Pudendal Atherosclerosis by IVUS-NIRS in Men With Coronary Artery Disease (PUDENDAL-NIRS)
Characterization of Internal Pudendal Atherosclerosis by Intravascular Ultrasound and Near-Infrared Spectroscopy and Its Relationship With Erectile Dysfunction in Men With Coronary Artery Disease
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.
Panoramica dello studio
Stato
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: José Raúl Méndez Colin, MD
- Numero di telefono: +52 55 2516 3465
- Email: dr.mendezcolin1989@gmail.com
Backup dei contatti dello studio
- Nome: Luis Enrique Berumen Domínguez, MD
- Numero di telefono: 5028 +52 55 2122 1100
- Email: luisberumen@hotmail.com
Luoghi di studio
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Mexico City
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Mexico City, Mexico City, Messico, 11200
- Reclutamento
- Hospital Central Militar
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Contatto:
- José Raúl Méndez Colin, MD
- Numero di telefono: +52 55 2516 3465
- Email: dr.mendezcolin1989@gmail.com
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Contatto:
- Luis Enrique Berumen Domínguez, MD
- Email: luisberumen@hotmail.com
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Investigatore principale:
- José Raúl Méndez Colin, MD
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Sub-investigatore:
- Luis Enrique Berumen Domínguez, MD
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Sub-investigatore:
- José Gadú Campos Salcedo, MD
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Sub-investigatore:
- Edwin García Sánchez, MD
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Sub-investigatore:
- Luis David Sánchez Mayo, MD
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Sub-investigatore:
- Aldo Figueroa Peña, MD
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Sub-investigatore:
- María Ximena Romo Cordero, MD
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Sub-investigatore:
- Roberto Paniagua Jiménez, MD
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Sub-investigatore:
- Eduardo Sánchez Cortés, MD
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Sub-investigatore:
- Ángel Leovigildo Alberto Delgado, MD
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Sub-investigatore:
- Alfredo Andrei Tort Hidalgo, MD
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Sub-investigatore:
- Cesar Gerardo Galván Vargas, MD
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Sub-investigatore:
- Mario Humberto Lozano Quintas, MD
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Sub-investigatore:
- Jorge Alberto Silva Rendón, MD
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Diagnostico
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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. |
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. 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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Correlation Between Pudendal maxLCBI4mm and IIEF-5 Score
Lasso di tempo: At the pudendal IVUS-NIRS procedure and within 30 days after enrollment for IIEF-5 assessment
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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
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Pudendal Artery Plaque Burden by IVUS
Lasso di tempo: During the pudendal IVUS-NIRS procedure
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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
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Pudendal Artery Lipid Burden by NIRS
Lasso di tempo: During the index pudendal IVUS-NIRS procedure
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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
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Correlation Between Pudendal and Coronary maxLCBI4mm
Lasso di tempo: During the index coronary and pudendal IVUS-NIRS procedures
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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
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Pudendal Atherosclerotic and Lipid Burden According to Erectile Dysfunction Severity
Lasso di tempo: Within 30 days after enrollment
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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
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Spearman Correlation Between Pudendal maxLCBI4mm and LDL Cholesterol
Lasso di tempo: At baseline
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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/dL. |
At baseline
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Number of Participants With Successful Pudendal IVUS-NIRS Image Acquisition
Lasso di tempo: Periprocedural
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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
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Procedure-Related Adverse Events
Lasso di tempo: From the pudendal procedure through the 30-day study evaluation
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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
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: José Raúl Méndez Colin, MD, Hospital Central Militar
- Direttore dello studio: Luis Enrique Berumen Domínguez, MD, Hospital Central Militar
Pubblicazioni e link utili
Pubblicazioni generali
- Montorsi P, Ravagnani PM, Galli S, Rotatori F, Veglia F, Briganti A, Salonia A, Deho F, Rigatti P, Montorsi F, Fiorentini C. Association between erectile dysfunction and coronary artery disease. Role of coronary clinical presentation and extent of coronary vessels involvement: the COBRA trial. Eur Heart J. 2006 Nov;27(22):2632-9. doi: 10.1093/eurheartj/ehl142. Epub 2006 Jul 19.
- Erlinge D, Maehara A, Ben-Yehuda O, Botker HE, Maeng M, Kjoller-Hansen L, Engstrom T, Matsumura M, Crowley A, Dressler O, Mintz GS, Frobert O, Persson J, Wiseth R, Larsen AI, Okkels Jensen L, Nordrehaug JE, Bleie O, Omerovic E, Held C, James SK, Ali ZA, Muller JE, Stone GW; PROSPECT II Investigators. Identification of vulnerable plaques and patients by intracoronary near-infrared spectroscopy and ultrasound (PROSPECT II): a prospective natural history study. Lancet. 2021 Mar 13;397(10278):985-995. doi: 10.1016/S0140-6736(21)00249-X.
- Rosen RC, Cappelleri JC, Smith MD, Lipsky J, Pena BM. Development and evaluation of an abridged, 5-item version of the International Index of Erectile Function (IIEF-5) as a diagnostic tool for erectile dysfunction. Int J Impot Res. 1999 Dec;11(6):319-26. doi: 10.1038/sj.ijir.3900472.
- Waksman R, Di Mario C, Torguson R, Ali ZA, Singh V, Skinner WH, Artis AK, Cate TT, Powers E, Kim C, Regar E, Wong SC, Lewis S, Wykrzykowska J, Dube S, Kazziha S, van der Ent M, Shah P, Craig PE, Zou Q, Kolm P, Brewer HB, Garcia-Garcia HM; LRP Investigators. Identification of patients and plaques vulnerable to future coronary events with near-infrared spectroscopy intravascular ultrasound imaging: a prospective, cohort study. Lancet. 2019 Nov 2;394(10209):1629-1637. doi: 10.1016/S0140-6736(19)31794-5. Epub 2019 Sep 27.
- Zacharias SK, Safian RD, Madder RD, Hanson ID, Pica MC, Smith JL, Goldstein JA, Abbas AE. Invasive evaluation of plaque morphology of symptomatic superficial femoral artery stenoses using combined near-infrared spectroscopy and intravascular ultrasound. Vasc Med. 2016 Aug;21(4):337-44. doi: 10.1177/1358863X16631420. Epub 2016 Mar 8.
- Rogers JH, Karimi H, Kao J, Link D, Javidan J, Yamasaki DS, Dolan M, Laird JR, Low RI. Internal pudendal artery stenoses and erectile dysfunction: correlation with angiographic coronary artery disease. Catheter Cardiovasc Interv. 2010 Nov 15;76(6):882-7. doi: 10.1002/ccd.22646. Epub 2010 Oct 6.
- Park HW, Her SH, Park BH, Han DS, Yuk SM, Kim DW, Youn CS, Jang H. Correlation between internal pudendal artery stenosis and erectile dysfunction in patients with suspected coronary artery disease. PLoS One. 2019 Nov 12;14(11):e0225179. doi: 10.1371/journal.pone.0225179. eCollection 2019.
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Date di iscrizione allo studio
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Primo Inserito (Effettivo)
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Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie urogenitali
- Malattie genitali
- Malattie vascolari
- Malattia cardiovascolare
- Disordini mentali
- Malattie genitali, maschio
- Malattie urogenitali maschili
- Malattie cardiache
- Arteriosclerosi
- Malattie arteriose occlusive
- Malattia coronarica
- Ischemia miocardica
- Disfunzione sessuale, fisiologica
- Disfunzioni sessuali, psicologiche
- Disfunsione dell'arteria coronaria
- Disfunzione erettile
- Aterosclerosi
Altri numeri di identificazione dello studio
- HCM-PUDENDAL-NIRS-2026
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Individual participant data (IPD) will not be shared because the study protocol and informed consent do not include a plan for external sharing of participant-level data. Study data will remain under institutional custody and will be used for the approved research objectives, analyses, and scientific publications while maintaining participant confidentiality.
Informazioni su farmaci e dispositivi, documenti di studio
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Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
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