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

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

Recruiting
30-75 years
Male
Phase N/A

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Overview

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.

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.

Eligibility

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

NCT07444697

Kırıkkale University

13 May 2026

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