Patients With Symptoms of Cardiac Arrhythmia at Risk for Atrial FibrillationGIRAFFENCT01970969
THE GIRAFFE Study: Genomic Risk Markers for Atrial Fibrillation Following Extended Cardiac Rhythm Monitoring
An observational study of Patients With Symptoms of Cardiac Arrhythmia at Risk for Atrial Fibrillation, run by Scripps Translational Science Institute at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Symptoms of Cardiac Arrhythmia at Risk for Atrial Fibrillation
- How many people
- 928 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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].
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
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.
- Keywords
- Atrial Fibrillation, Cardiac monitoring, Genomics
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac arrhythmia symptoms | All subjects enrolled in the study will have an iRhythm Zio patch placed and a blood sample obtained. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between events of Atrial Fibrillation and 4-SNP risk score
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%.
Measured: One time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2016
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patients With Symptoms of Cardiac Arrhythmia at Risk for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 928 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scripps Translational Science Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Quest Diagnostics-Nichols Insitute
- Responsible party
- Sponsor
- Investigators
- Eric Topol, MD, Principal investigator, Scripps Translational Science Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01970969
- Sponsor's protocol ID
- 13-6159
- Acronym
- GIRAFFE
- Status last verified
- Apr 2018
- First submitted
- 8 Oct 2013
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Muse ED, Wineinger NE, Spencer EG, Peters M, Henderson R, Zhang Y, Barrett PM, Rivera SP, Wohlgemuth JG, Devlin JJ, Shiffman D, Topol EJ. Validation of a genetic risk score for atrial fibrillation: A prospective multicenter cohort study. PLoS Med. 2018 Mar 13;15(3):e1002525. doi: 10.1371/journal.pmed.1002525. eCollection 2018 Mar.
PubMed 29534064
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01970969
- Acronym / sponsor ID
- GIRAFFE / 13-6159
- Keywords
- Atrial Fibrillation, Cardiac monitoring, Genomics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 928 participants (actual)
- Lead sponsor
- Scripps Translational Science InstituteUniversity, hospital or other
- Collaborators
- Quest Diagnostics-Nichols Insitute
- Study start
- Sep 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 28 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac arrhythmia symptoms | – | –All subjects enrolled in the study will have an iRhythm Zio patch placed and a blood sample obtained. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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].
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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%.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
- Derived from this study: PubMed 29534064Muse ED, Wineinger NE, Spencer EG, Peters M, Henderson R, Zhang Y, Barrett PM, Rivera SP, Wohlgemuth JG, Devlin JJ, Shiffman D, Topol EJ. Validation of a genetic risk score for atrial fibrillation: A prospective multicenter cohort study. PLoS Med. 2018 Mar 13;15(3):e1002525. doi: 10.1371/journal.pmed.1002525. eCollection 2018 Mar.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Topol, MD principal investigator
Scripps Translational Science Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients With Symptoms of Cardiac Arrhythmia at Risk for Atrial Fibrillation, run by Scripps Translational Science Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between events of Atrial Fibrillation and 4-SNP risk score (time frame: One time). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01970969, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2018.