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Completed

NCT Number: NCT00922675

Postconditioning in ST-elevation Myocardial Infarction

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept. of Cardiology, Oslo Univ. Hosp. Ulleval

Oslo, N-0407, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Postconditioning

Procedure

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 intervention

Procedure

After opening of IRA and establishment of TIMI-flow grade 2 or 3, the control group continues the procedure with stenting.

Primary outcomes

  1. Infarct size, assessed by MRI

    Time frame: 4 months

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

Postconditioning in ST-elevation Myocardial Infarction Treated With Primary PCI

Acronym: POSTEMI

Important dates

Study start
2009
Primary completion
2012
Study completion
2013
First posted
Jun 17, 2009
Registry last updated
Sep 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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