Postconditioning in ST-elevation Myocardial Infarction

Not Applicable

Completed

• Conditions: Myocardial Infarction
• Interventions: Procedure: Postconditioning; Procedure: Control intervention

• Registration Number: NCT00922675
• Lead Sponsor: Oslo University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-16
• Study First Submitted QC: 2009-06-16
• Study First Posted: 2009-06-17
• Primary Completion: 2012-08
• Study Completion: 2013-08
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-26
• Last Update Posted: 2016-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 272

Inclusion Criteria

• acute symptoms consistent with an acute myocardial infarction of less than 6 hours duration
• an occluded infarct related artery must be demonstrated (TIMI-flow 0-1)

Exclusion Criteria

• Prior myocardial infarction
• Demonstration of collaterals to the infarcted area
• TIMI-flow >1 before intervention or TIMI-flow <2 after initial balloon inflation
• Demonstration of a distal occlusion
• Patients given thrombolytic treatment
• Patients in cardiogenic shock
• Any contraindication to MRI (magnetic resonance imaging)
• Unwillingness to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Postconditioning	Postconditioning	Active arm:Postconditioning protocol before routine PCI/stenting of an occluded coronary artery
Control	Control intervention	Control arm: Routine PCI/stenting of an occluded coronary artery without postconditioning

Primary Outcome Measures

Name	Time	Method
Infarct size, assessed by MRI	4 months

Secondary Outcome Measures

Name	Time	Method
Myocardial blushing grade	assessed at the end of PCI procedure
Troponin-T and CK-MB	peak release values
ST-resolution in ECG	Assessed after 1 hour
Echocardiographic evaluation of left ventricular function including speckle-tracking measurement.	assessed at baseline, 4 months and1 year	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	1-year follow up.
Myocardial salvage	Baseline to 4 months	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.

Trial Locations

Locations (1)

Dept. of Cardiology, Oslo Univ. Hosp. Ulleval; 🇳🇴 Oslo, Norway