Novel Characterization of Sex Specific Biologic Signatures in Valvular Heart Disease

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
The Cleveland Clinic
Study ID
NCT06780241
Status
Recruiting
Apply to this trial

Conditions

  • Aortic Regurgitation
  • Aortic Stenosis
  • Mitral Regurgitation

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • CMR — DIAGNOSTIC_TEST
    CMR (with contrast at baseline and non-contrast at follow-up)
  • Quality of Life Questionnaire — OTHER
    Rapid Assessment of Physical Activity questionnaire and the Kansas City Cardiomyopathy Questionnaire

Study Details

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.

Key Dates

Start date
Dec 10, 2024
Status verified
Dec 2025
Primary completion
Dec 31, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: 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

Primary Outcome Measure

Change in LV Dilation and/or change in LVEF [ Time Frame: 6-12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland ClinicClevelandOhio44195
Degorah Kwon, MD
216-444-8526
Lydia DeAngelo
[email protected]
401-225-1929
Xiaofeng Wang, PhD (SUB_INVESTIGATOR)
Christopher Nguyen, PhD (SUB_INVESTIGATOR)
Eric Roselli, MD (SUB_INVESTIGATOR)

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