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Novel Characterization of Sex Specific Biologic Signatures in Valvular Heart Disease

RECRUITINGSponsored by The Cleveland Clinic
Actively Recruiting
SponsorThe Cleveland Clinic
Started2024-12-10
Est. completion2030-12-31
Eligibility
Age18 Years – 90 Years
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →

NCT06780241

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. 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

Age: 18 Years – 90 YearsHealthy volunteers accepted
Inclusion Criteria:

* 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.

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 cardiac MRI including:

  * Patients with any MR-incompatible implant, including cardiac pacemakers or defibrillators, or older types of cerebral aneurysm clips.
  * Patients who weigh more than 440 lbs. or have a very wide waist circumference.
  * Patients with claustrophobia may have difficulty tolerating the exam.

Conditions4

Aortic RegurgitationAortic StenosisHeart DiseaseMitral Regurgitation

Locations1 site

Cleveland Clinic
Cleveland, Ohio, 44195
Degorah Kwon, MD216-444-8526

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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