[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658715":3},{"organization":4,"outcomesModule":7,"designInfo":43,"detailedDescription":42,"studyPopulation":42,"armGroups":49,"interventions":57,"overallOfficials":68,"centralContacts":75,"locations":84,"responsibleParty":127,"collaborators":42,"id":129,"slug":130,"hasResults":131,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":135,"eligibilityCriteria":136,"healthyVolunteers":131,"sex":137,"minAge":138,"maxAge":42,"enrollmentInfo":139,"targetDuration":42,"studyType":142,"phases":143,"briefSummary":144,"conditions":145,"keywords":149,"overallStatus":86,"whyStopped":42,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":166},{"fullName":5,"class":6},"Hospital Central Militar","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":42},[9],{"measure":10,"description":11,"timeFrame":12},"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.","At the pudendal IVUS-NIRS procedure and within 30 days after enrollment for IIEF-5 assessment",[14,18,22,26,30,34,38],{"measure":15,"description":16,"timeFrame":17},"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.","During the pudendal IVUS-NIRS procedure",{"measure":19,"description":20,"timeFrame":21},"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.","During the index pudendal IVUS-NIRS procedure",{"measure":23,"description":24,"timeFrame":25},"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.","During the index coronary and pudendal IVUS-NIRS procedures",{"measure":27,"description":28,"timeFrame":29},"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.","Within 30 days after enrollment",{"measure":31,"description":32,"timeFrame":33},"Spearman Correlation Between Pudendal maxLCBI4mm and LDL Cholesterol","Spearman's rank correlation coefficient (rho) will be calculated between pudendal maxLCBI4mm measured by near-infrared spectroscopy (NIRS) and serum low-density lipoprotein cholesterol (LDL-C). Pudendal maxLCBI4mm is expressed as an index from 0 to 1000, with higher values indicating greater lipid burden. LDL-C is expressed in mg\u002FdL.","At baseline",{"measure":35,"description":36,"timeFrame":37},"Number of Participants With Successful Pudendal IVUS-NIRS Image Acquisition","The number of participants in whom analyzable IVUS-NIRS images are successfully obtained from at least one internal pudendal artery will be reported. Successful image acquisition is defined as acquisition of images of sufficient quality for quantitative IVUS and NIRS analysis.","Periprocedural",{"measure":39,"description":40,"timeFrame":41},"Procedure-Related Adverse Events","Adverse events related to selective pudendal angiography and IVUS-NIRS imaging will be recorded, including arterial dissection, perforation, persistent vasospasm, thrombosis, bleeding, contrast-associated kidney injury, embolization, or other complications considered attributable to the investigational pudendal procedure.","From the pudendal procedure through the 30-day study evaluation",null,{"allocation":44,"interventionModel":45,"interventionModelDescription":42,"primaryPurpose":46,"observationalModel":42,"timePerspective":42,"maskingInfo":47},"NA","SINGLE_GROUP","DIAGNOSTIC",{"masking":48,"maskingDescription":42,"whoMasked":42},"NONE",[50],{"label":51,"type":52,"description":53,"interventionNames":54},"Pudendal IVUS-NIRS Evaluation","EXPERIMENTAL","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.",[55,56],"Procedure: Selective Pudendal Angiography","Device: Pudendal IVUS-NIRS Imaging",[58,63],{"type":59,"name":60,"description":61,"armGroupLabels":62,"otherNames":42},"PROCEDURE","Selective Pudendal Angiography","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.",[51],{"type":64,"name":65,"description":66,"armGroupLabels":67,"otherNames":42},"DEVICE","Pudendal IVUS-NIRS Imaging","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.",[51],[69,72],{"name":70,"affiliation":5,"role":71},"José Raúl Méndez Colin, MD","PRINCIPAL_INVESTIGATOR",{"name":73,"affiliation":5,"role":74},"Luis Enrique Berumen Domínguez, MD","STUDY_DIRECTOR",[76,80],{"name":70,"role":77,"phone":78,"phoneExt":42,"email":79},"CONTACT","+52 55 2516 3465","dr.mendezcolin1989@gmail.com",{"name":73,"role":77,"phone":81,"phoneExt":82,"email":83},"+52 55 2122 1100","5028","luisberumen@hotmail.com",[85],{"facility":5,"status":86,"city":87,"state":87,"zip":88,"country":89,"countryCode":90,"cosmosGeoPoint":91,"geoPoint":96,"contacts":97},"RECRUITING","Mexico City","11200","Mexico","MX",{"type":92,"coordinates":93},"Point",[94,95],-99.12766,19.42847,{"lat":95,"lon":94},[98,99,100,101,103,105,107,109,111,113,115,117,119,121,123,125],{"name":70,"role":77,"phone":78,"phoneExt":42,"email":79},{"name":73,"role":77,"phone":42,"phoneExt":42,"email":83},{"name":70,"role":71,"phone":42,"phoneExt":42,"email":42},{"name":73,"role":102,"phone":42,"phoneExt":42,"email":42},"SUB_INVESTIGATOR",{"name":104,"role":102,"phone":42,"phoneExt":42,"email":42},"José Gadú Campos Salcedo, MD",{"name":106,"role":102,"phone":42,"phoneExt":42,"email":42},"Edwin García Sánchez, MD",{"name":108,"role":102,"phone":42,"phoneExt":42,"email":42},"Luis David Sánchez Mayo, MD",{"name":110,"role":102,"phone":42,"phoneExt":42,"email":42},"Aldo Figueroa Peña, MD",{"name":112,"role":102,"phone":42,"phoneExt":42,"email":42},"María Ximena Romo Cordero, MD",{"name":114,"role":102,"phone":42,"phoneExt":42,"email":42},"Roberto Paniagua Jiménez, MD",{"name":116,"role":102,"phone":42,"phoneExt":42,"email":42},"Eduardo Sánchez Cortés, MD",{"name":118,"role":102,"phone":42,"phoneExt":42,"email":42},"Ángel Leovigildo Alberto Delgado, MD",{"name":120,"role":102,"phone":42,"phoneExt":42,"email":42},"Alfredo Andrei Tort Hidalgo, MD",{"name":122,"role":102,"phone":42,"phoneExt":42,"email":42},"Cesar Gerardo Galván Vargas, MD",{"name":124,"role":102,"phone":42,"phoneExt":42,"email":42},"Mario Humberto Lozano Quintas, MD",{"name":126,"role":102,"phone":42,"phoneExt":42,"email":42},"Jorge Alberto Silva Rendón, MD",{"type":128,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR","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":140,"type":141},60,"ESTIMATED","INTERVENTIONAL",[44],"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.",[146,147,148],"Coronary Artery Disease","Erectile Dysfunction","Atherosclerosis",[150,151,152,153,154,155,156],"Internal Pudendal Artery","Intravascular Ultrasound","Near-Infrared Spectroscopy","IVUS-NIRS","Lipid Core Burden Index","maxLCBI4mm","IIEF-5","2026-09-30",{"date":159,"type":160},"2026-10-02","ACTUAL",{"date":162,"type":160},"2026-09-24",{"date":164,"type":141},"2027-12",{"name":5,"class":6},1]