Comparing imaging methods for heart valve disease assessment
Assessment of Left Ventricular Volumes and Strain and Assessment of Valvular Lesions Using Two- and Three-dimensional Echocardiography and Cardiac MRI, a Correlation Study
This study is testing whether a new 3D heart imaging method is better than the traditional 2D method for checking how serious heart valve problems are in people with conditions like aortic stenosis and mitral valve regurgitation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT04126018 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the accuracy of 3D transthoracic echocardiography (TTE) with 2D TTE in evaluating the severity of valvular heart disease, specifically aortic stenosis, aortic regurgitation, and mitral valve regurgitation. It will use cardiac magnetic resonance (CMR) as the reference standard to assess left and right ventricular function and myocardial fibrosis. Participants will complete questionnaires and undergo follow-up assessments, including non-contrast cardiac MRI, to evaluate outcomes such as hospitalization and valve interventions. The study also seeks to determine if myocardial fibrosis severity can predict symptoms and treatment responses.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-90 with suspected moderate to severe mitral or aortic valve disease.
Not a fit: Patients with acute cardiac injuries, congenital heart diseases, or significant claustrophobia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of diagnosing and managing valvular heart disease, leading to better patient outcomes.
How similar studies have performed: Previous studies have shown promising results in using advanced imaging techniques for assessing heart conditions, suggesting this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18-90 years of age * 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: * Acute traumatic cardiac injury * 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
Where this trial is running
Cleveland, Ohio
- Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Deborah Kwon, M. D. — The Cleveland Clinic
- Study coordinator: Deborah Kwon, M. D.
- Email: kwond@ccf.org
- Phone: 216-444-8526
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.