Pudendal artery plaque and erectile dysfunction in men with heart disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective single-center study measures both pudendal artery plaque burden and erectile function to see if there is a relationship in men with documented or suspected coronary artery disease. The technique uses IVUS-NIRS imaging during selective pudendal angiography after the coronary procedure, followed by IIEF-5 assessment within 30 days. Primary analysis looks at how pudendal lipid-rich plaque (maxLCBI4mm) relates to erectile function scores. Secondary analyses explore pudendal and coronary plaque relationships and other vascular factors. The study is exploratory and involves invasive imaging with careful eligibility screening and informed consent.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Male participants aged 18 years or older.
2. Documented or suspected coronary artery disease with a clinical indication for coronary angiography.
3. Coronary IVUS-NIRS evaluation indicated by the treating interventional cardiologist.
4. Sufficient clinical and hemodynamic stability to undergo the additional pudendal evaluation.
5. Favorable pelvic vascular anatomy for selective angiography and safe advancement of the IVUS-NIRS catheter.
6. Ability to complete the IIEF-5 questionnaire and provide information regarding sexual function.
7. Written informed consent specifically for study participation and invasive evaluation of the internal pudendal arteries.
8. Agreement to clinical follow-up by Cardiology and Urology.

Exclusion Criteria:

1. Cardiogenic shock, hemodynamic instability, or acute clinical deterioration.
2. Urgent or complicated coronary procedure in which prolonging the procedure would increase risk.
3. Advanced kidney disease or high risk of kidney injury associated with additional contrast administration.
4. Unfavorable iliofemoral or pelvic vascular anatomy for safe evaluation of the internal pudendal arteries.
5. Severe coagulopathy, active bleeding, or contraindication to the invasive procedure.
6. History of radical pelvic surgery or pelvic radiotherapy.
7. Advanced prostate cancer or previous urologic treatment that predominantly explains erectile dysfunction.
8. Severe untreated hypogonadism, advanced neurologic disease, or another predominant nonvascular cause of erectile dysfunction.
9. Inability to reliably complete the IIEF-5 questionnaire.
10. Refusal to participate or to provide study-specific written informed consent.

Where it's running

• Hospital Central Militar
  Mexico City, Mexico City, Mexico Recruiting

Study contacts

• Principal investigator: José Raúl Méndez Colin, MD — Hospital Central Militar
• Study coordinator: José Raúl Méndez Colin, MD
• Email: dr.mendezcolin1989@gmail.com
• Phone: +52 55 2516 3465

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.