Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Genetic Basis for Atrial Fibrillation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03491202
Recruitment Status : Unknown
Verified June 2018 by Katherine Durham MS, APN, Jesse Brown VA Medical Center.
Recruitment status was:  Recruiting
First Posted : April 9, 2018
Last Update Posted : June 11, 2018
Sponsor:
Information provided by (Responsible Party):
Katherine Durham MS, APN, Jesse Brown VA Medical Center

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease
Atrial Fibrillation

Detailed 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.

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 600 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: The Genetic Basis for Atrial Fibrillation
Actual Study Start Date : May 25, 2017
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
atrial fibrillation
Patients with a diagnosis of atrial fibrillation will be eligible for enrollment


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Symptoms related to atrial fibrillation (chest pain, dyspnea, palpitations) [ Time Frame: 1 year ]
  2. heart rate [ Time Frame: 1 year ]

Biospecimen Retention:   Samples With DNA
Blood samples

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Patients will be identified in the outpatient clinic or in the inpatient setting at the Jesse Brown VA Medical Center and approached for informed consent and HIPAA authorization.
Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03491202


Contacts
Layout table for location contacts
Contact: Katherine A Durham, APN 3125696635 Katherine.durham@va.gov

Locations
Layout table for location information
United States, Illinois
Jesse Brown VA Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Katherine A Durham, MS, APN    312-569-6635    Katherine.durham@va.gov   
Principal Investigator: Katherine A Durham, MS, APN         
Principal Investigator: Dawood Darbar, MD         
Sponsors and Collaborators
Jesse Brown VA Medical Center
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Katherine Durham MS, APN, Cardiology Nurse Practitioner, Jesse Brown VA Medical Center
ClinicalTrials.gov Identifier: NCT03491202    
Other Study ID Numbers: 977544
First Posted: April 9, 2018    Key Record Dates
Last Update Posted: June 11, 2018
Last Verified: June 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes