Novel Characterization of Sex Specific Biologic Signatures in Valvular Heart Disease

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test, Other
Study Type: Observational
SUMMARY

This project aims to validate sex-specific biologic signatures associated with aortic valve disease developed in a large multicenter CMR registry, using unsupervised phenomapping. We aim to use advanced CMR techniques (MRF, DTI, chemical exchange transfer, and radiomics analysis) to determine advanced CMR predictors of reverse remodeling following aortic valve surgery and develop sex-specific thresholds for risk. Infrastructure developed by this study will enable development of an innovative, scalable, sex-specific precision medicine cardiovascular imaging pipeline to determine overall risk and treatment response.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

• Age 18-90 years of age

• Suspected moderate or severe (2-3+ or more) aortic regurgitation, or moderate or more aortic stenosis on the basis of prior known clinical history, echocardiogram or cardiac MRI.

Locations
United States
Ohio
Cleveland Clinic
RECRUITING
Cleveland
Contact Information
Primary
Deborah Kwon, MD
kwond@ccf.org
216-444-8526
Time Frame
Start Date: 2024-12-10
Estimated Completion Date: 2030-12-31
Participants
Target number of participants: 200
Treatments
Intervention
Cardiac MRI (CMR) with Magnetic Resonance Fingerprinting (MRF), fSENC (a new CMR technology which may detect subclinical signs of myocardial damage by measuring myocardial strain), Diffusion Tensor imaging (DTI), and chemical exchange transfer imaging with contrast at baseline and without contrast at follow up.~Rapid Assessment of Physical Activity questionnaire Kansas City Cardiomyopathy Questionnaire
Sponsors
Leads: The Cleveland Clinic

This content was sourced from clinicaltrials.gov