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
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: Ibrahim Atta Ibrahim, Master degree
- Telefoonnummer: +201289193374
- E-mail: attai6866@gmail.com
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Bemonsteringsmethode
Studie Bevolking
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.
Beschrijving
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).
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
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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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Bidirectional Assessment of Erectile Dysfunction and Coronary Artery Disease: Prevalence, Severity, and Clinical Correlation
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Bidirectional Assessment of Erectile Dysfunction and Coronary Artery Disease: Prevalence, Severity, and Clinical Correlation
Tijdsspanne: 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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Medewerkers en onderzoekers
Sponsor
Publicaties en nuttige links
Nuttige links
- 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
Studie record data
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Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
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Eerst ingediend dat voldeed aan de QC-criteria
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Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Urogenitale ziekten
- Genitale ziekten
- Vaatziekten
- Hart-en vaatziekten
- Psychische aandoening
- Genitale ziekten, man
- Mannelijke urogenitale ziekten
- Hartziekten
- Arteriosclerose
- Arteriële occlusieve ziekten
- Hart-en vaatziekte
- Myocardiale ischemie
- Seksuele disfunctie, fysiologisch
- Seksuele disfuncties, psychisch
- Coronaire hartziekte
- Erectiestoornissen
Andere studie-ID-nummers
- Association between ED and CAD
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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