Anxiety, Coronary Artery Disease (CAD), Depression and Quality of Life, Diabete Mellitus, Erectile Disfunction
Conditions
Keywords
erectile disfunction, coronary artery disease, Syntax score, percutaneous coronary intervention, anxiety, Fear, angina
Brief 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.
Interventions
None listed
Sponsors
Kırıkkale University
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
30 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in erectile function score after percutaneous coronary intervention (PCI) | Baseline (post-recovery from PCI) to 6 months follow-up] | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of myocardial infarction on post-PCI erectile function | Baseline (post-PCI recovery) and 6 months after PCI | 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). |
| 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. | Baseline, 3 months, and 6 months after PCI | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTTimucin Sipal, MD, PhD
CONTACTCaglar Alp, MD, PhD
PRINCIPAL_INVESTIGATORTimucin Sipal, Assistan Prof
Kirikkale Univerity faculty of medicine department of Urology
STUDY_DIRECTORCaglar Alp, Assistant Prof
Kirikkale Univerity Faculty of Medicine department of Cardiology
Outcome results
None listed