Hormones and Sexual Function Predict Outcomes in Revascularized Men With Diabetes (HEART-MEND)
Descripción general del estudio
Estado
Descripción detallada
Diabetes mellitus (DM) and multi-vessel coronary artery disease (CAD) entail significant risk for progression of cardiac morbidity and mortality. Compelling recent research points to biological pathways that link DM and CAD to androgen status and sexual function. We hypothesize that androgen deficiency (AD) and erectile dysfunction (ED) independently serve as sentinel indicators, predicting the future development of adverse cardiovascular and cerebrovascular events in men with diabetes following coronary revascularization.
ED is emerging as a barometer of overall endothelial function. We hypothesize that as a consequence of this relationship, erectile dysfunction is predictive of cardiovascular outcomes in men with diabetes and CAD. We also propose that AD affects morbidity and mortality in men with DM and CAD by influencing presentation and progression of endothelial dysfunction as well as inflammation and hemostasis.
We propose to investigate four specific aims using 1,143 diabetic men who have angiographically proven coronary artery disease (CAD) (≥50%) in at least one major epicardial vessel with or without percutaneous coronary intervention (PCI). Specific aims of this study are: 1) To determine whether androgen status at baseline independently predicts primary and secondary endpoints in men (n=1,143) with DM and CAD. 2) To determine whether erectile dysfunction at baseline independently predicts cardiovascular outcomes in men with DM and CAD. 3) To determine whether change of androgen status and sexual function over time independently predict cardiovascular outcomes in men with DM and CAD. 4) To demonstrate specific mediators and pathways that link sexual function and androgen status to cardiovascular disease.
The primary endpoint is defined as the combined all-cause mortality, non-fatal myocardial infarction (MI), and stroke. Secondary endpoints include major adverse cardiovascular and cerebrovascular events (MACCE), defined as death, nonfatal MI, stroke or revascularization at one year and angina status as evaluated with the Seattle Angina Questionnaire (SAQ) at 6 months, 12 months, 18 months, 24 months, 30 months and 36 months following catheterization.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
New Jersey
-
Guttenberg, New Jersey, Estados Unidos, 07093
- Hudson Heart Group
-
-
New York
-
Elmhurst, New York, Estados Unidos, 11373
- Elmhurst Hospital
-
Mineola, New York, Estados Unidos, 11501
- Winthorp University Hospital
-
New York, New York, Estados Unidos, 10029
- Icahn School of Medicine at Mount Sinai
-
Stony Brook, New York, Estados Unidos, 11794
- Stony Brook University Hospital
-
-
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:
- Male age [18-75 years];
- Type 2 Diabetes, defined according to the American Diabetes Association as history of: a) presence of classic symptoms of DM with unequivocal elevation of plasma glucose (2-hour post-prandial or random of >200 mg/dL (11mmol/L), b) fasting plasma glucose elevation on more than 1 occasion of at least 126 mg/dL (7mmol/L) or c) HA1C > 6.5, currently undergoing pharmacological or non-pharmacological treatment;
- Angiographically confirmed Coronary Artery Disease (≥50%) with or without PCI;
- Indication for revascularization based upon symptoms of angina and/or objective evidence of myocardial ischemia;
- Willingness to comply with all follow-up required study visits; and
- Signed and received copy of informed consent
Exclusion Criteria:
- Severe congestive heart failure (class III or IV according to NYHA, or pulmonary edema) at the time of enrollment;
- Previous stroke within 6 months;
- Prior history of significant bleeding (within the previous 6 months) that might be expected to occur during PCI/DES related anticoagulation;
- Acute ST-elevation MI (Q-wave) within 72 hours prior to enrollment requiring revascularization;
- Abnormal creatine kinase (CK > 2x normal); or abnormal CK-MB levels at time of randomization;
- Contraindication to either CABG or PCI/DES because of a coexisting clinical condition];
- Significant leukopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis;
- Intolerance or contraindication to aspirin or both clopidogrel and ticlopidine;
- Dementia with a Mini Mental Status Examination (MMSE) score of <20;
- Extra-cardiac illness that is expected to limit survival to less than 5 years (e.g. oxygen-dependent chronic obstructive pulmonary disease, active hepatitis or significant hepatic failure, severe renal disease);
- Geographically inaccessible for follow-up visits required by protocol.
- Additional Ancillary Study Exclusions. Exclusion criteria that are unique to the proposed study are prior use of hormonal therapy (HRT) with testosterone in men at baseline and current use of sex-hormone antagonist medications at baseline.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Grupo
- Perspectivas temporales: Futuro
Cohortes e Intervenciones
Grupo / Cohorte |
|---|
|
Coronary Artery Disease (≥50%) with or without PCI
We propose to investigate four specific aims using 1,143 diabetic men who have CAD (≥50%) lesion in at least one major epicardial vessel with or without PCI.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Composite outcome of all-cause mortality
Periodo de tiempo: up to 3 Years
|
The primary outcome is time to composite outcome of all-cause mortality, MI or stroke.
|
up to 3 Years
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
To determine whether androgen status at baseline independently predicts primary and secondary endpoints in men (n=1,143) with DM and CAD.
Periodo de tiempo: Baseline
|
Androgen profile consists of total, free, and bio-available testosterone (T) and testosterone:estradiol ratio.
Hypothesis: AD at baseline (defined by total T < 300 ng/dl) will be an independent predictor of primary and secondary outcomes.
|
Baseline
|
|
To determine whether erectile dysfunction at baseline independently predicts cardiovascular outcomes in men with DM and CAD.
Periodo de tiempo: Baseline
|
ED severity will be determined using the International Index of Erectile Function (IIEF), a standard instrument that is available in multiple translations and has excellent cross-cultural validity. Hypothesis: Severe ED at baseline (IIEF < 11), while controlling for demographic and clinical covariates, will be an independent predictor of primary and secondary cardiac outcomes. |
Baseline
|
|
MACCE
Periodo de tiempo: at 6 months following catheterization
|
Secondary endpoints include major adverse cardiovascular and cerebrovascular events (MACCE), defined as death, nonfatal MI, stroke or revascularization at one year and angina status as evaluated with the Seattle Angina Questionnaire (SAQ) at 6, 12, 18, 24, 30 and 36 months following catheterization.
|
at 6 months following catheterization
|
|
MACCE
Periodo de tiempo: at 12 months following catheterization
|
Secondary endpoints include major adverse cardiovascular and cerebrovascular events (MACCE), defined as death, nonfatal MI, stroke or revascularization at one year and angina status as evaluated with the Seattle Angina Questionnaire (SAQ) at 6, 12, 18, 24, 30 and 36 months following catheterization.
|
at 12 months following catheterization
|
|
MACCE
Periodo de tiempo: at 18 months following catheterization
|
Secondary endpoints include major adverse cardiovascular and cerebrovascular events (MACCE), defined as death, nonfatal MI, stroke or revascularization at one year and angina status as evaluated with the Seattle Angina Questionnaire (SAQ) at 6, 12, 18, 24, 30 and 36 months following catheterization.
|
at 18 months following catheterization
|
|
MACCE
Periodo de tiempo: at 24 months following catheterization
|
Secondary endpoints include major adverse cardiovascular and cerebrovascular events (MACCE), defined as death, nonfatal MI, stroke or revascularization at one year and angina status as evaluated with the Seattle Angina Questionnaire (SAQ) at 6, 12, 18, 24, 30 and 36 months following catheterization.
|
at 24 months following catheterization
|
|
MACCE
Periodo de tiempo: at 30 months following catheterization
|
Secondary endpoints include major adverse cardiovascular and cerebrovascular events (MACCE), defined as death, nonfatal MI, stroke or revascularization at one year and angina status as evaluated with the Seattle Angina Questionnaire (SAQ) at 6, 12, 18, 24, 30 and 36 months following catheterization.
|
at 30 months following catheterization
|
|
MACCE
Periodo de tiempo: at 36 months following catheterization
|
Secondary endpoints include major adverse cardiovascular and cerebrovascular events (MACCE), defined as death, nonfatal MI, stroke or revascularization at one year and angina status as evaluated with the Seattle Angina Questionnaire (SAQ) at 6, 12, 18, 24, 30 and 36 months following catheterization.
|
at 36 months following catheterization
|
Colaboradores e Investigadores
Patrocinador
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
Palabras clave
Términos MeSH relevantes adicionales
- Desordenes mentales
- Enfermedades cardíacas
- Enfermedades cardiovasculares
- Enfermedades Vasculares
- Trastornos del metabolismo de la glucosa
- Enfermedades metabólicas
- Arteriosclerosis
- Enfermedades arteriales oclusivas
- Enfermedades del sistema endocrino
- Disfunciones Sexuales Psicológicas
- Disfunción Sexual Fisiológica
- Enfermedad de la arteria coronaria
- Isquemia miocardica
- Enfermedad coronaria
- Diabetes mellitus
- Disfuncion erectil
Otros números de identificación del estudio
- GCO 06-0648
- R01DK077954 (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. .