Postconditioning in ST-elevation Myocardial Infarction (POSTEMI)

University of Oslo (UIO)

Status: Completed

Conditions: Myocardial Infarction

Treatments: Procedure: Control intervention; Procedure: Postconditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT00922675

Po 1506

Details and patient eligibility

About

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.

Enrollment: 272 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

272 participants in 2 patient groups

Postconditioning

Experimental group

Description:

Active arm:Postconditioning protocol before routine PCI/stenting of an occluded coronary artery

Treatment:

Procedure: Postconditioning

Control

Other group

Description:

Control arm: Routine PCI/stenting of an occluded coronary artery without postconditioning

Treatment:

Procedure: Control intervention