Trials / Recruiting
RecruitingNCT07444697
"Erectile Function After PCI in MI and Non-MI Patients"
Erectile Function After Percutaneous Coronary Intervention in Myocardial Infarction and Non-Infarction Patients: A Prospective Comparative Study.
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 100 (estimated)
- Sponsor
- Kırıkkale University · Academic / Other
- Sex
- Male
- Age
- 30 Years – 75 Years
- Healthy volunteers
- Accepted
Summary
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.
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.
Conditions
- Erectile Disfunction
- Coronary Artery Disease (CAD)
- Diabete Mellitus
- Anxiety
- Depression and Quality of Life
Timeline
- Start date
- 2026-01-15
- Primary completion
- 2026-11-01
- Completion
- 2026-11-01
- First posted
- 2026-03-03
- Last updated
- 2026-03-03
Locations
1 site across 1 country: Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT07444697. Inclusion in this directory is not an endorsement.