- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00722748
Genomic Investigation of Cardiovascular Diseases
The Genebank at Scripps Clinic Registry
Descripción general del estudio
Estado
Descripción detallada
The completion of the human genome project within the final months of the previous millennium, is a landmark of scientific accomplishment. This achievement heralds the importance human and molecular genetics will play in the coming century in medicine. In short, one expects that dissecting the phenotypic aspects of disease to a culprit mutation/variation of a gene or collection of genes, will modify and or augment our present diagnostic ability leading on to new therapeutic interventions that are targeted based on these discoveries.
The broad application of human genetics will progress from the study of rare mendelian traits with complete penetrance compiled over the last 3-4 decades to a large number of "common" diseases that have multi-gene etiology with variable penetrance such as non-insulin dependent diabetes mellitus and hypertension. Cardiology will probably stay at a forefront of this transformation, as cardiovascular diseases (CVD) remain the major source of morbidity and mortality in developing countries, and is fast reaching the same status in the underdeveloped countries. Furthermore, the track record of rapid adaptation of new technology and research in the field of cardiology, would give further impetus to this transition. In the midst of these dynamic currents, 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.
The objective of this study is, to obtain blood samples in order to define genes for various cardiovascular conditions. The blood samples will go through DNA analysis and noted for 1 million SNP's per individual.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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La Jolla, California, Estados Unidos, 92037
- Scripps Health
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
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).
Exclusion Criteria:
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
- Evidence of Rheumatic involvement of the Aortic Valve
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)
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Genebank
By creating a genebank from patient's blood donations we will ultimately be able to define genes for various cardiovascular conditions.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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38 cc of blood obtained for DNA analysis. Medical information -diagnosis, disease history, medical treatments, response to treatments, laboratory tests, subject's age, ethnic background, and if available, related family history.
Periodo de tiempo: At the time of informed consent
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At the time of informed consent
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Isquemia
- Procesos Patológicos
- Necrosis
- Isquemia miocardica
- Enfermedades cardíacas
- Enfermedades cardiovasculares
- Enfermedades Vasculares
- Arteriosclerosis
- Enfermedades arteriales oclusivas
- Arritmias Cardiacas
- Enfermedad de la válvula aórtica
- Enfermedades de las válvulas cardíacas
- Obstrucción del flujo de salida ventricular
- Enfermedad coronaria
- Infarto de miocardio
- Infarto
- Enfermedad de la arteria coronaria
- Fibrilación auricular
- Estenosis de la válvula aórtica
- Insuficiencia de la válvula mitral
- Miocardiopatías
Otros números de identificación del estudio
- HSC004714
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