Comparative Imaging Assessment of Valvular Heart Disease

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
The Cleveland Clinic
Study ID
NCT04126018
Status
Recruiting
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Conditions

  • Aortic Regurgitation
  • Aortic Stenosis
  • Valve Heart Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • MRI with strain measurement — DIAGNOSTIC_TEST
    CMR measurements of left and right ventricular systolic function strain and myocardial fibrosis
  • Echocardiography — DIAGNOSTIC_TEST
    Doppler, PISA, VCA, volumetric method as performed during echocardiography

Study Details

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.

Key Dates

Start date
Aug 23, 2019
Status verified
Jan 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.
  • Arm: Aortic Stenosis
    Patients with moderate or severe (3+ or 4+) aortic stenosis on the basis of prior known clinical history or clinical exam.
  • Arm: Patients referred for CRT Implantation
    Patients who meet clinical guideline criteria for CRT implantation with EF \< 40%

Primary Outcome Measure

Change in MRI Quantified LVEDVi [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland ClinicClevelandOhio44195
Deborah Kwon, M. D.
[email protected]
216-444-8526
Richard Grimm, MD (SUB_INVESTIGATOR)
Mina Chung, MD (SUB_INVESTIGATOR)
Wlson Tang, MD (SUB_INVESTIGATOR)
Tom Wang, MD (SUB_INVESTIGATOR)
Christopher Nguyen, Ph.D (SUB_INVESTIGATOR)
Tiffany Dong, MD (SUB_INVESTIGATOR)

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