NCT03491202

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 25, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 9, 2018

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

June 11, 2018

Status Verified

June 1, 2018

Enrollment Period

4.9 years

First QC Date

April 2, 2018

Last Update Submit

June 8, 2018

Conditions

Outcome Measures

Primary Outcomes (2)

  • Symptoms related to atrial fibrillation (chest pain, dyspnea, palpitations)

    1 year

  • heart rate

    1 year

Study Arms (1)

atrial fibrillation

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

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jesse Brown VA Medical Center

Chicago, Illinois, 60612, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Katherine A Durham, APN

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cardiology Nurse Practitioner

Study Record Dates

First Submitted

April 2, 2018

First Posted

April 9, 2018

Study Start

May 25, 2017

Primary Completion

May 1, 2022

Study Completion

May 1, 2022

Last Updated

June 11, 2018

Record last verified: 2018-06

Locations