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临床试验/NCT03328156
NCT03328156Unknown不适用

Erectile Dysfunction After Percutaneous Coronary Intervention Versus the Thrombolytic Therapy in Acute ST Elevation Myocardial Infarction

Assiut University1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2017年10月30日最近更新:
适应症

试验速览

阶段
不适用
入组人数
300
试验地点
1
主要终点
The International Index of Erectile Function (IIEF-5) Questionnaire

研究概览

简要总结

Erectile dysfunction is a common sexual problem affecting up to one-third of men throughout their life. It is now well recognized that risk factors for erectile dysfunction (ED) include the same risk factors as coronary artery disease, including smoking, dyslipidemia, diabetes, hypertension, lack of physical activity and obesity. We will investigate the effect of reperfusion strategies (primary angioplasty & therapeutic therapy) on the prevalence of erectile dysfunction after acute myocardial infarction. Erectile function will be evaluated using the international index of erectile function after 3 months of successful reperfusion treatment of acute myocardial infarction.

详细描述

Myocardial infarction the term acute myocardial infarction(AMI) should be used when there is evidence of myocardial injury (defined as an elevation of cardiac troponin values with at least one value above the 99th percentile upper reference limit) with necrosis in a clinical setting consistent with myocardial ischemia . Myocardial infarction is classified as either : ST elevation acute myocardial infarction.* non-ST segment elevation acute myocardial infarction. according to the electrocardiogram at the time of admission.

There are Two main treatment modalities for STEMI which are primary percutaneous coronary intervention (PPCI) & thrombolytic treatment (TT).

  • Erectile dysfunction (ED) is defined as the recurrent or persistent inability to achieve and/or maintain an erection for satisfactory intercourse.Erectile function will be evaluated using the international index of erectile function in the hospital to characterize each patients sexual function before the acute myocardial infarction & 3 months after the event.

International Index of Erectile Function (IIEF-5) Questionnaire

  1. How do you rate your confidence that could you get and keep an erection? 1)very low 2)low 3)moderate 4)high 5)very high
  2. . When you had erections with sexual stimulation, how often were your erections hard enough for penetration?

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
Male
接受健康志愿者

入选标准

  • patients with ST elevation myocardial infarction undergo to of successful reperfusion treatment

排除标准

  • - patients with an atrial fibrillation or flutter.
  • -patients who cannot be reperfused with thrombolytic therapy and require emergency percutaneous coronary intervention (causing crossover between the groups).
  • congenital disease
  • pericardial disease
  • patients with renal failure
  • severe valvular heart disease
  • liver cirrhosis
  • thyroid disease
  • previous pelvic, penile, urethral or prostate surgery

结局指标

主要结局

The International Index of Erectile Function (IIEF-5) Questionnaire

时间窗: 3 months

the cases will be classified as: * without ED (score greater than 25 points) * mild ED (score 17 to 25), * moderate ED (score 11 to 16) * severe ED (score 10 points or less). No treatment for ED would applied within the 3-month period prior to the second IIEF evaluation for each patient

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohammed Mahmmoud Syed

Cardiology Resident

Assiut University

研究点 (1)

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