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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age30-75
SponsorKırıkkale University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Male patients aged 30-75 years

Acute myocardial infarction (Group 1)

Stable angina (Group 2)

Hemodynamically stable after the PCI procedure

Disqualifiers

Known malignancy (active or recently treated)

Spinal cord injury

Multiple sclerosis

Parkinson's disease

Trial population

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.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

100 Participants
are grouped into 2 trial groups
Group A: Group 1
Group B: Group 2

Trial outcomes

Primary outcomes

1

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]

Secondary outcomes

1

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
2

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
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.

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

Other outcomes

1

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
2

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
3

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

Sponsors and contacts

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