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

Not Applicable

Completed

• Conditions: Myocardial Infarction; Coronary Artery Disease
• Interventions: Procedure: Primary Percutaneous Coronary Intervention

• Registration Number: NCT02021760
• Lead Sponsor: John Pernow

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.

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-12-20
• Study First Submitted QC: 2013-12-20
• Study First Posted: 2013-12-27
• Primary Completion: 2015-05
• Study Completion: 2015-11
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-08
• Last Update Posted: 2016-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remote Ischemic per-postconditioning	Primary Percutaneous Coronary Intervention	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.
Sham	Primary Percutaneous Coronary Intervention	The sham procedures include application of the cuff around the thigh but it is not inflated. Otheriwize normal primary PCI.

Primary Outcome Measures

Name	Time	Method
Myocardial infarct size expressed as a percentage of the myocardium at risk determined by Cardiac Magnetic Resonance	4-7 days following index event

Secondary Outcome Measures

Name	Time	Method
Myocardial infarct size expressed as a percentage to the myocardium at risk determined by Cardiac Magnetic Resonance	6 months following index event

Trial Locations

Locations (3)

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden

Södersjukhuset; 🇸🇪 Stockholm, Sweden

Danderyds Hospital; 🇸🇪 Stockholm, Sweden