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

November 3, 2017 updated by: Mohammed Mahmmoud Syed, Assiut University

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.

Study Overview

Status

Unknown

Conditions

STEMI

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

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
. 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?

Almost never/never
A few times (much less than half the time)
Sometimes (about half the time)
Most times (much more than half the time)
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?

) Almost never/never
A few times (much less than half the time)
Sometimes (about half the time)
Most times (much more than half the time)
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

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Egypt
- - Assiut, Egypt
    - Assiut University hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

ADULT
OLDER_ADULT
CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
patient with STEMI will treated by PPCI Primary angioplasty procedure The procedure will be performed using a standard angioplasty technique. A bolus of100 IU kg of heparin will be administered intra-arterially after insertion of the vascular catheter. The target lesions will initially treated with appropriate balloon predilatation as necessary, followed by intracoronary stenting. After stent implantation, heparin will be routinely administered. The sheaths will be removed the same day.
patient with STEMI will treated by Thrombolytic therapy oral clopidogrel (300 mg), Low-flow nasal oxygen, oral acetylsalicylic acid (325 mg), Will be given to each patient. Streptokinase will be given intravenously at 1.5 million units over approximately 60 min. Reperfusion afterTT will be assessed according to clinical criteria .

Group / Cohort

patient with STEMI will treated by PPCI

Primary angioplasty procedure The procedure will be performed using a standard angioplasty technique. A bolus of100 IU kg of heparin will be administered intra-arterially after insertion of the vascular catheter. The target lesions will initially treated with appropriate balloon predilatation as necessary, followed by intracoronary stenting. After stent implantation, heparin will be routinely administered. The sheaths will be removed the same day.

patient with STEMI will treated by Thrombolytic therapy

oral clopidogrel (300 mg), Low-flow nasal oxygen, oral acetylsalicylic acid (325 mg), Will be given to each patient. Streptokinase will be given intravenously at 1.5 million units over approximately 60 min. Reperfusion afterTT will be assessed according to clinical criteria .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The International Index of Erectile Function (IIEF-5) Questionnaire Time Frame: 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	3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

Study Director: Yehia Taha Keshk, MD, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 30, 2017

Primary Completion (ANTICIPATED)

October 1, 2018

Study Completion (ANTICIPATED)

November 1, 2018

Study Registration Dates

First Submitted

October 29, 2017

First Submitted That Met QC Criteria