An observational study in Erectile Disfunction, Coronary Artery Disease (CAD) and Diabete Mellitus, sponsored by Kırıkkale University. Recruiting at 1 site in Turkey (Türkiye). Open to male participants aged 30 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-03.
Sponsored by Kırıkkale University · Observational
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.
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.
4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.
This study's planned enrollment of 100 is below the median of 320 across 1,687 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Kırıkkale University is the lead sponsor of 114 studies on the registry; 24 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Inclusion Criteria
Undergoing successful percutaneous coronary intervention (PCI) for one of the following:
Willingness and ability to complete follow-up visits and questionnaires at:
Neurological disorders affecting erectile function, including:
Presence of more than two chronic systemic diseases, such as:
Endocrine disorders, including:
Major post-PCI complications preventing participation, including:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients who undergo PCI due to a heart attack
Patients who undergo PCI due to a stabile angina
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.
Time frame: Baseline (post-recovery from PCI) to 6 months follow-up]
Effect of myocardial infarction on post-PCI erectile function
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).
Time frame: Baseline (post-PCI recovery) and 6 months after PCI
Effect of myocardial infarction on post-PCI erectile function
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.
Time frame: 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.
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.
Time frame: Baseline, 3 months, and 6 months after PCI
Correlation between SYNTAX score (angiographic coronary disease burden, points) and erectile function score measured by IIEF-5 (points)
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).
Time frame: 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)
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).
Time frame: Baseline, 3 months, and 6 months after PCI
Correlation between composite demographic-procedural risk score (points) and change in IIEF-5 score (points)
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.
Time frame: Baseline to 6 months follow-up
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Individual participant data will not be shared due to privacy considerations.
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