteriosus, coarctation of aorta, ASD and VSD
* Presence of A-V fistula or intracardiac shunts
* Any contraindications to CMR
* Moderate or severe dysfunction in multiple valves
* Patients with significant claustrophobia
18 Years
90 Years
ALL
No
Sponsors
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The Cleveland Clinic
OTHER
Responsible Party
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Deborah Kwon, MD
Principal Investigator
Principal Investigators
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Deborah Kwon, M. D.
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Locations
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Cleveland Clinic
Cleveland, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Deborah Kwon, M. D.
Role: primary
Other Identifiers
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19-549
Identifier Type: -
Identifier Source: org_study_id