- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00017836
Mechanisms Linking Depression to Cardiovascular Risk
Descripción general del estudio
Estado
Descripción detallada
BACKGROUND:
Multiple studies have demonstrated a higher risk of cardiovascular disease and worse cardiovascular disease (CVD) prognosis associated with depression that appear to synergistically and significantly adversely impact health. Because these initial studies are observational, much work remains to understand this area. If these conditions are mechanistically inter-related, identification of both conditions in the same subject may provide a means of enhancing risk stratification and most appropriately targeting therapy. If the interaction between the conditions is causal not simply associative, appropriate therapy interventions can be designed and tested.
DESIGN NARRATIVE:
The project is designed to clarify the role of depression on CVD risk by using a co-twin study design. The study will examine twin pairs from the Vietnam Era Twin Registry (VET). Twin pairs will be invited to participate if they meet two criteria: (1) neither has a history of CVD as of 1990 and (2) one twin is diagnosed with depression as of 1992. The study investigates the effects of depression on two indicators of "early" CVD: coronary flow reserve, assessed by means of Positron Emission Tomography (PET) myocardial infusion imaging; and heart rate variability (HRV) assessed by ambulatory electrocardiographic monitoring. It is hypothesized that within each pair, the twins who have clinical depression will exhibit lower coronary vascular reserve and lower heart rate variability compared with their co-twins without a history of depression. Moreover, by comparing the size of the intra-pair difference in these parameters between depression discordant monozygotic and dizygotic twins an estimate of the relative contributions of gene and environmental factors can be ascertained. In addition to the PET and HRV assessments, subjects will complete the Statistical Clinical Interview of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV SCID) to document a history of depression, a psychometric battery including the Early Trauma Inventory and Hamilton Depression Scale, and such risk factors as cigarette smoking, physical activity, blood pressure and blood lipids, glucose and insulin, indices of inflammation and thrombogenicity including levels of reactive protein C, fibrinogen, and P-selectin, and neurohormones such as adrenocorticotropic hormone, cortisol, and dehydroepiandrosterone sulphate.
Tipo de estudio
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Plan de estudios
¿Cómo está diseñado el estudio?
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Viola Vaccarino, Emory University
Publicaciones y enlaces útiles
Publicaciones Generales
- Eufinger SC, Votaw J, Faber T, Ziegler TR, Goldberg J, Bremner JD, Vaccarino V. Habitual dietary sodium intake is inversely associated with coronary flow reserve in middle-aged male twins. Am J Clin Nutr. 2012 Mar;95(3):572-9. doi: 10.3945/ajcn.111.018077. Epub 2012 Jan 18.
- Karohl C, Su S, Kumari M, Tangpricha V, Veledar E, Vaccarino V, Raggi P. Heritability and seasonal variability of vitamin D concentrations in male twins. Am J Clin Nutr. 2010 Dec;92(6):1393-8. doi: 10.3945/ajcn.2010.30176. Epub 2010 Oct 13.
- Dai J, Ziegler TR, Bostick RM, Manatunga AK, Jones DP, Goldberg J, Miller A, Vogt G, Wilson PW, Jones L, Shallenberger L, Vaccarino V. High habitual dietary alpha-linolenic acid intake is associated with decreased plasma soluble interleukin-6 receptor concentrations in male twins. Am J Clin Nutr. 2010 Jul;92(1):177-85. doi: 10.3945/ajcn.2010.29305. Epub 2010 May 12.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
- IRB00024823
- 970 (Otro identificador: NIH ID)
- R01HL068630 (Subvención/contrato del NIH de EE. UU.)
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