Postconditioning in ST-elevation Myocardial Infarction
POSTEMI
1 other identifier
interventional
272
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 16, 2009
CompletedFirst Posted
Study publicly available on registry
June 17, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedSeptember 27, 2016
September 1, 2016
3.2 years
June 16, 2009
September 26, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Infarct size, assessed by MRI
4 months
Secondary Outcomes (6)
Myocardial blushing grade
assessed at the end of PCI procedure
ST-resolution in ECG
Assessed after 1 hour
Troponin-T and CK-MB
peak release values
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.
- +1 more secondary outcomes
Study Arms (2)
Postconditioning
EXPERIMENTALActive arm:Postconditioning protocol before routine PCI/stenting of an occluded coronary artery
Control
OTHERControl arm: Routine PCI/stenting of an occluded coronary artery without postconditioning
Interventions
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.
After opening of IRA and establishment of TIMI-flow grade 2 or 3, the control group continues the procedure with stenting.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dept. of Cardiology, Oslo Univ. Hosp. Ulleval
Oslo, N-0407, Norway
Related Publications (2)
Tollefsen IM, Shetelig C, Seljeflot I, Eritsland J, Hoffmann P, Andersen GO. High levels of interleukin-6 are associated with final infarct size and adverse clinical events in patients with STEMI. Open Heart. 2021 Dec;8(2):e001869. doi: 10.1136/openhrt-2021-001869.
PMID: 34933964DERIVEDLimalanathan S, Andersen GO, Klow NE, Abdelnoor M, Hoffmann P, Eritsland J. Effect of ischemic postconditioning on infarct size in patients with ST-elevation myocardial infarction treated by primary PCI results of the POSTEMI (POstconditioning in ST-Elevation Myocardial Infarction) randomized trial. J Am Heart Assoc. 2014 Apr 23;3(2):e000679. doi: 10.1161/JAHA.113.000679.
PMID: 24760962DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jan Eritsland, MD, PhD
Oslo Univ.Hosp. Ulleval
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Consultant Cardiology
Study Record Dates
First Submitted
June 16, 2009
First Posted
June 17, 2009
Study Start
June 1, 2009
Primary Completion
August 1, 2012
Study Completion
August 1, 2013
Last Updated
September 27, 2016
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will not share