Postconditioning in ST-elevation Myocardial Infarction (POSTEMI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00922675
Recruitment Status : Completed
First Posted : June 17, 2009
Last Update Posted : September 27, 2016
Information provided by (Responsible Party):
Jan Eritsland, 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.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Procedure: Postconditioning Procedure: Control intervention Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 272 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Postconditioning in ST-elevation Myocardial Infarction Treated With Primary PCI
Study Start Date : June 2009
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Experimental: Postconditioning
Active arm:Postconditioning protocol before routine PCI/stenting of an occluded coronary artery
Procedure: Postconditioning
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.

Primary Outcome Measures :
  1. Infarct size, assessed by MRI [ Time Frame: 4 months ]

Secondary Outcome Measures :
  1. Myocardial blushing grade [ Time Frame: assessed at the end of PCI procedure ]
  2. ST-resolution in ECG [ Time Frame: Assessed after 1 hour ]
  3. Troponin-T and CK-MB [ Time Frame: peak release values ]
  4. Echocardiographic evaluation of left ventricular function including speckle-tracking measurement. [ Time Frame: assessed at baseline, 4 months and1 year ]
    Assesment of LV function. Comparison with CMR in the whole study population and between treatment groups.

  5. 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. ]
  6. Myocardial salvage [ Time Frame: 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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00922675

Dept. of Cardiology, Oslo Univ. Hosp. Ulleval
Oslo, Norway, N-0407
Sponsors and Collaborators
Oslo University Hospital
Study Chair: Jan Eritsland, MD, PhD Oslo Univ.Hosp. Ulleval

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Jan Eritsland, Senior Consultant Cardiology, Oslo University Hospital Identifier: NCT00922675     History of Changes
Other Study ID Numbers: Po 1506
First Posted: June 17, 2009    Key Record Dates
Last Update Posted: September 27, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jan Eritsland, Oslo University Hospital:
ST-elevation myocardial infarction

Additional relevant MeSH terms:
Myocardial Infarction
ST Elevation Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases