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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Ibrahim Atta Ibrahim, Master degree
- Telefonnummer: +201289193374
- E-Mail: attai6866@gmail.com
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
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.
Beschreibung
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).
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
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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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Bidirectional Assessment of Erectile Dysfunction and Coronary Artery Disease: Prevalence, Severity, and Clinical Correlation
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Bidirectional Assessment of Erectile Dysfunction and Coronary Artery Disease: Prevalence, Severity, and Clinical Correlation
Zeitfenster: 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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Mitarbeiter und Ermittler
Sponsor
Publikationen und hilfreiche Links
Nützliche 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
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Urogenitale Erkrankungen
- Genitalerkrankungen
- Gefäßerkrankungen
- Herz-Kreislauf-Erkrankungen
- Psychische Störungen
- Genitalerkrankungen, männlich
- Männliche Urogenitalerkrankungen
- Herzkrankheiten
- Arteriosklerose
- Arterielle Verschlusskrankheiten
- Koronare Krankheit
- Myokardischämie
- Sexuelle Dysfunktion, Physiologisch
- Sexuelle Dysfunktionen, Psychisch
- Koronare Herzkrankheit
- Erektile Dysfunktion
Andere Studien-ID-Nummern
- Association between ED and CAD
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Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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