Ischemic Postconditioning on Microvascular Obstruction in Reperfused Myocardial Infarction (POSTRE)
Objectives. We will evaluate the effect of ischemic postconditioning (PCON) on microvascular obstruction (MVO) in patients with a first ST-segment elevation myocardial infarction (STEMI) treated with primary angioplasty.
Background. PCON appears as a potentially beneficial tool in STEMI. Its impact on MVO is unknown.
Methods. In a multicenter study, 132 patients with a first STEMI will be randomized to undergo primary angioplasty followed by PCON or primary angioplasty alone (non-PCON). MVO and infarct size (IS) will be quantified (% of left ventricular mass) in a core laboratory analyzing late enhancement cardiovascular magnetic resonance imaging.
|Myocardial Infarction||Procedure: Primary angioplasty Procedure: Postconditioning|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
|Official Title:||Effect of Ischemic Postconditioning on Microvascular Obstruction in Reperfused Myocardial Infarction. Results of a Randomized Study in Patients|
- Microvascular obstruction [ Time Frame: 1 week ]Microvascular obstruction will be visually defined as a lack of contrast uptake in the core of tissue showing late gadolinium enhancement; the extent of microvascular obstruction will be manually defined and expressed as percentage of LV mass
- Infarct size [ Time Frame: 1 week ]Infarct size will be derived from late gadolinium enhancement and will be considered to be present if signal intensity is >2 standard deviations with respect to a sample of remote non-infarcted myocardium in late gadolinium enhancement imaging
|Study Start Date:||October 2011|
|Study Completion Date:||July 2012|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
Experimental: Primary angioplasty and postconditioning
Primary angioplasty followed by postconditioning
Procedure: Primary angioplasty
Primary angioplasty preceded by 300 mg aspirin plus 600 mg clopidogrel oral load doses. The radial approach and the use of thrombus aspiration catheters will be recommended. Stent will be implanted in all cases. Balloon pre-dilatation or direct stenting will be decided according to lesion characteristics.Procedure: Postconditioning
1 min after stent deployment, the angioplasty balloon will be re-inflated 4 times during 1 min at low-pressure (4 to 6 atmospheres), each separated by 1 min of reflow.
Active Comparator: Primary angioplasty
Primary angioplasty alone
Procedure: Primary angioplasty
Primary angioplasty preceded by 300 mg aspirin plus 600 mg clopidogrel oral load doses. The radial approach and the use of thrombus aspiration catheters will be recommended. Stent will be implanted in all cases. Balloon pre-dilatation or direct stenting will be decided according to lesion characteristics.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01898546
|Cardiology Department. Hospital Clinico Universitario-INCLIVA. University of Valencia.|
|Valencia, Spain, 46010|
|Principal Investigator:||Vicente Bodí||Cardiology Department. Hospital Clinico Universitario-INCLIVA|