Ultrasound Beams as an Adjunct to Reperfusion Therapy in STEMI

November 21, 2014 updated by: Ramazan Akdemir, Sakarya University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

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

  • Turkey
      • Sakarya, Turkey, 54290
        • Recruiting
        • Sakarya University, Faculty of Medicine
        • Contact:

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Increase in left ventricular function
Time Frame: At 3 and 6 months
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
Time Frame: At 3 and 6 months
Ultrasound beams during echocardiography application expected to decrease infarct size
At 3 and 6 months

Collaborators and Investigators

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

Sponsor

Sakarya University

Investigators

  • Study Chair: Ramazan Akdemir, MD, Sakarya 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

January 1, 2013

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

February 1, 2016

Study Registration Dates

First Submitted

November 17, 2014

First Submitted That Met QC Criteria

November 21, 2014

First Posted (Estimate)

November 24, 2014

Study Record Updates

Last Update Posted (Estimate)

November 24, 2014

Last Update Submitted That Met QC Criteria

November 21, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCTSAU1400

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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