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Pudendal Atherosclerosis by IVUS-NIRS in Men With Coronary Artery Disease
60 patients around the world
Available in
Mexico
Hospital Central Militar
1
Research sites
60
Patients around the world
This study is for people with
Coronary disease
Coronary Artery Disease
Requirements for the patient
From 18 Years
Male
Medical requirements
Inclusion criteria
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.
Exclusion criteria
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.
Severe coagulopathy, active bleeding, or contraindication to the invasive procedure.
History of radical pelvic surgery or pelvic radiotherapy.
Advanced prostate cancer or previous urologic treatment that predominantly explains erectile dysfunction.
Severe untreated hypogonadism, advanced neurologic disease, or another predominant nonvascular cause of erectile dysfunction.
Inability to reliably complete the IIEF-5 questionnaire.
Refusal to participate or to provide study-specific written informed consent.
Sites
Hospital Central Militar - Mexico
Recruiting
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Perif. Blvd. Manuel Ávila Camacho, Mexico
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Study
PUDENDAL-NIRS
Sponsor
Hospital Central Militar
Study type
Interventional
Conditions
Coronary Artery Disease
Requirements
From 18 Years
Male
Unique study ID
clinicaltrials.gov
NCT07856199
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