[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Hospital Central Militar\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":50},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":5},"100658715","pudendal-atherosclerosis-by-ivus-nirs-in-men-with-coronary-artery-disease-100658715",false,"NCT07856199","Pudendal Atherosclerosis by IVUS-NIRS in Men With Coronary Artery Disease","Characterization of Internal Pudendal Atherosclerosis by Intravascular Ultrasound and Near-Infrared Spectroscopy and Its Relationship With Erectile Dysfunction in Men With Coronary Artery Disease","PUDENDAL-NIRS","Inclusion Criteria:\n\n1. Male participants aged 18 years or older.\n2. Documented or suspected coronary artery disease with a clinical indication for coronary angiography.\n3. Coronary IVUS-NIRS evaluation indicated by the treating interventional cardiologist.\n4. Sufficient clinical and hemodynamic stability to undergo the additional pudendal evaluation.\n5. Favorable pelvic vascular anatomy for selective angiography and safe advancement of the IVUS-NIRS catheter.\n6. Ability to complete the IIEF-5 questionnaire and provide information regarding sexual function.\n7. Written informed consent specifically for study participation and invasive evaluation of the internal pudendal arteries.\n8. Agreement to clinical follow-up by Cardiology and Urology.\n\nExclusion Criteria:\n\n1. Cardiogenic shock, hemodynamic instability, or acute clinical deterioration.\n2. Urgent or complicated coronary procedure in which prolonging the procedure would increase risk.\n3. Advanced kidney disease or high risk of kidney injury associated with additional contrast administration.\n4. Unfavorable iliofemoral or pelvic vascular anatomy for safe evaluation of the internal pudendal arteries.\n5. Severe coagulopathy, active bleeding, or contraindication to the invasive procedure.\n6. History of radical pelvic surgery or pelvic radiotherapy.\n7. Advanced prostate cancer or previous urologic treatment that predominantly explains erectile dysfunction.\n8. Severe untreated hypogonadism, advanced neurologic disease, or another predominant nonvascular cause of erectile dysfunction.\n9. Inability to reliably complete the IIEF-5 questionnaire.\n10. Refusal to participate or to provide study-specific written informed consent.","MALE","18 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"NA","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.\n\nAfter 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).\n\nThe 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.",[27,28,29],"Coronary Artery Disease","Erectile Dysfunction","Atherosclerosis",[31,32,33,34,35,36,37],"Internal Pudendal Artery","Intravascular Ultrasound","Near-Infrared Spectroscopy","IVUS-NIRS","Lipid Core Burden Index","maxLCBI4mm","IIEF-5","RECRUITING","2026-09-30",{"date":41,"type":42},"2026-10-02","ACTUAL",{"date":44,"type":42},"2026-09-24",{"date":46,"type":21},"2027-12",{"name":48,"class":49},"Hospital Central Militar","OTHER_GOV",""]