- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00321542
Coronary CT Angiography in Asymptomatic Diabetes Mellitus
Assessment of the Additive Value of Multislice Computed Tomographic Angiography of the Coronary Arteries in the Prediction of Acute Cardiac Events in Asymptomatic Individuals With Type II Diabetes Mellitus
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Patients having diabetes mellitus are at increased risk for the development of coronary heart disease. Available tests do not accurately predict which diabetic patients are at greatest risk of suffering from a coronary event. The recent development of coronary CT angiography allows non-invasive imaging of both coronary narrowing and of disease (atheroma) in the coronary arterial wall at an earlier stage of the disease before the development of coronary arterial narrowing.
In this study we will collect all the readily available patient medical data relating to diabetes and its complications and other coronary artery disease risk factors. In addition patients will be referred for exercise stress testing and for eye examinations. The coronary CT angiogram will be carefully examined for early signs of coronary artery disease. In the event of a finding on the CT scan requiring medical therapy this will be communicated to the patient and his treating physician. In the event of a finding on the stress test or CT scan requiring further medical work-up the patient will be referred to the cardiology clinic.
In general patients will be followed in the regular diabetic clinic and by their family practitioners.
In the event of any acute symptoms over the next few years possibly related to heart disease and requiring emergency room examination patients will be requested to report to the emergency room at the hospital at which the CT study was performed whenever possible.In such an event a repeat CT scan will be performed to examine if any new findings are present. In the event of any new complaints requiring referral to an out of hospital clinic patients will be referred for further assessment to the cardiology clinic and a repeat CT scan may be performed if deemed relevant.
Outcomes of all patients will be examined at 2 years or later using computerized databases. Patients undergoing hospitalization during the follow up period of at least 2-3 years will be contacted by the study staff to obtain further details of the event and hospital findings .
An analysis wil be performed of the value of CT angiography in relation to the traditional risk factors and other available medical data in the prediction of later coronary heart disease and other vascular events.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Haifa, Israel, 34362
- Lady Davis Carmel Medical Center
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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:
- Type II diabetes mellitus
- No symptoms of coronary heart disease
- At least one additional risk factor for coronary artery disease
Exclusion Criteria:
- Known coronary artery disease
- Kidney failure if more than mild
- Allergy to iodinated X-ray contrast media
- Chronic atrial fibrillation
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Death or acute myocardial infarction
Periodo de tiempo: 7 years
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7 years
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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Composite of the primary outcome and the onset of new symptoms of coronary artery disease with proven myocardial ischemia (supported by treadmill, nuclear scan or stress echo findings) or the need for a revascularization procedure.
Periodo de tiempo: 7 years
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7 years
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Director de estudio: David A Halon, MB ChB, FACC, Lady Davis Carmel Medical Center
Publicaciones y enlaces útiles
Publicaciones Generales
- Scognamiglio R, Negut C, Ramondo A, Tiengo A, Avogaro A. Detection of coronary artery disease in asymptomatic patients with type 2 diabetes mellitus. J Am Coll Cardiol. 2006 Jan 3;47(1):65-71. doi: 10.1016/j.jacc.2005.10.008. Epub 2005 Dec 9.
- Leber AW, Knez A, von Ziegler F, Becker A, Nikolaou K, Paul S, Wintersperger B, Reiser M, Becker CR, Steinbeck G, Boekstegers P. Quantification of obstructive and nonobstructive coronary lesions by 64-slice computed tomography: a comparative study with quantitative coronary angiography and intravascular ultrasound. J Am Coll Cardiol. 2005 Jul 5;46(1):147-54. doi: 10.1016/j.jacc.2005.03.071.
- Halon DA, Dobrecky-Mery I, Gaspar T, Azencot M, Yaniv N, Peled N, Lewis BS. Pulse pressure and coronary atherosclerosis in asymptomatic type 2 diabetes mellitus: a 64 channel cardiac computed tomography analysis. Int J Cardiol. 2010 Aug 6;143(1):63-71. doi: 10.1016/j.ijcard.2009.01.066. Epub 2009 Feb 25.
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 (Estimar)
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
Otros números de identificación del estudio
- CT-DM
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Medical University of South CarolinaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)TerminadoDiabetes Mellitus, Tipo 2 | Diabetes Mellitus, Tipo II | Diabetes mellitus, inicio en adultos | Diabetes mellitus, no insulinodependiente | Diabetes Mellitus, No Insulino DependienteEstados Unidos
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University of California, San FranciscoJuvenile Diabetes Research FoundationTerminadoDiabetes mellitus tipo 1 | Diabetes Mellitus, Tipo I | Diabetes mellitus insulinodependiente 1 | Diabetes Mellitus, Insulino-Dependiente, 1 | IDDMEstados Unidos, Australia
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