CClinicalTrials.gg
Status unknownNCT02299609Updated Nov 24, 2014

Ultrasound Beams as an Adjunct to Reperfusion Therapy in STEMI

An interventional study of Ultrasound beams Philips HD11 XE® in Myocardial Infarction and ST Elevation Myocardial Infarction, sponsored by Sakarya University. Status unknown at 1 site in Turkey. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-11-24.

Sponsored by Sakarya University · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Nov 2014), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Myocardial Infarction
  • ST Elevation Myocardial Infarction

Keywords

  • C14.280.647.500
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In context

Myocardial Infarction

2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.

This study's planned enrollment of 100 is below the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.

Browse Myocardial Infarction studies →

Lead sponsor

Sakarya University is the lead sponsor of 178 studies on the registry; 48 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
100 participants (estimated)

Study arms

  • Active comparator
    Beam Receiver

    Philips HD11 XE® 30 min qid x 4 days

    Other: Ultrasound beams Philips HD11 XE®

  • Sham comparator
    Beam Non-Receiver

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

    Other: Ultrasound beams Philips HD11 XE®

Interventions

  • OtherUltrasound beams Philips HD11 XE®

    Ultrasound beams used during standard echocardiography

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What researchers measure

Primary outcomes

  1. Increase in left ventricular function

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

    Time frame: At 3 and 6 months

Secondary outcomes

  1. Decrease in infarct size

    Ultrasound beams during echocardiography application expected to decrease infarct size

    Time frame: At 3 and 6 months

07

Study locations

1 of 1 sites recruiting
  • Sakarya University, Faculty of Medicine
    Sakarya, 54290, Turkey
    Recruiting
08

References and documents

Publications

  • 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. PubMed 23969167 ↗
  • 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. PubMed 24297498 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 24, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02299609
Lead sponsor
Sakarya University
Responsible party
Ramazan Akdemir (Prof. Ramazan Akdemir, MD, Sakarya University) — Principal investigator
First posted
Nov 24, 2014
Start date
Jan 2013
Primary completion
Dec 2015 (estimated)
Completion
Feb 2016 (estimated)
Last update
Nov 24, 2014

Study contacts

Ramazan Akdemir, MD
Contact
rakdemir@yahoo.com
00905336020700
Ramazan Akdemir, MD
Contact
ramazanakdemir@gmail.com
00905426427388
Ramazan Akdemir, MD
study chair · Sakarya University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.

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