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

Scripps Translational Science Institute

Status: Completed

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

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01970969

13-6159

Details and patient eligibility

About

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.

Enrollment: 928 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

928 participants in 1 patient group

Cardiac arrhythmia symptoms

Description:

All subjects enrolled in the study will have an iRhythm Zio patch placed and a blood sample obtained.