Assessment of Erectile Dysfunction and Coronary Artery Disease Severity (BA-EDCAD)

September 8, 2026 updated by: Ibrahim Atta Ibrahim Btales, Assiut University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ibrahim Atta Ibrahim, Master degree
  • Phone Number: +201289193374
  • Email: attai6866@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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:

  1. Patients presenting with cardiogenic shock, unstable hemodynamics.
  2. Primary psychogenic, endocrinological (except diabetes mellitus), or neurogenic erectile dysfunction.
  3. Prior history of pelvic surgery, pelvic trauma, or radical prostatectomy.
  4. Severe hepatic failure, end-stage renal disease on dialysis, or active malignancies.
  5. Decompensated heart failure (NYHA Class III or IV).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: Selective Coronary Angiography
Diagnostic invasive coronary angiography performed to evaluate coronary anatomy, presence of stenosis, and anatomical severity scores (SYNTAX Score and Gensini Score).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2030

Study Registration Dates

First Submitted

August 20, 2026

First Submitted That Met QC Criteria

September 8, 2026

First Posted (Actual)

September 10, 2026

Study Record Updates

Last Update Posted (Actual)

September 10, 2026

Last Update Submitted That Met QC Criteria

September 8, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Association between ED and CAD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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