Actively Recruiting
Assessment of Left Ventricular Volumes and Strain and Valvular Lesions Using 2D and 3D Echocardiography Compared to Cardiac MRI
Led by The Cleveland Clinic · Updated on 2026-01-13
200
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating different 2D and 3D echocardiography methods to measure the severity of valvular heart disease, including Doppler, PISA, VCA, and volumetric techniques. The study focuses on patients with aortic stenosis, aortic regurgitation, and mitral valve regurgitation. It aims to compare these methods with cardiac magnetic resonance (CMR), considered the reference standard, to assess left and right ventricular function, strain, and myocardial fibrosis. The study also explores whether the extent of myocardial fibrosis predicts symptom development, valve surgery referrals, and heart remodeling, and will examine patients undergoing cardiac resynchronization therapy (CRT) implantation to predict therapy response. Participants will undergo 2D and 3D transthoracic echocardiography (TTE) and CMR, including strain measurements and myocardial fibrosis assessment. Some patients will participate in a substudy involving exercise stress MRI with a supine bicycle. At enrollment, questionnaires assessing physical activity and heart failure symptoms will be completed, with follow-up at 6 to 12 months including a non-contrast cardiac MRI and repeat questionnaires. Outcomes will be tracked through medical records and death registries. Monitoring during the exercise MRI includes ECG, blood pressure, heart rate, and symptom assessments, with safety measures in place. Throughout the study, participants will complete questionnaires, undergo various cardiac imaging tests, and have their clinical outcomes followed for events such as hospitalizations, valve interventions, and mortality. The main outcomes measured at 6 months include changes in left ventricular volumes and function by MRI, symptom scores, physical activity levels, mortality, and indications for valve surgery. The study seeks to provide detailed comparisons of imaging methods and understand how myocardial fibrosis relates to clinical outcomes in valvular heart disease.
CONDITIONS
Brief Title
Comparative Imaging Assessment of Valvular Heart Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 90 years
- Suspected moderate or severe mitral regurgitation, aortic regurgitation, or aortic stenosis based on clinical history or exam
- Suspected CRT non-responder with an implanted MRI-compatible CRT device and reduced ejection fraction
You will not qualify if you...
- Acute traumatic cardiac injury
- Aortic dissection or aortic root rupture
- Congenital heart diseases such as patent ductus arteriosus, coarctation of aorta, atrial septal defect, and ventricular septal defect
- Presence of arteriovenous fistula or intracardiac shunts
- Any contraindications to cardiac magnetic resonance imaging
- Moderate or severe dysfunction in multiple valves
- Significant claustrophobia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Baseline assessment
Participants undergo cardiac imaging including 2D and 3D echocardiography and cardiac magnetic resonance imaging (MRI) to assess valvular heart disease and myocardial fibrosis.
1 visit (in-person)
Duration - 6 to 12 months
Participants complete questionnaires and undergo follow-up cardiac MRI approximately 6 to 12 months after baseline. Additional monitoring for clinical outcomes such as hospitalization and valve interventions is performed through medical records and databases.
1 follow-up visit and ongoing medical record monitoring
Trial Site Locations
Total: 1 location
1
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
D
Deborah Kwon, M. D.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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