Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Patients who undergo PCI due to a heart attack | ||
| Group 2 | Patients who undergo PCI due to a stabile angina |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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] |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline (post-PCI recovery) and 6 months after PCI |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline (post-PCI recovery) and 6 months after PCI |
Inclusion Criteria
Male patients aged 30-75 years
Undergoing successful percutaneous coronary intervention (PCI) for one of the following:
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:
Known malignancy (active or recently treated)
Neurological disorders affecting erectile function, including:
Uncontrolled diabetes mellitus (HbA1c > 9%)
Presence of more than two chronic systemic diseases, such as:
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:
Major post-PCI complications preventing participation, including:
Male gender is suitable for the study due to evalute the penile erectile status
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Timucin Sipal, MD, PhD | Contact | +905338170659 | drtimucin@hotmail.com | |
| Caglar Alp, MD, PhD | Contact | +905054013070 | drcaglaralp@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hospital of Kirikkale Univerity Faculty of Medicine | Recruiting | Kirikkale | 71450 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28697641 | Result | 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. | |
| 30589239 | 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. |
Not provided
Not provided
Individual participant data will not be shared due to privacy considerations.
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Nov 7, 2025 | Jan 28, 2026 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D003920 | Diabetes Mellitus |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| D000787 | Angina Pectoris |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. | 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. | Baseline, 3 months, 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). | 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. | Baseline to 6 months follow-up |
| 33224004 | 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. |
| 39027197 | 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. |
| 15538397 | 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. |
| 16901623 | 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. |
| 18703470 | 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. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |