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- Ensayo clínico NCT07813195
Assessment of Erectile Dysfunction and Coronary Artery Disease Severity (BA-EDCAD)
Bidirectional Assessment of Erectile Dysfunction and Coronary Artery Disease Severity, Prevalence and Clinical Correlation
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Erectile dysfunction (ED) and coronary artery disease (CAD) share a common pathophysiological substrate predominantly driven by systemic endothelial dysfunction, vascular inflammation, and atherosclerosis. Under the "artery size hypothesis," atherosclerotic plaque accumulation leads to clinical symptoms earlier in smaller vessels than in larger ones. Because penile cavernosal arteries are smaller in diameter (1-2 mm) compared to the proximal left anterior descending coronary artery (3-4 mm), lumen obstruction typically manifests as erectile impairment before overt coronary symptoms surface.
Consequently, assessing erectile health provides a critical non-invasive window into systemic vascular disease and serves as an early clinical marker for cardiovascular risk stratification. The 2021 European Society of Cardiology (ESC) Guidelines on cardiovascular disease prevention explicitly mandate evaluating organic ED as an independent risk modifier for silent cardiovascular disease.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Ibrahim Atta Ibrahim, Master degree
- Número de teléfono: +201289193374
- Correo electrónico: attai6866@gmail.com
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
The study population consists of male patients aged 18 to 50 years who present with erectile dysfunction secondary to diabetes mellitus or cardiovascular-related etiology, undergoing clinical evaluation and sexual health assessment in an outpatient setting.
Participants are drawn from eligible patients presenting for routine or specialized cardiovascular and medical care who meet the predefined age and clinical eligibility criteria. The population excludes individuals with primary psychogenic, endocrinological (excluding diabetes mellitus), or neurogenic erectile dysfunction, as well as those with severe systemic comorbidities including cardiogenic shock, hemodynamically unstable cardiovascular disease, NYHA Class III or IV decompensated heart failure, severe hepatic failure, end-stage renal disease on dialysis, active malignancies, or prior history of pelvic trauma/radical prostatectomy.
Descripción
Inclusion Criteria:
1 - Male patients aged between 18 and 50 years. 2-Patients undergoing primary or diagnostic coronary angiography due to suspected or confirmed acute, chronic coronary syndrome or stable angina.
3-Patients providing written informed consent to participate in the study and discuss sexual health assessments.
Exclusion Criteria:
- Patients presenting with cardiogenic shock, unstable hemodynamics.
- Primary psychogenic, endocrinological (except diabetes mellitus), or neurogenic erectile dysfunction.
- Prior history of pelvic surgery, pelvic trauma, or radical prostatectomy.
- Severe hepatic failure, end-stage renal disease on dialysis, or active malignancies.
- Decompensated heart failure (NYHA Class III or IV).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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Coronary Artery Disease (CAD) Cohort
Male patients aged 18-50 undergoing diagnostic or primary coronary angiography for suspected or confirmed acute or chronic coronary syndromes.
Patients are evaluated for erectile dysfunction prevalence and severity using the Arabic-validated IIEF-5 questionnaire, with those showing severe ED undergoing pharmaco-penile duplex ultrasonography.
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Diagnostic invasive coronary angiography performed to evaluate coronary anatomy, presence of stenosis, and anatomical severity scores (SYNTAX Score and Gensini Score).
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Bidirectional Assessment of Erectile Dysfunction and Coronary Artery Disease: Prevalence, Severity, and Clinical Correlation
Periodo de tiempo: Baseline
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To determine the prevalence and clinical severity of erectile dysfunction (using the International Index of Erectile Function-5, IIEF-5) in patients diagnosed with coronary artery disease undergoing coronary angiography, and conversely, to assess the prevalence and anatomical severity of CAD in patients presenting with vasculogenic severe ED.
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Baseline
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Bidirectional Assessment of Erectile Dysfunction and Coronary Artery Disease: Prevalence, Severity, and Clinical Correlation
Periodo de tiempo: Baseline
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To correlate the severity of ED (IIEF-5 score) with the anatomical complexity and severity of CAD evaluated by coronary angiography (using the SYNTAX score or Gensini score). To evaluate echocardiographic parameters (e.g., left ventricular ejection fract |
Baseline
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Enlaces Útiles
- Gandaglia, G., Briganti, A., Jackson, G., Kloner, R. A., Montorsi, F., Montorsi, P., & Vlachopoulos, C. (2014). A systematic review of the association between erectile dysfunction and cardiovascular disease. European Urology, 65(5), 968-978
- Montorsi, P., Ravagnani, P. M., Galli, S., Rotatori, F., Veglia, F., Briganti, A., & Montorsi, F. (2006). Association between erectile dysfunction and coronary artery disease: matching the right patient with the right test. European Urology, 50(4), 721-7
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
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
- Enfermedades urogenitales
- Enfermedades Genitales
- Enfermedades Vasculares
- Enfermedades cardiovasculares
- Desordenes mentales
- Enfermedades Genitales Masculinas
- Enfermedades urogenitales masculinas
- Enfermedades cardíacas
- Arteriosclerosis
- Enfermedades arteriales oclusivas
- Enfermedad coronaria
- Isquemia miocardica
- Disfunción Sexual Fisiológica
- Disfunciones Sexuales Psicológicas
- Enfermedad de la arteria coronaria
- Disfuncion erectil
Otros números de identificación del estudio
- Association between ED and CAD
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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