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Ultrasound Beams as an Adjunct to Reperfusion Therapy in STEMI

Primary Purpose

Myocardial Infarction, ST Elevation Myocardial Infarction

Status

Unknown status

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Ultrasound beams Philips HD11 XE®

About this trial

This is an interventional supportive care trial for Myocardial Infarction focused on measuring C14.280.647.500

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Sakarya University, Faculty of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Beam Receiver

Beam Non-Receiver

Arm Description

Philips HD11 XE® 30 min qid x 4 days

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

Outcomes

Primary Outcome Measures

Increase in left ventricular function

Ultrasound beams during echocardiography application expected to ameliorate the left ventricle function

Secondary Outcome Measures

Decrease in infarct size

Ultrasound beams during echocardiography application expected to decrease infarct size

Full Information

NCT ID

NCT02299609

First Posted

November 17, 2014

Last Updated

November 21, 2014

Sponsor

Sakarya University

1. Study Identification

Unique Protocol Identification Number

NCT02299609

Brief Title

Ultrasound Beams as an Adjunct to Reperfusion Therapy in STEMI

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Unknown status

Study Start Date

January 2013 (undefined)

Primary Completion Date

December 2015 (Anticipated)

Study Completion Date

February 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sakarya University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myocardial Infarction, ST Elevation Myocardial Infarction

Keywords

C14.280.647.500

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Beam Receiver

Arm Type

Active Comparator

Arm Description

Philips HD11 XE® 30 min qid x 4 days

Arm Title

Beam Non-Receiver

Arm Type

Sham Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Ultrasound beams Philips HD11 XE®

Intervention Description

Ultrasound beams used during standard echocardiography

Primary Outcome Measure Information:

Title

Increase in left ventricular function

Description

Ultrasound beams during echocardiography application expected to ameliorate the left ventricle function

Time Frame

At 3 and 6 months

Secondary Outcome Measure Information:

Title

Decrease in infarct size

Description

Ultrasound beams during echocardiography application expected to decrease infarct size

Time Frame

At 3 and 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ramazan Akdemir, MD

Phone

00905336020700

rakdemir@yahoo.com

First Name & Middle Initial & Last Name or Official Title & Degree

Ramazan Akdemir, MD

Phone

00905426427388

ramazanakdemir@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ramazan Akdemir, MD

Organizational Affiliation

Sakarya University

Official's Role

Study Chair

Facility Information:

Facility Name

Sakarya University, Faculty of Medicine

City

Sakarya

ZIP/Postal Code

54290

Country

Turkey

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ramazan Akdemir, MD

Phone

00905336020700

rakdemir@yahoo.com

12. IPD Sharing Statement

Citations:

PubMed Identifier

23969167

Citation

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. 2013 Nov;39(11):2001-10. doi: 10.1016/j.ultrasmedbio.2013.06.003. Epub 2013 Aug 19.

Results Reference

result

PubMed Identifier

24297498

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.

Results Reference

result

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Ultrasound Beams as an Adjunct to Reperfusion Therapy in STEMI

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