Clinical trial NCT00922675: Postconditioning in ST-elevation Myocardial Infarction
Official title: Postconditioning in ST-elevation Myocardial Infarction Treated With Primary PCI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Infarction
Keywords: ST-elevation myocardial infarction
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2009-06-17
Enrollment: 272
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Infarct size, assessed by MRI
timeFrame: 4 months
Secondary outcomes:
measure: Myocardial blushing grade
timeFrame: assessed at the end of PCI procedure
measure: ST-resolution in ECG
timeFrame: Assessed after 1 hour
measure: Troponin-T and CK-MB
timeFrame: peak release values
measure: Echocardiographic evaluation of left ventricular function including speckle-tracking measurement.
timeFrame: assessed at baseline, 4 months and1 year
measure: Incidence of treated arrhythmias and heart failure during initial hospitalization Incidence of death, non-fatal myocardial infarction, unstable angina, heart failure, and cerebrovascular disease
timeFrame: 1-year follow up.
measure: Myocardial salvage
timeFrame: Baseline to 4 months
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Dept. of Cardiology, Oslo Univ. Hosp. Ulleval
Study officials:
affiliation: Oslo Univ.Hosp. Ulleval
name: Jan Eritsland, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: Limalanathan 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.