Minimizing Reperfusion Injury in Patients With Acute Myocardial Infarction
NCT ID: NCT00846378
Last Updated: 2014-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
PHASE1
30 participants
INTERVENTIONAL
2008-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Post conditioning
After 30 seconds of re-established coronary flow following the therapeutic balloon dilatation and deflation, the same balloon will be re-inflated for 30 seconds and then again deflated for 30 seconds. The balloon should be inflated to only occlude the coronary artery. This procedure of balloon inflation/deflation will be performed a total of 3 to 4 times.
Post conditioning
after 30 seconds of re-established coronary flow following the therapeutic balloon dilatation and deflation, the same balloon will be re-inflated for 30 seconds and then again deflated for 30 seconds. This procedure of balloon inflation/deflation will be performed a total of 3 to 4 times.
Usual Care
Usual care for treatment of thrombolysis in myocardial infarction (TIMI) 0 to TIMI 1 flow in occluded infarct related artery. Usual care includes reperfusion of the artery per operator discretion, i.e. primary stenting, thrombectomy, balloon inflation/deflation without timed intervals.
Usual Care for STEMI
Usual care for treatment of TIMI 0 to TIMI 1 flow in occluded infarct related artery. Usual care includes reperfusion of the artery per operator discretion, i.e. primary stenting, thrombectomy, balloon inflation/deflation without timed intervals.
Interventions
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Post conditioning
after 30 seconds of re-established coronary flow following the therapeutic balloon dilatation and deflation, the same balloon will be re-inflated for 30 seconds and then again deflated for 30 seconds. This procedure of balloon inflation/deflation will be performed a total of 3 to 4 times.
Usual Care for STEMI
Usual care for treatment of TIMI 0 to TIMI 1 flow in occluded infarct related artery. Usual care includes reperfusion of the artery per operator discretion, i.e. primary stenting, thrombectomy, balloon inflation/deflation without timed intervals.
Eligibility Criteria
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Inclusion Criteria
* Onset of symptoms within 6 hours
* TIMI 0 to TIMI 1 flow in infarct related artery
Exclusion Criteria
* previous infarct in related territory
* thrombolytics
* cardiogenic shock
* TIMI 2 to TIMI 3 flow
18 Years
ALL
No
Sponsors
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Cardiology Research UBC
OTHER
University of Cincinnati
OTHER
Responsible Party
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Tarek Helmy
Professor
Principal Investigators
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Tarek Helmy, MD
Role: PRINCIPAL_INVESTIGATOR
University of Cincinnati
Locations
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University of Cincinnati
Cincinnati, Ohio, United States
Countries
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Other Identifiers
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UCIRB07051803
Identifier Type: -
Identifier Source: org_study_id
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