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NCT01970969 · ClinicalTrials.gov registry record

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

A clinical trial, sponsored by Scripps Translational Science Institute.

Completed
Registry status
928
Enrollment target

NCT01970969: Completed study, sponsored by Scripps Translational Science Institute.

NCT01970969 is a clinical trial that has completed, run by Scripps Translational Science Institute. The registered enrollment target is 928 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01970969 has completed, sponsored by Scripps Translational Science Institute.

COMPLETED
Registry status
928 participants
Enrollment target

Study 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.

Primary Outcome

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 fibrillat

Trial Details

FieldValue
Enrollment Target 928 participants
Start Date 2013-09
Est. Completion 2017-12

What the finished NCT01970969 record still lists

NCT01970969 is an observational study that tracks outcomes without assigning an intervention. The registered 928 participants enrollment target is mid-sized for trials with a published cap.

The record links to 0 conditions, and to 0 interventions.

NCT01970969 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01970969 about?

NCT01970969 is a clinical study titled "THE GIRAFFE Study: Genomic Risk Markers for Atrial Fibrillation Following Extended Cardiac Rhythm Monitoring". 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 patie...

What is the current status of trial NCT01970969?

This trial is currently completed. The enrollment target is 928 participants. The study started on 2013-09. Estimated completion is 2017-12.

Who is sponsoring clinical trial NCT01970969?

This trial is sponsored by Scripps Translational Science Institute, which has 41 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT01970969, the US trial registry maintained by the National Library of Medicine. NCT01970969 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.