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

NCT07444697 | Recruiting DMC

• 1 other identifier: 2025.10.39
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Erectile Disfunction; Coronary Artery Disease (CAD); Diabete Mellitus; Anxiety; Depression and Quality of Life

Keywords

erectile disfunction; coronary artery disease; Syntax score; percutaneous coronary intervention; anxiety; Fear; angina

Outcome Measures

Primary Outcomes (1)

• Change in erectile function score after percutaneous coronary intervention (PCI)

  Description: Erectile function will be assessed using the International Index of Erectile Function-5 (IIEF-5) questionnaire. The primary outcome is the change in mean IIEF-5 score from baseline to 6 months after PCI, comparing patients with myocardial infarction (Group 1) and those with stable angina (Group 2). A decrease in IIEF-5 score indicates worsening erectile function.

  Baseline (post-recovery from PCI) to 6 months follow-up]

Secondary Outcomes (3)

• Effect of myocardial infarction on post-PCI erectile function

  Baseline (post-PCI recovery) and 6 months after PCI

• Effect of myocardial infarction on post-PCI erectile function

  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.

  Baseline, 3 months, and 6 months after PCI

Other Outcomes (3)

• Correlation between SYNTAX score (angiographic coronary disease burden, points) and erectile function score measured by IIEF-5 (points)

  Baseline (post-PCI recovery) and 6 months after PCI

• Correlation between Beck Depression Inventory (BDI) score (points) and erectile function score measured by IIEF-5 (points)

  Baseline, 3 months, and 6 months after PCI

• Correlation between composite demographic-procedural risk score (points) and change in IIEF-5 score (points)

  Baseline to 6 months follow-up

Study Arms (2)

Group 1

Patients who undergo PCI due to a heart attack

Group 2

Patients who undergo PCI due to a stabile angina

Eligibility Criteria

• Age: 30 Years - 75 Years
• Gender Eligibility Details: Male gender is suitable for the study due to evalute the penile erectile status
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population will consist of adult male patients treated with percutaneous coronary intervention (PCI) for either acute myocardial infarction or stable angina at the Cardiology Department of Kırıkkale University Hospital. Eligible participants will be recruited consecutively after successful PCI and clinical stabilization. The study represents a hospital-based, observational cohort reflecting the typical male population undergoing PCI in a tertiary referral center. All assessments and follow-up visits will be conducted within the same institution's cardiology and urology outpatient clinics.

You may qualify if:

• 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)
• months

You may not qualify if:

• 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:

Sponsors & Collaborators

• Kırıkkale University: lead

Study Sites (1)

The Hospital of Kirikkale Univerity Faculty of Medicine

Kırıkkale, 71450, Turkey (Türkiye)

RECRUITING

Related Publications (7)

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

MeSH Terms

Conditions

Coronary Artery Disease; Diabetes Mellitus; Anxiety Disorders; Depression; Angina Pectoris

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Mental Disorders; Behavioral Symptoms; Behavior; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Timucin Sipal, Assistan Prof

  Kirikkale Univerity faculty of medicine department of Urology

  PRINCIPAL INVESTIGATOR

• Caglar Alp, Assistant Prof

  Kirikkale Univerity Faculty of Medicine department of Cardiology

  STUDY DIRECTOR

Central Study Contacts

Timucin Sipal, MD, PhD

CONTACT

+905338170659; drtimucin@hotmail.com

Caglar Alp, MD, PhD

CONTACT

+905054013070; drcaglaralp@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistan profesor

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: March 3, 2026
• Study Start: January 15, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)