THE GIRAFFE Study: Genomic Risk Markers for Atrial Fibrillation Following Extended Cardiac Rhythm Monitoring (GIRAFFE)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Quest Diagnostics
Information provided by (Responsible Party):
Scripps Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01970969
First received: October 8, 2013
Last updated: April 18, 2016
Last verified: April 2016
  Purpose
Our primary hypothesis is that a risk score comprised of approximately 10 single nucleotide polymorphisms (SNPs) that are associated with atrial fibrillation at the Genome Wide Association Study (GWAS) level is associated with the development of atrial fibrillation among previously undiagnosed patients at high risk for atrial fibrillation. A current example of these SNPs is shown in Table 1. As a secondary hypothesis, we will test the association between atrial fibrillation diagnosed in this study with a subset of SNPs reported to be associated with atrial fibrillation and with fine-mapping SNPs. We will also test the association between atrial fibrillation of less than and greater than 30 seconds and a panel of approximately 10 SNPs.

Condition
Patients With Symptoms of Cardiac Arrhythmia at Risk for Atrial Fibrillation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: This Study Will Investigate the Association Between a Set of Single Nucleotide Polymorphisms (SNPs) and Atrial Fibrillation in Patients at High Risk of Developing Atrial Fibrillation. The SNPs Investigated Will Have Been Previously Shown to be Associated With the Atrial Fibrillation.

Resource links provided by NLM:


Further study details as provided by Scripps Translational Science Institute:

Primary Outcome Measures:
  • Association between events of Atrial Fibrillation and 4-SNP risk score [ Time Frame: One time ] [ Designated as safety issue: No ]
    SNP effect sizes and frequencies were determined from the literature and the International HapMap Project database as indicated in Table 1. Expected occurrences of atrial fibrillation in the two groups were calculated using reference to previous studies as outlined above [7, 8, 33]. We expect 80 atrial fibrillation events in a 650 high-risk patients [48, 49]. Using these event rates and an alpha error of 5%, the power to detect an association between a 10-SNPs risk score and atrial fibrillation is >90%. The power to detect association between a 4-SNP risk score and atrial fibrillation is >80%.


Biospecimen Retention:   None Retained
A blood sample (in a 4 ml EDTA tube) for genotyping and a serum sample (in two 10ml red top tubes) will be obtained from each patient.

Enrollment: 928
Study Start Date: September 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cardiac arrhythmia symptoms
All subjects enrolled in the study will have an iRhythm Zio patch placed and a blood sample obtained.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients defined, as high risk for atrial fibrillation will be persons with:

  1. No prior history of atrial fibrillation and/or atrial flutter (AFIB/AF) - with symptoms of high clinical suspicion for AFIB/AF prompting referral for ambulatory cardiac rhythm monitoring to evaluate for potential AFIB/AF, and
  2. Any of the following features: ischemic stroke with no defined etiology (In prior 6 months) [3, 4, 6, 7], hypertension [33], increased body mass index (BMI >30kg/m2) [33], heart failure [33], clinically significant murmur [33], prolonged PR interval on resting ECG (>200msec) [33], chronic kidney disease [34], hypertrophic cardiomyopathy [35], congenital heart disease [36], chronic obstructive pulmonary disease [37, 38], sleep apnea [39-41], thyroid disease [42, 43], family history of atrial fibrillation [44], diabetes [45] or excess alcohol consumption (Male > 14 drinks/week, Female >7 drinks/week)[46].
Criteria

Inclusion Criteria:

  • Symptoms of high clinical suspicion for atrial fibrillation prompting referral for ambulatory cardiac rhythm monitoring for potential atrial fibrillation.

AND

  • At high risk for atrial fibrillation, defined as any one of the following: ischemic stroke with no defined etiology (In prior 6 months) [3, 4, 6, 7], hypertension [33], increased body mass index (BMI >30kg/m2) [33], heart failure [33], clinically significant murmur [33], prolonged PR interval on resting ECG [33], chronic kidney disease [34], hypertrophic cardiomyopathy [35], congenital heart disease [36], chronic obstructive pulmonary disease [37, 38], sleep apnea [39-41], thyroid disease [42, 43], family history of atrial fibrillation [44], diabetes [45] or excess alcohol consumption (Male > 14 drinks/week, Female >7 drinks/week)[46].
  • Age 40 years or older
  • Capable of providing informed consent
  • Capable of wearing a Zio Patch for up to 14 days
  • Capable of providing a blood sample

Exclusion Criteria:

  • Previously documented atrial fibrillation or atrial flutter.
  • Prior cardiac surgery (coronary artery bypass grafting, valve replacement or repair, pericardial stripping, etc) within the past 30 days.
  • Hyperthyroidism.
  • Have known skin allergies, conditions, or sensitivities (e.g. allergy to adhesives, psoriasis) as the Zio Patch should not be used on patients with known skin allergies, conditions, or sensitivities.
  • Are receiving pacing therapy.
  • Are anticipated to receive or require external cardiac defibrillation during the monitoring period.
  • Are anticipated to have exposure to high frequency surgical equipment during the monitoring period.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01970969

Locations
United States, California
Scripps Clinic
La Jolla, California, United States, 92037
Sponsors and Collaborators
Scripps Translational Science Institute
Quest Diagnostics
Investigators
Principal Investigator: Eric Topol, MD Scripps Translational Science Institute
  More Information

Responsible Party: Scripps Translational Science Institute
ClinicalTrials.gov Identifier: NCT01970969     History of Changes
Other Study ID Numbers: 13-6159 
Study First Received: October 8, 2013
Last Updated: April 18, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Scripps Translational Science Institute:
Atrial Fibrillation
Cardiac monitoring
Genomics

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 27, 2016