Novel Characterization of Sex Specific Biologic Signatures in Valvular Heart Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorThe Cleveland Clinic
About this trial
This project aims to validate sex-specific biologic signatures associated with aortic valve disease developed in a large multicenter CMR registry, using unsupervised phenomapping.
The aim to use standard and advanced CMR techniques (MRF, DTI, chemical exchange transfer, and radiomics analysis) is 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 criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- CMR
- Quality of Life Questionnaire
Treatment groups
200 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov