RECRUITING

Prospective Phenotyping for Genetic Subtypes of Early-onset Atrial Fibrillation

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 is a prospective, case-control study that seeks to learn about the role of genetics in early onset atrial fibrillation (AF) and if genetic testing can be used to improve how the investigators treat atrial fibrillation. The study will enroll 225 participants. Eligible participants will have undergone sequencing for arrhythmia and cardiomyopathy (CM) genes. Based on those results, participants will be recruited for an outpatient research visit with testing that includes cardiac MRI, rest/stress/signal-averaged ECGs, and cardiac monitoring. If an inherited arrhythmia/CM syndrome is diagnosed, guideline-directed changes to medical care will be recommended.

Official Title

Prospective Phenotyping for Genetic Subtypes of Early-onset Atrial Fibrillation

Quick Facts

Study Start:2022-04-27
Study Completion:2026-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05190679

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:15 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Not specified
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Minors \>15 years
  2. * Adult \> 18 years
  3. * Able to provide written informed consent
  4. * Previously enrolled in the Vanderbilt Atrial Fibrillation Registry (IVR#020669)
  5. * Atrial Fibrillation Ablation Registry (IRB#110881)
  6. * Early-onset Atrial Fibrillation Registry (IRB#201666)
  7. * Underwent whole genome sequencing/whole exome sequencing or clinical genetic testing and based on those results meets the genetic criteria for cases and controls as defined as a Cardiomyopathy (CM) Rare Variant (P/LP rare variant in CM gene, Arrhythmia Rare Variant (P/LP rare variant in arrhythmia gene), or a Control (no rare variant in CM, arrhythmia, or other Atrial Fibrillation gene).
  8. * Diagnosis of Atrial Fibrillation prior to age of 65 (\</=65)
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Hollie Williams, MSN
CONTACT
615-875-0405
Hollie.Williams@vumc.org

Principal Investigator

M. B Shoemaker, MD
PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center

Study Locations (Sites)

Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States

Collaborators and Investigators

Sponsor: Vanderbilt University Medical Center

  • M. B Shoemaker, MD, PRINCIPAL_INVESTIGATOR, Vanderbilt University Medical Center

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 Date2022-04-27
Study Completion Date2026-10

Study Record Updates

Study Start Date2022-04-27
Study Completion Date2026-10

Terms related to this study

Keywords Provided by Researchers

  • Genetic disease

Additional Relevant MeSH Terms

  • Atrial Fibrillation