The Genetic Basis for Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

The Genetic Basis for Atrial Fibrillation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03491202
• Other study ID #: 977544
• Status: Recruiting
• Start date: May 25, 2017
• Est. completion date: May 2022

Study information

• Verified date: June 2018
• Source: Jesse Brown VA Medical Center
• Contact: Katherine A Durham, APN
• Phone: 3125696635
• Email: Katherine.durham[@]va.gov
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Atrial fibrillation (AF) is reaching epidemic proportions in the aging U.S. and European populations, but the mechanisms of increased susceptibility to atrial fibrillation are still unknown. In this study, we look to further examine genetic and medical co-morbidity influence of atrial fibrillation duration and response to medications. In Specific Aim 1, we propose the creation of a Veterans Affairs AF Biorepository (VAAFBio), which is a resource that will collect and store clinical, demographic, blood and DNA samples from patients with atrial fibrillation to aide this study and future studies of this type in the VA population. In Specific Aim 2, examine common genetic polymorphisms in veteran patients with atrial fibrillation and examine gene-environment interactions with risk factors for atrial fibrillation.

Description:

Atrial fibrillation (AF) is reaching epidemic proportions in the aging U.S. and European populations, but the mechanisms of increased susceptibility to atrial fibrillation are still unknown. In this study, the investigators look to further examine genetic and medical co-morbidity influence of atrial fibrillation duration and response to medications. In Specific Aim 1, the investigators propose the creation of a Veterans Affairs AF Biorepository (VAAFBio), which is a resource that will collect and store clinical, demographic, blood and DNA samples from patients with atrial fibrillation to aide this study and future studies of this type in the VA population. In Specific Aim 2, the investigators will examine common genetic polymorphisms in veteran patients with atrial fibrillation and examine gene-environment interactions with risk factors for atrial fibrillation.

Patients will be identified through the VA inpatient and outpatient clinic, and will be approached for inclusion in the study. The target enrollment for the research and biorepository is 600 participants. A detailed family history, medical background, study questionnaires and a blood sample will then be obtained by the principal investigator or a research coordinator, following written informed consent under a protocol approved by the Jesse Brown VA Institutional Review Board. Once enough samples are collected, coded DNA samples will be sent out to analyze for linkage to known/candidate loci for AF.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: May 2022
• Est. primary completion date: May 2022
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Subjects must be at least 18 years of age, and up to 100.

• Subjects must have a documented history of atrial fibrillation by ECG, ECHO, and or Holter monitor event recorder.

• Subjects must be willing to give written, informed consent.

Exclusion Criteria:

• Patients with a history of AF or atrial flutter that is only associated with cardiac surgery will be excluded from the study.

• Subjects who cannot speak English will be excluded from the study.

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
United States	Jesse Brown VA Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Jesse Brown VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptoms related to atrial fibrillation (chest pain, dyspnea, palpitations)		1 year
Primary	heart rate		1 year