- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00021970
Modifying Oxidative Damage in WAVE - Ancillary to WAVE
Descripción general del estudio
Estado
Descripción detallada
BACKGROUND:
Supplemental vitamin E has been associated with a reduced risk of recurrent myocardial infarctions, with efficacy related to dosage and the duration of treatment. Its effects may be enhanced by vitamin C, an antioxidant that can regenerate vitamin E activity. Theoretically vitamin E and C (VitE/C) accumulate in the vascular wall with a concurrent reduction in oxidative damage, a primary feature of atherosclerotic lesions. Estrogen/hormone replacement therapy (HRT) also may reduce oxidative damage, and it may enhance the effect of vitamin E and C. These hypotheses are supported by studies defining oxidation-dependent accumulation of lipids in developing atherosclerosis; the detection of oxidative damage products, such as oxidized-LDL particles, in human atherosclerotic lesions; and clinical studies associating antioxidant or estrogen supplementation with reductions in oxidative damage cardiovascular disease. Nevertheless, no human studies have evaluated the effect of long-term VitE/C treatment, which has been reported as being the most effective prevention factor by epidemiologic studies, on specific. biochemical markers of oxidative damage and concurrently their association with recurrent cardiovascular disease. In addition, no studies have characterized the effect of long-term HRT on markers of oxidative damage or HRT's potential synergistic effect with VitE/C therapy.
DESIGN NARRATIVE:
The study assayed specific biochemical measures of oxidative damage (all markers at closeout and nitrotyrosine and chlorotyrosine also at baseline) in the Women's Angiographic Vitamin and Estrogen (WAVE) Trial, which randomized 420 38-86 year old women with a prior cardiovascular disease event to placebo, Vitamin E/C, hormone replacement therapy (HRT) or the combination of VitE/C and HRT. WAVE determined the efficacy of these treatments on quantitative angiographic evaluation of minimal coronary artery diameter performed at baseline and at the final visit to be completed during the first 10 months of 2001. The ancillary study measured oxidation products from several classes of compounds (lipids by F2-isoprostanes, proteins by nitrotyrosine and chlorotyrosine, and DNA by 8-hydroxy-2'-deoxyguanosine), thereby studying several major pathways that may lead to atherogenesis. In addition, inflammation with C-reactive protein, platelet activation with p-selectin, altered lipid metabolism with a lipid profile and other characteristics of the study population were integrated into the assessment of oxidative damage in WAVE. By measuring these various factors and by assessing oxidative damage in several classes of compounds, the authors tested the relationships among specific pathways of oxidative damage, supplemental VitE/C and/or HRT and other risk factors upon the progression of established macrovascular disease.
Tipo de estudio
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Michael Steffes, University of Minnesota
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización del estudio
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 979
- R01HL068397 (Subvención/contrato del NIH de EE. UU.)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Enfermedades cardíacas
-
Region SkaneInscripción por invitaciónInsuficiencia cardíaca New York Heart Association (NYHA) Clase II | Insuficiencia cardíaca New York Heart Association (NYHA) Clase IIISuecia
-
Medical University of BialystokInstitute of Cardiology, Warsaw, Poland; Medical University of Lodz; Poznan University... y otros colaboradoresAún no reclutandoInsuficiencia Cardíaca Sistólica | Insuficiencia cardíaca con fracción de eyección reducida | Insuficiencia cardíaca Clase IV de la New York Heart Association | Insuficiencia cardíaca Clase III de la New York Heart AssociationPolonia
-
Novartis PharmaceuticalsTerminadoPacientes que completaron con éxito el período de tratamiento de 12 meses del estudio principal (receptores de Novo Heart) que estaban interesados en recibir tratamiento con EC-MPS
-
University of WashingtonAmerican Heart AssociationTerminadoInsuficiencia cardíaca, congestiva | Alteración mitocondrial | Insuficiencia cardíaca Clase IV de la New York Heart AssociationEstados Unidos