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
|Condition or disease|
|Patients With Symptoms of Cardiac Arrhythmia at Risk for Atrial Fibrillation|
|Study Type :||Observational|
|Actual Enrollment :||928 participants|
|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|
Cardiac arrhythmia symptoms
All subjects enrolled in the study will have an iRhythm Zio patch placed and a blood sample obtained.
- 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
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
|United States, California|
|La Jolla, California, United States, 92037|
|Principal Investigator:||Eric Topol, MD||Scripps Translational Science Institute|