Erectile Function After Percutaneous Coronary Intervention in Myocardial Infarction and Non-Infarction Patients: A Prospective Comparative Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in erectile function score after percutaneous coronary intervention (PCI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
- •Heart failure
研究组 & 干预措施
Group 1
Patients who undergo PCI due to a heart attack
Group 2
Patients who undergo PCI due to a stabile angina
结局指标
主要结局
Change in erectile function score after percutaneous coronary intervention (PCI)
时间窗: 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.
次要结局
- Effect of myocardial infarction on post-PCI erectile function(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.(Baseline, 3 months, and 6 months after PCI)
研究者
Timucin Sipal
Assistan profesor
Kırıkkale University