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NCT Number: NCT07444697

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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.

  3. 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.

Other outcomes

  1. 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).

  2. 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).

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Caglar Alp, MD, PhD

CONTACT

[email protected]

+905054013070

Timucin Sipal, MD, PhD

CONTACT

[email protected]

+905338170659

Sponsors and collaborators

Lead sponsor

Kırıkkale University

Other

Registry information

Official study title

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

Acronym: ERECT-PCI

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 3, 2026
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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