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NCT00722748Active, not recruiting

Genomic Investigation of Cardiovascular Diseases

The Genebank at Scripps Clinic Registry

Source: ClinicalTrials.gov · Last updated 16 Jan 2025

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
15000 (estimated)
First submitted
24 Jul 2008
Start date
Jun 2007
Primary completion date
Sept 2025
Lead sponsor
Scripps Translational Science Institute
NCT number
NCT00722748

What you commit to

  • Study type: Observational
  • Planned participants: 15000
  • From Jun 2007 to the primary completion date, Sept 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previously enrolled in The Genebank at Scripps Clinic Registry
  • Treatment with any investigational agents or devices within 30 days preceding enrollment in the study.
  • 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 Idiopathic (non-ischemic) cardiomyopathy and they are known to have any one of the following:
    • Ischemic cardiomyopathy
    • Hypertrophic cardiomyopathy
    • Viral cardiomyopathy
    • Alcohol/drug induced cardiomyopathy

Other illness

  • Patients will be excluded if ANY of the following conditions apply:
  • 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

Lab values

  • Subject's qualifying diagnosis is Mitral regurgitation (insufficiency) and they are known to have any one of the following:
    • Ejection fraction \<50%
    • Evidence of significant ischemic disease with regions of akinetic myocardium
    • Rheumatic changes on echocardiogram (as determined by the reading physi4ian)
    • 5\. Significant Mitral stenosis (greater than "mild" on echocardiogram as determined by the reading physician) 6. Evidence of valve perforation 7. Evidence of congenital abnormality (i.e. cleft valve)

Other

  • 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 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
    • Evidence of Rheumatic involvement of the Aortic Valve

Who the study is looking for

  • 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)
    • Moderate to Severe (equivalent to +3 to +4) mitral regurgitation (insufficiency) on transthoracic echocardiogram as determined by the reading physician and structurally abnormal valve (i.e. myxomatous) and/or thickened or redundant leaflets; OR
    • Prior or planned Mitral Valve repair or replacement for mitral regurgitation
    • Idiopathic (non-ischemic) Cardiomyopathy (defined as):
    • Diagnosed \< age 40; OR
    • Non-ischemic etiology confirmed by cardiac angiography or CT angiography (may have non-obstructive or stable coronary artery disease if diagnosis of non-ischemic etiology of CM is established by cardiologist).

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Scripps Health
Coordinator of this site? Confirm its status
La JollaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.