Postconditioning in ST-elevation Myocardial Infarction

Myocardial Infarction Clinical Trial

— POSTEMI  

Official title:

Postconditioning in ST-elevation Myocardial Infarction Treated With Primary PCI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00922675
• Other study ID #: Po 1506
• Status: Completed
• Phase: N/A
• First received: June 16, 2009
• Last updated: September 26, 2016
• Start date: June 2009
• Est. completion date: August 2013

Study information

• Verified date: September 2016
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research EthicsNorway: Data Protection Authority
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 272
• Est. completion date: August 2013
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

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 intervention
After opening of IRA and establishment of TIMI-flow grade 2 or 3, the control group continues the procedure with stenting.

Locations

Country	Name	City	State
Norway	Dept. of Cardiology, Oslo Univ. Hosp. Ulleval	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infarct size, assessed by MRI		4 months	Yes
Secondary	Myocardial blushing grade		assessed at the end of PCI procedure	No
Secondary	ST-resolution in ECG		Assessed after 1 hour	No
Secondary	Troponin-T and CK-MB		peak release values	No
Secondary	Echocardiographic evaluation of left ventricular function including speckle-tracking measurement.	Assesment of LV function. Comparison with CMR in the whole study population and between treatment groups.	assessed at baseline, 4 months and1 year	No
Secondary	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.	Yes
Secondary	Myocardial salvage	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.	Baseline to 4 months	No