Pudendal Atherosclerosis by IVUS-NIRS in Men With Coronary Artery Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorHospital Central Militar
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Cardiogenic shock, hemodynamic instability, or acute clinical deterioration.
Urgent or complicated coronary procedure in which prolonging the procedure would increase risk.
Advanced kidney disease or high risk of kidney injury associated with additional contrast administration.
Unfavorable iliofemoral or pelvic vascular anatomy for safe evaluation of the internal pudendal arteries.
Trial design
Design model
Single group
Treatments tested in this trial
Selective Pudendal Angiography
Procedure/SurgerySelective 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
DeviceWhen 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.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Pudendal IVUS-NIRS EvaluationExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Correlation Between Pudendal maxLCBI4mm and IIEF-5 Score
The association between the maximum lipid core burden index within a 4-mm segment (maxLCBI4mm) of the internal pudendal arteries, measured by IVUS-NIRS, and erectile function assessed by the 5-item International Index of Erectile Function (IIEF-5) will be evaluated using Spearman correlation. Pudendal maxLCBI4mm ranges from 0 to 1000, with higher values indicating greater lipid burden. IIEF-5 scores range from 5 to 25, with lower scores indicating more severe erectile dysfunction.
Time frame
At the pudendal IVUS-NIRS procedure and within 30 days after enrollment for IIEF-5 assessmentSecondary outcomes
1
Pudendal Artery Plaque Burden by IVUS
Pudendal artery plaque burden will be quantified by intravascular ultrasound (IVUS) as the proportion of the vessel area occupied by plaque plus media. Measurements will include plaque burden, minimum lumen area, and angiographic percent stenosis in the evaluated internal pudendal arteries.
Time frame
During the pudendal IVUS-NIRS procedure2
Pudendal Artery Lipid Burden by NIRS
Lipid burden in the internal pudendal arteries will be characterized using near-infrared spectroscopy (NIRS), including the Lipid Core Burden Index (LCBI) and maximum LCBI within any continuous 4-mm segment (maxLCBI4mm). If both internal pudendal arteries are evaluated, measurements from each side will be recorded and the highest maxLCBI4mm per participant will be used for the main analyses.
Time frame
During the index pudendal IVUS-NIRS procedure3
Correlation Between Pudendal and Coronary maxLCBI4mm
The association between pudendal and coronary lipid burden will be assessed by correlating the highest pudendal maxLCBI4mm with the highest coronary maxLCBI4mm obtained by IVUS-NIRS. The correlation will be evaluated using Spearman correlation.
Time frame
During the index coronary and pudendal IVUS-NIRS procedures4
Pudendal Atherosclerotic and Lipid Burden According to Erectile Dysfunction Severity
Pudendal atherosclerotic and lipid burden, including plaque burden and maxLCBI4mm, will be compared across erectile dysfunction severity categories defined by the IIEF-5 score: no erectile dysfunction, mild, mild-to-moderate, moderate, and severe erectile dysfunction.
Time frame
Within 30 days after enrollmentSponsors and contacts
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Source ClinicalTrials.gov