Genomic Investigation of Cardiovascular Diseases

Running, not enrolling

Conditions studied: Coronary Artery Disease, Myocardial Infarction, Atrial Fibrillation, Aortic Stenosis, Mitral Regurgitation, Idiopathic Cardiomyopathy

In brief

This proposal puts forward a research plan to initiate a genetic databank, henceforth referred to as The Genebank at Scripps Clinic Registry. This database will usher in genomic research at Scripps as we strive to stay at the forefront of cardiovascular research in the new century. Human subject donation allows for the creation of the proposed genebank.

Key facts

Study ID

NCT00722748

Run by

Scripps Translational Science Institute

People needed

15000

Starts

2007-06-01

Expected to finish

2030-09-01

Last updated by the study team

2025-01-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Candidates for this study must meet ALL of the following criteria:
• Age 18 years or older
• Be reliable, cooperative and willing to comply with all protocol-specified procedures and sub-study if consented.
• Able to understand and grant informed consent
• Have at least one of the following (a-g):
• Coronary Artery Disease (defined as):
• Coronary artery bypass surgery or
• Lesion >70% on cardiac or CT angiogram or
• Percutaneous Coronary Intervention
• Myocardial infarction (defined as):
• Diagnosed by elevated troponin level or
• Diagnosed by ST segment elevations on EKG or
• Diagnosed by pathologic Q waves on EKG or
• Documented in the medical record or by self report
• Atrial Fibrillation (defined as):
• Lone Atrial fibrillation (paroxysmal, persistent or permanent); OR
• Lone Atrial Flutter (paroxysmal, persistent or permanent)
• Automatic Internal Cardiac Defibrillator
• Aortic Stenosis (defined by):
• Calculated Aortic Valve Area ≤ 1.0 cm² or
• Mean Pressure Gradient ≥ 40 mmHg or
• Peak Pressure Gradient ≥ 64 mmHg or
• Dimensionless Index < .25 or
• Prior or planned Aortic Valve Replacement for Aortic Stenosis
• Mitral Regurgitation (insufficiency) (defined as)

You may not qualify if…

• Patients will be excluded if ANY of the following conditions apply:
• Previously enrolled in The Genebank at Scripps Clinic Registry
• Any active bleeding (i.e. GI bleed).
• Has a significant medical condition which in the investigator's opinion may interfere with the patient's optimal participation in the study
• Treatment with any investigational agents or devices within 30 days preceding enrollment in the study.
• Been administered or taken any CNS sedatives or depressants in the past 12 hours.
• Been administered or taken any CNS sedatives or depressants in the past 12 hours.
• Subject's qualifying diagnosis is Atrial fibrillation and they are known to have any one of the following:
• Prior myocardial infarction, coronary artery bypass surgery, or percutaneous coronary intervention
• EF < 45% at time of diagnosis (excluding tachycardia induced cardiomyopathy diagnosed by a cardiologist)
• Elevated left atrial pressures (> 20 mmHg)
• Dilated left atrium (> 4.0 cm or >2.0 cm/m2 body surface)
• Mitral valve disease with significant valve pathology
• Mitral regurgitation/insufficiency greater than trace to mild on echo as determined by reading physician
• Rheumatic mitral valve disease
• Congestive heart failure prior to diagnosis
• Hypertrophic cardiomyopathy
• Diagnosis following coronary artery bypass or valve replacement surgery
• Post heart transplant
• Congenital heart disease
• Diagnosed in setting of hyperthyroid
• COPD
• Obstructive sleep apnea
• Subject's qualifying diagnosis is Aortic Stenosis and they are known to have any one of the following:
• Bicuspid valve or other congenital abnormality of the aorta or aortic valve

Where it is running

• Scripps Health — La Jolla, California, United States

Full record on ClinicalTrials.gov

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