Ultrasound Beams as an Adjunct to Reperfusion Therapy in STEMI
Therapeutic Effect of Ultrasound Beams as an Adjunct to Reperfusion Therapy in STEMI
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 17, 2014
CompletedFirst Posted
Study publicly available on registry
November 24, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedNovember 24, 2014
November 1, 2014
2.9 years
November 17, 2014
November 21, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Increase in left ventricular function
Ultrasound beams during echocardiography application expected to ameliorate the left ventricle function
At 3 and 6 months
Secondary Outcomes (1)
Decrease in infarct size
At 3 and 6 months
Study Arms (2)
Beam Receiver
ACTIVE COMPARATORPhilips HD11 XE® 30 min qid x 4 days
Beam Non-Receiver
SHAM COMPARATORPhilips HD11 XE® (ultrasound turned-off) 30 min qid x 4 days
Interventions
Ultrasound beams used during standard echocardiography
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients:
- With prior ST- elevation myocardial infarction
- Patients presenting \>12hrs
- Not successfully reperfused
- Not completed baseline ECHO evaluation,
- Not accepting participation in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sakarya University, Faculty of Medicine
Sakarya, 54290, Turkey (Türkiye)
Related 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. 2013 Nov;39(11):2001-10. doi: 10.1016/j.ultrasmedbio.2013.06.003. Epub 2013 Aug 19.
PMID: 23969167RESULTNazer 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.
PMID: 24297498RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ramazan Akdemir, MD
Sakarya University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Ramazan Akdemir, MD
Study Record Dates
First Submitted
November 17, 2014
First Posted
November 24, 2014
Study Start
January 1, 2013
Primary Completion
December 1, 2015
Study Completion
February 1, 2016
Last Updated
November 24, 2014
Record last verified: 2014-11