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Clinical Trials/NCT00922675
NCT00922675
Completed
Not Applicable

Postconditioning in ST-elevation Myocardial Infarction Treated With Primary PCI

Oslo University Hospital1 site in 1 country272 target enrollmentJune 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Myocardial Infarction
Sponsor
Oslo University Hospital
Enrollment
272
Locations
1
Primary Endpoint
Infarct size, assessed by MRI
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2009
End Date
August 2013
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Oslo University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Jan Eritsland

Senior Consultant Cardiology

Oslo University Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Infarct size, assessed by MRI

Time Frame: 4 months

Secondary Outcomes

  • 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)
  • 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)

Study Sites (1)

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