THE GIRAFFE Study: Genomic Risk Markers for Atrial Fibrillation Following Extended Cardiac Rhythm Monitoring (GIRAFFE)
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.
Descripción general del estudio
Estado
Estado
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Tipo de estudio
Inscripción (Actual)
Inscripción
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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La Jolla, California, Estados Unidos, 92037
- Scripps Clinic
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Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
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Acepta Voluntarios Saludables
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Método de muestreo
Población de estudio
Patients defined, as high risk for atrial fibrillation will be persons with:
- 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
- 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].
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
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Número de grupos/cohortes
Cohortes e Intervenciones
Grupo / CohorteGrupo / Cohorte |
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Cardiac arrhythmia symptoms
All subjects enrolled in the study will have an iRhythm Zio patch placed and a blood sample obtained.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Association between events of Atrial Fibrillation and 4-SNP risk score
Periodo de tiempo: One time
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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%.
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One time
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Colaboradores e Investigadores
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Inicio del estudio
Inicio del estudio
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Finalización primaria
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Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Publicado por primera vez
Actualizaciones de registros de estudio
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Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
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Otros números de identificación del estudio
Otros números de identificación del estudio
- 13-6159
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