Clinical trial NCT03328156: Erectile Dysfunction After Percutaneous Coronary Intervention Versus the Thrombolytic Therapy in Acute ST Elevation Myocardial Infarction
Official title: Erectile Dysfunction After Percutaneous Coronary Intervention Versus the Thrombolytic Therapy in Acute ST Elevation Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: STEMI
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-11-01
Enrollment: 300
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: In this study; we aim to investigate the effects of two different reperfusion strategies (primary angioplasty \& therapeutic therapy) on the prevalence of erectile dysfunction after acute myocardial infarction.

Brief summary: 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.

Detailed description: 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?

1) Almost never/never 2) A few times (much less than half the time) 3) Sometimes (about half the time) 4) Most times (much more than half the time) 5) Almost always/always 3-During sexual intercourse, how often were you able to maintain your erection after you had penetrated (entered) your partner?

1. Almost never/never
2. A few times (much less than half the time)
3. Sometimes (about half the time)
4. Most times (much more than half the time)
5. Almost always/always 4- During sexual intercourse, how difficult was it to maintain your erection to completion of intercourse?

1) Extremely difficult 2) Very difficult 3) Difficult 4) Slightly difficult 5) Not difficult 5- When you attempted sexual intercourse, how often was it satisfactory for you?

1. ) Almost never/never
2. A few times (much less than half the time)
3. Sometimes (about half the time)
4. Most times (much more than half the time)
5. Almost always/always 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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* - 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

Primary outcomes:
measure: The International Index of Erectile Function (IIEF-5) Questionnaire
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University Hospital
Study officials:
affiliation: Assiut University
name: Yehia Taha Keshk, MD
role: STUDY_DIRECTOR
References:
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