"Erectile Function After PCI in MI and Non-MI Patients"
Recruiting · NCT07444697 · Observational (researchers observe without assigning treatment) · Lead sponsor: Kırıkkale University
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
30 Years to 75 Years
Sex
Male
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
1 location listed.
- The Hospital of Kirikkale Univerity Faculty of Medicine - Kirikkale, Turkey (Türkiye)