"Erectile Function After PCI in MI and Non-MI Patients" (ERECT-PCI)

February 24, 2026 updated by: Timucin Sipal, Kırıkkale University

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

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
      • Kırıkkale, Turkey (Türkiye), 71450
        • Recruiting
        • The Hospital of Kirikkale Univerity Faculty of Medicine
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

Inclusion Criteria

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Group 1
Patients who undergo PCI due to a heart attack
Group 2
Patients who undergo PCI due to a stabile angina

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in erectile function score after percutaneous coronary intervention (PCI)
Time Frame: Baseline (post-recovery from PCI) to 6 months follow-up]

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of myocardial infarction on post-PCI erectile function
Time Frame: Baseline (post-PCI recovery) and 6 months after PCI
Erectile function will be assessed using the International Index of Erectile Function-5 (IIEF-5) questionnaire, and changes in IIEF-5 scores will be compared between patients with myocardial infarction and those with stable angina following percutaneous coronary intervention (PCI).
Baseline (post-PCI recovery) and 6 months after PCI
Effect of myocardial infarction on post-PCI erectile function
Time Frame: Baseline (post-PCI recovery) and 6 months after PCI
Erectile function will be assessed using the International Index of Erectile Function-5 (IIEF-5) questionnaire, and changes in IIEF-5 scores from baseline to 6 months after PCI will be compared between patients with myocardial infarction and those with stable angina.
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.
Time Frame: Baseline, 3 months, and 6 months after PCI
Fear symptoms will be assessed using the Fear of Cardiac Recurrence and Progression Scale (FCRP) scores, and their association with erectile function, as measured by the IIEF-5, will be examined.
Baseline, 3 months, and 6 months after PCI

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between SYNTAX score (angiographic coronary disease burden, points) and erectile function score measured by IIEF-5 (points)
Time Frame: Baseline (post-PCI recovery) and 6 months after PCI
Correlation between coronary artery disease burden quantified by the SYNTAX score (angiographic scoring system, unit: points) and erectile function measured using the International Index of Erectile Function-5 (IIEF-5; questionnaire score range 5-25 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)
Time Frame: Baseline, 3 months, and 6 months after PCI
Correlation between depressive symptom severity assessed using the Beck Depression Inventory (BDI; questionnaire score in points) and erectile function assessed by IIEF-5 (score 5-25 points).
Baseline, 3 months, and 6 months after PCI
Correlation between composite demographic-procedural risk score (points) and change in IIEF-5 score (points)
Time Frame: Baseline to 6 months follow-up
Correlation between a predefined composite risk score derived from baseline demographic and procedural variables (composite score expressed in points) and change in erectile function measured as the difference in IIEF-5 score (points) from baseline to 6 months.
Baseline to 6 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kırıkkale University

Investigators

  • Principal Investigator: Timucin Sipal, Assistan Prof, Kirikkale Univerity faculty of medicine department of Urology
  • Study Director: Caglar Alp, Assistant Prof, Kirikkale Univerity Faculty of Medicine department of Cardiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

January 20, 2026

First Submitted That Met QC Criteria

February 24, 2026

First Posted (Actual)

March 3, 2026

Study Record Updates

Last Update Posted (Actual)

March 3, 2026

Last Update Submitted That Met QC Criteria

February 24, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025.10.39

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared due to privacy considerations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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