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)

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