Atrial FibrillationNCT03491202
The Genetic Basis for Atrial Fibrillation
An observational study of Atrial Fibrillation, run by Jesse Brown VA Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 25 May 2017to May 2022
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Jesse Brown VA Medical Center
Chicago, Illinois, 60612
Katherine A Durham, MS, APN, 312-569-6635, Katherine.durham@va.gov
Katherine A Durham, MS, APN
About this study
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.
Read the 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.
- Conditions
- Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| atrial fibrillation | Patients with a diagnosis of atrial fibrillation will be eligible for enrollment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms related to atrial fibrillation (chest pain, dyspnea, palpitations)
Measured: 1 year
heart rate
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2018
- Study start25 May 2017
- Primary completionMay 2022 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Jesse Brown VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Katherine Durham MS, APN, Jesse Brown VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03491202
- Sponsor's protocol ID
- 977544
- Status last verified
- Jun 2018
- First submitted
- 2 Apr 2018
- Last updated
- 11 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Genetic Basis for Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT03491202
- Acronym / sponsor ID
- 977544
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Jesse Brown VA Medical CenterUS federal agency
- Study start
- 25 May 2017 (actual)
- Primary completion
- May 2022 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 9 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| atrial fibrillation | – | –Patients with a diagnosis of atrial fibrillation will be eligible for enrollment |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Symptoms related to atrial fibrillation (chest pain, dyspnea, palpitations)
Time frame: 1 year
heart rate
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2018.
Related trials for Atrial Fibrillation
Active, not recruiting
VOLT CE Mark Study
Atrial Arrhythmia, Atrial Fibrillation
RecruitingObservational study
AI-Based Cardiac Analysis Using 12-Lead and 1-Lead ECG
Heart Failure, Atrial Fibrillation (AF)
RecruitingObservational study
Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax
Chronic Lymphocytic Leukemia (CLL), Waldenstr(SqrRoot)(Delta)m s Macroglobulinemia
Not yet recruiting
CATCH AF - Atrial Fibrillation Detection in Cryptogenic Stroke
Atrial Fibrillation (AF)
Active, not recruiting
ARIADNE Clinical Trial
Persistent Atrial Fibrillation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Jesse Brown VA Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katherine A Durham, APN (3125696635, Katherine.durham@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptoms related to atrial fibrillation (chest pain, dyspnea, palpitations) (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2018.