Ultrasound Beams as an Adjunct to Reperfusion Therapy in STEMI

Sakarya University

Status: Unknown

Conditions: ST Elevation Myocardial Infarction; Myocardial Infarction

Treatments: Other: Ultrasound beams Philips HD11 XE®

Study type: Interventional

Funder types: Other

Identifiers

NCT02299609

CCTSAU1400

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Beam Receiver

Active Comparator group

Description:

Philips HD11 XE® 30 min qid x 4 days

Treatment:

Other: Ultrasound beams Philips HD11 XE®

Beam Non-Receiver

Sham Comparator group

Description:

Philips HD11 XE® (ultrasound turned-off) 30 min qid x 4 days

Treatment:

Other: Ultrasound beams Philips HD11 XE®