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

Completed

Conditions studied: Patients With Symptoms of Cardiac Arrhythmia at Risk for Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT01970969

Run by

Scripps Translational Science Institute

People needed

928

Starts

2013-09-01

Expected to finish

2017-12-01

Last updated by the study team

2018-04-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Scripps Clinic — La Jolla, California, United States

Full record on ClinicalTrials.gov

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