RECRUITING

Novel Characterization of Sex Specific Biologic Signatures in Valvular Heart Disease

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Conditions

Aortic RegurgitationMitral RegurgitationAortic Stenosis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Novel Characterization of Sex Specific Biologic Signatures in Valvular Heart Disease

Quick Facts

Study Start:2024-12-10
Study Completion:2030-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06780241

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18-90 years of age
  2. * 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.
  1. * Acute traumatic cardiac injury
  2. * Aortic dissection or aortic root rupture
  3. * Congenital heart diseases such as patent ductus arteriosus, coarctation of aorta, ASD and VSD
  4. * Presence of A-V fistula or intracardiac shunts
  5. * Any contraindications to cardiac MRI including:
  6. * Patients with any MR-incompatible implant, including cardiac pacemakers or defibrillators, or older types of cerebral aneurysm clips.
  7. * Patients who weigh more than 440 lbs. or have a very wide waist circumference.
  8. * Patients with claustrophobia may have difficulty tolerating the exam.

Contacts and Locations

Study Contact

Deborah Kwon, MD
CONTACT
216-444-8526
kwond@ccf.org

Principal Investigator

Deborah Kwon, MD
PRINCIPAL_INVESTIGATOR
The Cleveland Clinic

Study Locations (Sites)

Cleveland Clinic
Cleveland, Ohio, 44195
United States

Collaborators and Investigators

Sponsor: The Cleveland Clinic

  • Deborah Kwon, MD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-10
Study Completion Date2030-12-31

Study Record Updates

Study Start Date2024-12-10
Study Completion Date2030-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Aortic Regurgitation
  • Mitral Regurgitation
  • Aortic Stenosis