Myocardial Infarction
Conditions
Keywords
ST-elevation myocardial infarction
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.
Interventions
PROCEDUREPostconditioning
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.
PROCEDUREControl intervention
After opening of IRA and establishment of TIMI-flow grade 2 or 3, the control group continues the procedure with stenting.
Sponsors
Oslo University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Infarct size, assessed by MRI | 4 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ST-resolution in ECG | Assessed after 1 hour | — |
| Troponin-T and CK-MB | peak release values | — |
| Myocardial blushing grade | assessed at the end of PCI procedure | — |
| 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. | — |
| Myocardial salvage | 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. |
| Echocardiographic evaluation of left ventricular function including speckle-tracking measurement. | assessed at baseline, 4 months and1 year | Assesment of LV function. Comparison with CMR in the whole study population and between treatment groups. |
Countries
Norway
Outcome results
None listed