Erectile Dysfunction and Coronary Artery DiseaseBA-EDCADNCT07813195
Assessment of Erectile Dysfunction and Coronary Artery Disease Severity
An observational study of Erectile Dysfunction and Coronary Artery Disease, run by Assiut University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Erectile Dysfunction and Coronary Artery Disease
- What is being tested?
- Selective Coronary Angiography
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Aug 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Being tested
- Selective Coronary Angiography
- Keywords
- Association between ED and CAD
- Medical subject headings
- Erectile Dysfunction, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective Coronary AngiographyOther
Diagnostic invasive coronary angiography performed to evaluate coronary anatomy, presence of stenosis, and anatomical severity scores (SYNTAX Score and Gensini Score).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Selective Coronary Angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bidirectional Assessment of Erectile Dysfunction and Coronary Artery Disease: Prevalence, Severity, and Clinical Correlation
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.
Measured: Baseline
Secondary outcomes (1)
Bidirectional Assessment of Erectile Dysfunction and Coronary Artery Disease: Prevalence, Severity, and Clinical Correlation
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile Dysfunction and Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibrahim Atta Ibrahim Btales, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07813195
- Sponsor's protocol ID
- Association between ED and CAD
- Acronym
- BA-EDCAD
- Status last verified
- Sep 2026
- First submitted
- 20 Aug 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bidirectional Assessment of Erectile Dysfunction and Coronary Artery Disease Severity, Prevalence and Clinical Correlation
- ClinicalTrials.gov ID
- NCT07813195
- Acronym / sponsor ID
- BA-EDCAD / Association between ED and CAD
- Keywords
- Association between ED and CAD
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 10 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Coronary Artery Disease (CAD) Cohort | – | Other: Selective Coronary AngiographyMale 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Selective Coronary AngiographyDiagnostic invasive coronary angiography performed to evaluate coronary anatomy, presence of stenosis, and anatomical severity scores (SYNTAX Score and Gensini Score). | Other | Coronary Artery Disease (CAD) Cohort |
Primary outcome
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.
1 secondary outcome
Bidirectional Assessment of Erectile Dysfunction and Coronary Artery Disease: Prevalence, Severity, and Clinical Correlation
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- 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), 968-978Link provided by the sponsor.
- 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), 721-7Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Erectile Dysfunction and Coronary Artery Disease, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ibrahim Atta Ibrahim, Master degree (+201289193374, attai6866@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bidirectional Assessment of Erectile Dysfunction and Coronary Artery Disease: Prevalence, Severity, and Clinical Correlation (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.