Postconditioning in ST-elevation Myocardial Infarction (POSTEMI)
Study objectives: To assess the effects of postconditioning on infarct size in patients with ST-elevation infarction referred to PCI.
Study design: Prospective, randomized, open-label study with blinded endpoint evaluation. Included patients will be randomly allocated to postconditioning or control. Patients with symptoms of acute myocardial infarction of less than 6 hours duration fulfilling ECG criteria for primary PCI are eligible. PCI follow established routines. In postconditioning patients, additional, short (1 min), intermittent balloon occlusions will be applied after initial opening of infarct related artery. After this intervention, PCI proceeds routinely with stent implantation. In the control group, stent implantation after initial opening proceeds as usual. Primary endpoint is final infarct size, determined by MRI after 4 months. 260 patients will be included. Follow-up is 1 year. Inclusion period: 18 - 24 months.
Clinical implications: Reperfusion therapy, administered as early as possible after start of symptoms, has improved the prognosis in acute ST-elevation myocardial infarction. Still, however, many patients suffer large infarctions, subsequently with an increased risk of heart failure, arrhythmias, and death. In pilot studies, mechanical postconditioning has been shown to reduce infarct size and thus potentially improve prognosis. However, the effect of postconditioning must be confirmed in larger clinical trials before implemented in routine treatment.
Procedure: Control intervention
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Postconditioning in ST-elevation Myocardial Infarction Treated With Primary PCI|
- Infarct size, assessed by MRI [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
- Myocardial blushing grade [ Time Frame: assessed at the end of PCI procedure ] [ Designated as safety issue: No ]
- ST-resolution in ECG [ Time Frame: Assessed after 1 hour ] [ Designated as safety issue: No ]
- Troponin-T and CK-MB [ Time Frame: peak release values ] [ Designated as safety issue: No ]
- Echocardiographic evaluation of left ventricular function including speckle-tracking measurement. [ Time Frame: assessed at baseline, 4 months and1 year ] [ Designated as safety issue: No ]Assesment of LV function. Comparison with CMR in the whole study population and between treatment groups.
- Incidence of treated arrhythmias and heart failure during initial hospitalization Incidence of death, non-fatal myocardial infarction, unstable angina, heart failure, and cerebrovascular disease [ Time Frame: 1-year follow up. ] [ Designated as safety issue: Yes ]
- Myocardial salvage [ Time Frame: Baseline to 4 months ] [ Designated as safety issue: No ]Myocardial salvage defined as (area at risk-final infarct size)/area at risk. Area at risk measured by CMR at baseline and final infarct size by CMR at 4 months.
|Study Start Date:||June 2009|
|Study Completion Date:||August 2013|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
Active arm:Postconditioning protocol before routine PCI/stenting of an occluded coronary artery
After opening of IRA and establishment of TIMI-flow grade 2 or 3, the control group continues the procedure with stenting. In the postconditioning group 4 additional balloon inflations separated by 1 minute reperfusion are given, starting after 1 minute of reperfusion.
Control arm: Routine PCI/stenting of an occluded coronary artery without postconditioning
Procedure: Control intervention
After opening of IRA and establishment of TIMI-flow grade 2 or 3, the control group continues the procedure with stenting.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00922675
|Dept. of Cardiology, Oslo Univ. Hosp. Ulleval|
|Oslo, Norway, N-0407|
|Study Chair:||Jan Eritsland, MD, PhD||Oslo Univ.Hosp. Ulleval|