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Postconditioning in ST-elevation Myocardial Infarction (POSTEMI)

This study is currently recruiting participants.
Verified June 2012 by Oslo University Hospital
Sponsor:
Information provided by (Responsible Party):
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00922675
First received: June 16, 2009
Last updated: June 19, 2012
Last verified: June 2012
History of Changes
  Purpose

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 Intervention
Myocardial Infarction
 Procedure: Postconditioning
Procedure: Control intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Postconditioning in ST-elevation Myocardial Infarction Treated With Primary PCI

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Infarct size, assessed by MRI [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Myocardial blushing grade [ Time Frame: assessed at the end of PCI procedure ] [ Designated as safety issue: No ]
  • ST-resolution in ECG [ Time Frame: Assessed after 1 hour ] [ Designated as safety issue: No ]
  • Troponin-T and CK-MB [ Time Frame: peak release values ] [ Designated as safety issue: No ]
  • Echocardiographic evaluation of left ventricular function including speckle-tracking measurement. [ Time Frame: assessed at baseline, 4 months and1 year ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1-year follow up. ] [ Designated as safety issue: Yes ]
  • Myocardial salvage [ Time Frame: Baseline to 4 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 260
Study Start Date: June 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00922675

Contacts
Contact: Jan Eritsland, MD, PhD +47 22119100
Contact: Geir O Andersen, MD, PhD +47 22119100

Locations
Norway
Dept. of Cardiology, Oslo Univ. Hosp. Ulleval Recruiting
Oslo, Norway, N-0407
Contact: Jan Eritsland, MD, PhD     +47 22 11 91 00        
Principal Investigator: Shanmuganathan Limalanathan, MD            
Sponsors and Collaborators
Oslo University Hospital
Investigators
Study Chair: Jan Eritsland, MD, PhD Oslo Univ.Hosp. Ulleval
  More Information

No publications provided

Responsible Party: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT00922675     History of Changes
Other Study ID Numbers: Po 1506
Study First Received: June 16, 2009
Last Updated: June 19, 2012
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Data Protection Authority

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

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

ClinicalTrials.gov processed this record on May 21, 2013