"Erectile Function After PCI in MI and Non-MI Patients"

Официальное название

Erectile Function After Percutaneous Coronary Intervention in Myocardial Infarction and Non-Infarction Patients: A Prospective Comparative Study.

Обзор

The goal of this observational study is to assess changes in patients' erectile function after percutaneous coronary intervention (PCI) using a standard IIEF (International Index of Erectile Function) questionnaire at 1, 3, and 6 months post-PCI. By doing this, we try to compare patients' responses to PCI after having a heart attack and stable angina to see the real effect of myocardial infarction on erectile function status in the long term by comparing it with a very similar group.

Подробное описание

In Thıs study, we aım to evaluate the erectile status of male patients undergoing percutaneous coronary intervention after both heart attack ( group 1) and stable angina ( Group 2).

The primary aim is to assess any possible predictive effect of erectile function status on cardiac events.

The secondary aim is to assess the direct effect of myocardial infarction on ED status by comparing the two groups.

The secondary objective is to assess and analyse other determinants in the natural history survey of erectile status after the intervention.

All male patients who undergo a successful PCI and survive will be evaluated. Patients who have had: Malignancy, underlying neurological diagnosis interfering with erectile status, uncontrolled diabetes, and more than two chronic medical conditions, on polifarmacy ( more than three medications a day), and no sexual relationship, who have not agreed to include the study, will not be included in the study.

The follow-up period will be 0 (the time the patient recovered well after the intervention). Questinnaiere will examine the status over the last 3 months.

3 and 6-month follow-up. During the follow-up period, the interviews will be conducted face-to-face in the clinical environment, either by a responsible doctor or an educated nurse.

The surveys include:

IIEF (International Index of erectile function ) questionnaires BECK depression inventory questionnaires FCRP ( Fear of Cardiac Recurrence and Progression Scale )

The objective scale we use:

Age SYNTAX score and residual SYNTAX score for evaluating the cardiac vessels occlusion status Cardiac Ejection Fraction status Laboratory values, including testosterone levels, Bodily measurements, including body mass index and waist circumference. Medications Medical conditions Intervention route ( trans radial or femoral )

The survey will take place in our institutions.

The hypothesis is that erectile dysfunction is a preliminary condition of an upcoming cardiac event.

Myocardial infarction causes significant changes in erectile function in a natural survey.

The syntax score has a direct correlation with the baseline erectile function Residual syntax score has a direct relation with post-intervention erectile status.

Первичные конечные точки

• Change in erectile function score after percutaneous coronary intervention (PCI) [Срок оценки: Baseline (post-recovery from PCI) to 6 months follow-up]]

Вторичные конечные точки (3)

• Effect of myocardial infarction on post-PCI erectile function [Срок оценки: Baseline (post-PCI recovery) and 6 months after PCI]
• Effect of myocardial infarction on post-PCI erectile function [Срок оценки: Baseline (post-PCI recovery) and 6 months after PCI]
• Association between fear symptoms and post-PCI erectile function Fear symptoms will be assessed using the Beck Depression Inventory (BDI), and their association with erectile function measured by the IIEF-5 will be examined. [Срок оценки: Baseline, 3 months, and 6 months after PCI]

Критерии участия

Критерии включения

• Male patients aged 30-75 years
• Undergoing successful percutaneous coronary intervention (PCI) for one of the following:

• Acute myocardial infarction (Group 1)
• Stable angina (Group 2)
• Hemodynamically stable after the PCI procedure
• Survival of the index hospitalization
• Ability to provide written informed consent
• Sexually active within the 3 months prior to enrollment
• Willingness and ability to complete follow-up visits and questionnaires at:

• Baseline (post-PCI recovery)
• 3 months
• 6 months Exclusion Criteria
• Known malignancy (active or recently treated)
• Neurological disorders affecting erectile function, including:

• Spinal cord injury
• Multiple sclerosis
• Parkinson's disease
• Uncontrolled diabetes mellitus (HbA1c > 9%)
• Presence of more than two chronic systemic diseases, such as:

• Severe renal disease
• Severe hepatic disease
• Severe pulmonary disease
• Polypharmacy, defined as chronic use of more than three daily medications
• Absence of sexual activity or lack of a sexual partner
• Refusal or inability to provide informed consent or complete study questionnaires
• Severe psychiatric illness interfering with study participation
• Endocrine disorders, including:

• Untreated hypogonadism
• Thyroid disease
• Major post-PCI complications preventing participation, including:

• Reinfarction
• Stroke
• Heart failure

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Turkey (Türkiye) · 1 центр

• The Hospital of Kirikkale Univerity Faculty of Medicine — Kirikkale

Публикации

• Dostalova G, Hlubocka Z, Bayerova K, Belohlavek J, Linhart A, Karetova D. Erectile Dysfunction in Young Myocardial Infarction Survivors: Evaluation, Follow Up. Am J Mens Health. 2017 Nov;11(6):1739-1744. doi: 10.1177/1557988317714359. Epub 2017 Jul 11. PMID 28697641
• Hodzic E, Durek A, Begic E, Sabanovic Bajramovic N. Effect of myocardial infarction on the occurrence of erectile dysfunction. Med Glas (Zenica). 2019 Feb 1;16(1):35-39. doi: 10.17392/981-19. PMID 30589239
• Adam A, McDowall J, Aigbodion SJ, Enyuma C, Buchanan S, Vachiat A, Sheahan J, Laher AE. Is the History of Erectile Dysfunction a Reliable Risk Factor for New Onset Acute Myocardial Infarction? A Systematic Review and Meta-Analysis. Curr Urol. 2020 Oct;14(3):122-129. doi: 10.1159/000499249. Epub 2020 Oct 13. PMID 33224004
• Clarke ST, Le Grande M, Murphy BM, Hester R, Jackson AC. Protocol for the development and validation of a clinical measurement tool for fear of disease progression and recurrence in cardiac patients. Chronic Dis Transl Med. 2024 Jan 24;10(3):195-204. doi: 10.1002/cdt3.115. eCollection 2024 Sep. PMID 39027197
• Vacanti L, Caramelli B. Distress: associated variables of erectile dysfunction post-acute myocardial infarction. A pilot study. Int J Impot Res. 2005 Mar-Apr;17(2):204-6. doi: 10.1038/sj.ijir.3901274. PMID 15538397
• Montorsi P, Ravagnani PM, Galli S, Salonia A, Briganti A, Werba JP, Montorsi F. Association between erectile dysfunction and coronary artery disease: Matching the right target with the right test in the right patient. Eur Urol. 2006 Oct;50(4):721-31. doi: 10.1016/j.eururo.2006.07.015. Epub 2006 Jul 28. PMID 16901623
• Weintraub WS, Spertus JA, Kolm P, Maron DJ, Zhang Z, Jurkovitz C, Zhang W, Hartigan PM, Lewis C, Veledar E, Bowen J, Dunbar SB, Deaton C, Kaufman S, O'Rourke RA, Goeree R, Barnett PG, Teo KK, Boden WE; COURAGE Trial Research Group; Mancini GB. Effect of PCI on quality of life in patients with stable coronary disease. N Engl J Med. 2008 Aug 14;359(7):677-87. doi: 10.1056/NEJMoa072771. PMID 18703470

Идентификаторы

NCT: NCT07444697 · 2025.10.39

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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