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

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ClinicalTrials.gov Identifier: NCT01970969
Recruitment Status : Completed
First Posted : October 28, 2013
Last Update Posted : April 17, 2018
Sponsor:
Collaborator:
Quest Diagnostics
Information provided by (Responsible Party):
Scripps Translational Science Institute

Brief Summary:
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 or disease
Patients With Symptoms of Cardiac Arrhythmia at Risk for Atrial Fibrillation

Study Type : Observational
Actual Enrollment : 928 participants
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.
Study Start Date : September 2013
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Group/Cohort
Cardiac arrhythmia symptoms
All subjects enrolled in the study will have an iRhythm Zio patch placed and a blood sample obtained.



Primary Outcome Measures :
  1. Association between events of Atrial Fibrillation and 4-SNP risk score [ Time Frame: One time ]
    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.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Scripps Translational Science Institute
ClinicalTrials.gov Identifier: NCT01970969     History of Changes
Other Study ID Numbers: 13-6159
First Posted: October 28, 2013    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018

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