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NCT Number: NCT07813195

Assessment of Erectile Dysfunction and Coronary Artery Disease Severity

This study provides a comprehensive bidirectional assessment to determine the prevalence, clinical severity, and anatomical correlation between erectile dysfunction and coronary artery disease severity in patients presenting to cardiology and sexual health pathways.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Selective Coronary Angiography

Other

Diagnostic invasive coronary angiography performed to evaluate coronary anatomy, presence of stenosis, and anatomical severity scores (SYNTAX Score and Gensini Score).

Primary outcomes

  1. Bidirectional Assessment of Erectile Dysfunction and Coronary Artery Disease: Prevalence, Severity, and Clinical Correlation

    Time frame: Baseline

    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.

Secondary outcomes

  1. Bidirectional Assessment of Erectile Dysfunction and Coronary Artery Disease: Prevalence, Severity, and Clinical Correlation

    Time frame: Baseline

    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

Interested in participating?

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Trial opening soon.

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Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Bidirectional Assessment of Erectile Dysfunction and Coronary Artery Disease Severity, Prevalence and Clinical Correlation

Acronym: BA-EDCAD

Important dates

Study start
2026
Primary completion
2028
Study completion
2030
First posted
Sep 10, 2026
Registry last updated
Sep 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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