Reduction in Infarct Size by Remote Per-postconditioning in Patients With ST-elevation Myocardial Infarction

NCT ID: NCT02021760

Last Updated: 2016-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2015-11-30

Brief Summary

• Trial objective: To test the hypothesis that remote per-postconditioning in connection with primary PCI will reduce myocardial infarct size patients with STEMI.
• Trial Design: Placebo controlled randomized study with parallel groups
• Primary Endpoint: Myocardial infarct size expressed as a percentage of the myocardium at risk determined by Cardiac Magnetic Resonance (CMR) day 4-7
• Efficacy Parameters: Myocardial infarct size expressed as a percentage to the myocardium at risk determined by CMR at 6 months.
• Global left ventricular function determined by left ventricular ejection fraction determined by CMR.
• Microvascular obstruction determined by CMR day 4-7. Quantified ECV (extracellular volume) in left ventricular as myocardium at risk day 4-7 and remodelling parameters day 180.
• Safety Parameters: Major adverse cardiovascular events.

Detailed Description

See above. 3 patients left to include.

Conditions

Coronary Artery Disease; Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Remote Ischemic per-postconditioning

Remote conditioning is induced by inflation of a blood pressure cuff around the left thigh to 200 mmHg or 20 mmHg above systolic blood pressure (if \>180 mmHg) for 5 min followed by deflation for 5 min. At least one of these conditioning cycles is performed before PCI is initiated. If time allows, cycles of remote conditioning (5 min leg ischemia and 5 min reperfusion) are repeated until PCI is performed. Following reperfusion, defined as first balloon inflation, four additional cycles of remote conditioning will be performed.

Group Type: ACTIVE_COMPARATOR

Primary Percutaneous Coronary Intervention

Intervention Type: PROCEDURE

Primary Percutanous Coronary Intervention is performed in both Groups.

Sham

The sham procedures include application of the cuff around the thigh but it is not inflated.

Otheriwize normal primary PCI.

Group Type: SHAM_COMPARATOR

Primary Percutaneous Coronary Intervention

Intervention Type: PROCEDURE

Primary Percutanous Coronary Intervention is performed in both Groups.

Interventions

Primary Percutaneous Coronary Intervention

Primary Percutanous Coronary Intervention is performed in both Groups.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patient planned for primary PCI.
• Chest pain indicating myocardial ischemia with a duration >30 minutes and < 6 hours prior to randomization.
• ST elevations >0.1 mV (>0.2 mV in V2-V3) in > two contiguous leads in V1-V6.
• Informed consent.

Exclusion Criteria

• Previous myocardial infarction based on medical history or Q-wave on ECG in other area
• Left Bundle Branch Block on ECG.
• Previous CABG
• Cardiac arrest
• Any contraindication for CMR.
• Clinical symptoms of claudication
• Treatment with glibenclamide or cyclosporine on admission.
• Any condition that may interfere with the possibility for the patient to comply with or complete the study protocol.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

John Pernow

OTHER

Sponsor Role: lead

Responsible Party

John Pernow

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

John Pernow, Professor

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

Karolinska University Hospital

Stockholm, , Sweden

Danderyds Hospital

Stockholm, , Sweden

Södersjukhuset

Stockholm, , Sweden

Countries

Sweden

Other Identifiers

RECOND

Identifier Type: -

Identifier Source: org_study_id