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Heart disease and erectile dysfunction: scientists look inside pelvic arteries for clues

NCT ID NCT07856199

Knowledge-focused Sponsor: Hospital Central Militar Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Oct 02, 2026 · Last updated Oct 02, 2026

Summary

Researchers are studying whether fatty plaque buildup in the internal pudendal arteries, the vessels that supply blood to the penis, is linked to erectile dysfunction in men who have or may have coronary artery disease. Sixty men undergoing a clinically needed coronary angiogram will also receive imaging of their pelvic arteries using intravascular ultrasound and near-infrared spectroscopy. The study measures the amount of lipid-rich plaque in those arteries and compares it with erectile function scores collected within 30 days. The goal is to understand the relationship between pelvic artery disease and erectile problems, and to test whether this imaging approach is safe and technically feasible.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Intravascular ultrasound and near-infrared spectroscopy imaging of the internal pudendal arteries
What this could lead to
If a link emerges between pelvic artery plaque and erectile dysfunction, doctors could one day use artery imaging to better understand or predict erectile problems in men with heart disease.
What could go wrong
This is a small, single-center exploratory study with 60 men, so it can only show associations, not cause and effect. The imaging procedure carries small risks of artery injury or bleeding, and the findings may not apply to men without coronary artery disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2026

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

atherosclerosis coronary artery disorder erectile dysfunction

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atherosclerosis Coronary artery disease Erectile dysfunction

How to take part

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  1. The places running it

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  2. The official record

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Contacts and locations

Locations

  • Hospital Central Militar

    RECRUITING

    Mexico City, Mexico City, 11200, Mexico

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