Ultrasound Beams as an Adjunct to Reperfusion Therapy in STEMI

Study Overview
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Brief Summary
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Successfully perfused STEMI patients will receive routine transthoracic echocardiography qid for 4 days or placebo. Myocardial function and infarct size will be evaluated at 3 and 6 months.

Detailed Description
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Patients who had acute STEMI and successfully reperfused by either thrombolytic therapy or primary angioplasty and stenting will be included this study. A basal routine echocardiography will be obtained in all patients after reperfusion therapy. Thereafter, patients will be divided into two groups: 1.Treatment group will receive transthoracic echocardiography using Philips HD11 XE ® for 30 minutes qid for 4 days. 2. Placebo group will have the same Philips HD11 XE ® echo transducer applied for the same time and duration on their chest but with the ultrasound turned-off. Detailed left and right ventricle function as well as performance index and stress-strain imaging will be obtained and analyzed at 3 and 6 months.

Official Title
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Therapeutic Effect of Ultrasound Beams as an Adjunct to Reperfusion Therapy in STEMI

Conditions
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Myocardial Infarction, ST Elevation Myocardial Infarction

Intervention / Treatment
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* Other: Ultrasound beams Philips HD11 XE®


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: -Patients presenting within 12 hours of their first ST- elevation myocardial infarction that is successfully reperfused; and completed baseline echocardiographic evaluation and accepted participation in the study Exclusion criteria: Patients: With prior ST- elevation myocardial infarction Patients presenting >12hrs Not successfully reperfused Not completed baseline ECHO evaluation, Not accepting participation in the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Beam Receiver<br>Philips HD11 XE® 30 min qid x 4 days | Other: Ultrasound beams Philips HD11 XE®<br>* Ultrasound beams used during standard echocardiography<br>|
| Sham Comparator: Beam Non-Receiver<br>Philips HD11 XE® (ultrasound turned-off) 30 min qid x 4 days | Other: Ultrasound beams Philips HD11 XE®<br>* Ultrasound beams used during standard echocardiography<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase in left ventricular function | Ultrasound beams during echocardiography application expected to ameliorate the left ventricle function | At 3 and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in infarct size | Ultrasound beams during echocardiography application expected to decrease infarct size | At 3 and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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C14.280.647.500