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

John Pernow

Status: Completed

Conditions: Coronary Artery Disease; Myocardial Infarction

Treatments: Procedure: Primary Percutaneous Coronary Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02021760

RECOND

Details and patient eligibility

About

• 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.

Full description

See above. 3 patients left to include.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Remote Ischemic per-postconditioning

Active Comparator group

Description:

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.

Treatment:

Procedure: Primary Percutaneous Coronary Intervention

Sham

Sham Comparator group

Description:

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

Treatment:

Procedure: Primary Percutaneous Coronary Intervention