Ultrasound Beams as an Adjunct to Reperfusion Therapy in STEMI

Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02299609
• Other study ID #: CCTSAU1400
• Status: Recruiting
• Phase: N/A
• First received: November 17, 2014
• Last updated: November 21, 2014
• Start date: January 2013
• Est. completion date: February 2016

Study information

• Verified date: November 2014
• Source: Sakarya University
• Contact: Ramazan Akdemir, MD
• Phone: 00905336020700
• Email: rakdemir[@]yahoo.com
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction

Intervention

Other:
• Ultrasound beams Philips HD11 XE®
Ultrasound beams used during standard echocardiography

Locations

Country	Name	City	State
Turkey	Sakarya University, Faculty of Medicine	Sakarya

Sponsors (1)

Lead Sponsor	Collaborator
Sakarya University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Ling ZY, Shu SY, Zhong SG, Luo J, Su L, Liu ZZ, Lan XB, Yuan GB, Zheng YY, Ran HT, Wang ZG, Yin YH. Ultrasound targeted microbubble destruction promotes angiogenesis and heart function by inducing myocardial microenvironment change. Ultrasound Med Biol. 2 — View Citation

Nazer B, Gerstenfeld EP, Hata A, Crum LA, Matula TJ. Cardiovascular applications of therapeutic ultrasound. J Interv Card Electrophysiol. 2014 Apr;39(3):287-94. doi: 10.1007/s10840-013-9845-z. Epub 2013 Dec 3. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase in left ventricular function	Ultrasound beams during echocardiography application expected to ameliorate the left ventricle function	At 3 and 6 months	No
Secondary	Decrease in infarct size	Ultrasound beams during echocardiography application expected to decrease infarct size	At 3 and 6 months	No