Postconditioning in ST-elevation Myocardial Infarction (POSTEMI)

September 26, 2016 updated by: Jan Eritsland, Oslo University Hospital

Postconditioning in ST-elevation Myocardial Infarction Treated With Primary PCI

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

272

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, N-0407
        • Dept. of Cardiology, Oslo Univ. Hosp. Ulleval

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.
Other: Control
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Infarct size, assessed by MRI
Time Frame: 4 months
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Myocardial blushing grade
Time Frame: assessed at the end of PCI procedure
assessed at the end of PCI procedure
ST-resolution in ECG
Time Frame: Assessed after 1 hour
Assessed after 1 hour
Troponin-T and CK-MB
Time Frame: peak release values
peak release values
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.
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
Time Frame: 1-year follow up.
1-year follow up.
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.
Baseline to 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Investigators

  • Study Chair: Jan Eritsland, MD, PhD, Oslo Univ.Hosp. Ulleval

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

June 16, 2009

First Submitted That Met QC Criteria

June 16, 2009

First Posted (Estimate)

June 17, 2009

Study Record Updates

Last Update Posted (Estimate)

September 27, 2016

Last Update Submitted That Met QC Criteria

September 26, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Po 1506

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Myocardial Infarction

Clinical Trials on Postconditioning

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Croatia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe