Atherosclerosis Clinical Trials

Find Atherosclerosis Clinical Trials Near You

Characterization of Internal Pudendal Atherosclerosis by Intravascular Ultrasound and Near-Infrared Spectroscopy and Its Relationship With Erectile Dysfunction in Men With Coronary Artery Disease

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• Male participants aged 18 years or older.

• Documented or suspected coronary artery disease with a clinical indication for coronary angiography.

• Coronary IVUS-NIRS evaluation indicated by the treating interventional cardiologist.

• Sufficient clinical and hemodynamic stability to undergo the additional pudendal evaluation.

• Favorable pelvic vascular anatomy for selective angiography and safe advancement of the IVUS-NIRS catheter.

• Ability to complete the IIEF-5 questionnaire and provide information regarding sexual function.

• Written informed consent specifically for study participation and invasive evaluation of the internal pudendal arteries.

• Agreement to clinical follow-up by Cardiology and Urology.

Locations
Other Locations
Mexico
Hospital Central Militar
RECRUITING
Mexico City
Contact Information
Primary
José Raúl Méndez Colin, MD
dr.mendezcolin1989@gmail.com
+52 55 2516 3465
Backup
Luis Enrique Berumen Domínguez, MD
luisberumen@hotmail.com
+52 55 2122 1100
Time Frame
Start Date: 2026-09-24
Estimated Completion Date: 2027-12
Participants
Target number of participants: 60
Treatments
Experimental: Pudendal IVUS-NIRS Evaluation
Participants will undergo selective angiography of the internal iliac and internal pudendal arteries followed, when technically feasible and clinically safe, by investigational IVUS-NIRS imaging of one or both internal pudendal arteries.
Sponsors
Leads: Hospital Central Militar

This content was sourced from clinicaltrials.gov

Similar Clinical Trials