Ultrasound Beams as an Adjunct to Reperfusion Therapy in STEMI

Not Applicable

• Conditions: Myocardial Infarction; ST Elevation Myocardial Infarction
• Interventions: Other: Ultrasound beams Philips HD11 XE®

• Registration Number: NCT02299609
• Lead Sponsor: Sakarya University

Brief Summary

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

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.

Study Timeline

• Study Start: 2013-01
• Status Verified: 2014-11
• Study First Submitted: 2014-11-17
• Study First Submitted QC: 2014-11-21
• Last Update Submitted: 2014-11-21
• Study First Posted: 2014-11-24
• Last Update Posted: 2014-11-24
• Primary Completion: 2015-12
• Study Completion: 2016-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Beam Receiver	Ultrasound beams Philips HD11 XE®	Philips HD11 XE® 30 min qid x 4 days
Beam Non-Receiver	Ultrasound beams Philips HD11 XE®	Philips HD11 XE® (ultrasound turned-off) 30 min qid x 4 days

Primary Outcome Measures

Name	Time	Method
Increase in left ventricular function	At 3 and 6 months	Ultrasound beams during echocardiography application expected to ameliorate the left ventricle function

Secondary Outcome Measures

Name	Time	Method
Decrease in infarct size	At 3 and 6 months	Ultrasound beams during echocardiography application expected to decrease infarct size

Trial Locations

Locations (1)

Sakarya University, Faculty of Medicine; 🇹🇷 Sakarya, Turkey