- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00481806
Evaluating the Role of Thrombin in Saphenous Vein Graft Failure After Heart Bypass Surgery
Thrombin Dysregulation Leads to Early Saphenous Vein Graft Failure
Descripción general del estudio
Estado
Condiciones
Descripción detallada
The saphenous vein, which runs from the ankle to the groin along the inside of the leg, is commonly used as a graft for people undergoing a CABG surgery. The vein is removed from the leg and reattached to the heart to create a detour around the blocked part of a coronary artery. Following this procedure, many people are prescribed aspirin as a way to increase the chance that the graft procedure will be successful. However, saphenous vein graft failure may still occur in some people, indicating a need to understand why this happens and who might be at risk for graft failure. Thrombin, a protein involved in the blood clotting process, is somehow related to aspirin resistance, abnormalities in blood flow, and cell disruption within the saphenous vein, all factors thought to increase the risk of graft failure. The purpose of this study is to evaluate the likelihood that a burst in thrombin contributes to graft failure in people who have recently undergone a CABG procedure using the saphenous vein.
This study will enroll individuals undergoing CABG surgery at the University of Maryland. Prior to and immediately following surgery, an incision will be made in the skin and the time required for the blood to form a clot will be determined. During surgery, participants' blood vessels will be examined using imaging and cell analysis techniques. Blood collection will occur before surgery, immediately after surgery, and on Days 1, 3, and 30 following surgery. A portion of blood will be frozen for future analysis. An x-ray of the saphenous vein will be performed on Day 5 and again at a follow-up visit 6 to 12 months following surgery. Kidney function will be measured at both of these visits prior to the x-ray procedure. At the second visit, health and mental status questionnaires will be completed.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Arizona
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Tucson, Arizona, Estados Unidos, 85724
- Reclutamiento
- University of Arizona College of Medicine
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Investigador principal:
- Robert S. Poston, MD
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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:
- Scheduled for CABG surgery at University of Arizona University Medical Center (UMC)
- For females, willing to use a reliable form of birth control for the duration of the study
Exclusion Criteria:
- Non-dermatologic allergy to intravenous (IV) radiographic contrast
- Creatinine levels greater than 2.0 mg/dL
- Pregnant
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Solo caso
- Perspectivas temporales: Futuro
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Amplifying the severity of all three risk factors of Virchow's triad is expected to lead to a synergistic increase in regional thrombin formation
Periodo de tiempo: Measured at 5 years
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Measured at 5 years
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Pressure distention is the main stimulus that creates a loss of thrombin control within the SVG
Periodo de tiempo: Measured at 5 years
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Measured at 5 years
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Accurate tests of graft quality will be developed that provide rapid results for ready translation into clinical applications
Periodo de tiempo: Measured at 5 years
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Measured at 5 years
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Aprotinin or bivalirudin will effectively suppress thrombin generation and its effects within the highest risk grafts
Periodo de tiempo: Measured at 5 years
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Measured at 5 years
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Robert S. Poston, MD, University of Arizona, Tucson
Publicaciones y enlaces útiles
Publicaciones Generales
- Desai P, Kiani S, Thiruvanthan N, Henkin S, Kurian D, Ziu P, Brown A, Patel N, Poston R. Impact of the learning curve for endoscopic vein harvest on conduit quality and early graft patency. Ann Thorac Surg. 2011 May;91(5):1385-91; discussion 1391-2. doi: 10.1016/j.athoracsur.2011.01.079.
- Poston RS, Tran R, Collins M, Reynolds M, Connerney I, Reicher B, Zimrin D, Griffith BP, Bartlett ST. Comparison of economic and patient outcomes with minimally invasive versus traditional off-pump coronary artery bypass grafting techniques. Ann Surg. 2008 Oct;248(4):638-46. doi: 10.1097/SLA.0b013e31818a15b5.
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
- 479
- R01HL084080-01A1 (Subvención/contrato del NIH de EE. UU.)
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