RECRUITING Not applicable ClinicalTrials.gov

Pudendal Atherosclerosis by IVUS-NIRS in Men With Coronary Artery Disease

Sponsor: Hospital Central Militar • ClinicalTrials.gov ID: NCT07856199

Registry updated: 2026-10-02

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Description

This prospective, single-center, exploratory study will evaluate the association between atherosclerotic and lipid plaque burden in the internal pudendal arteries, assessed by intravascular ultrasound and near-infrared spectroscopy (IVUS-NIRS), and the severity of erectile dysfunction in adult men with documented or suspected coronary artery disease undergoing clinically indicated coronary angiography. After completion of the clinically indicated coronary procedure, eligible and hemodynamically stable participants with favorable pelvic vascular anatomy will undergo selective pudendal angiography and investigational IVUS-NIRS imaging of one or both internal pudendal arteries. Erectile function will subsequently be assessed within 30 days using the 5-item International Index of Erectile Function (IIEF-5). The primary outcome will be the correlation between pudendal maxLCBI4mm and IIEF-5 score. Secondary analyses will characterize pudendal and coronary plaque burden, assess the relationship between pudendal and coronary lipid burden, evaluate associations with cardiovascular risk factors, and describe the technical feasibility and safety of pudendal IVUS-NIRS imaging.

Interventions

Selective Pudendal Angiography (Procedure)
Selective angiography of the internal iliac and internal pudendal arteries will be performed after completion of the clinically indicated coronary procedure to assess pelvic vascular anatomy and technical feasibility for intravascular imaging.
Pudendal IVUS-NIRS Imaging (Device)
When vascular anatomy and clinical conditions are considered suitable, an IVUS-NIRS catheter will be advanced into one or both internal pudendal arteries. Automated pullback imaging will be performed to assess vessel anatomy, plaque burden, lipid core burden index (LCBI), and maxLCBI4mm.

Eligibility criteria

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.

Conditions

Coronary Artery Disease Erectile Dysfunction Atherosclerosis

Locations

Hospital Central Militar — Mexico City, Mexico City, Mexico

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record

Accelerate Your Clinical Trial Recruitment