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

Not Applicable

Completed

• Conditions: Myocardial Infarction; Coronary Artery Disease

• 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

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

Danderyds Hospital; 🇸🇪 Stockholm, Sweden

Södersjukhuset; 🇸🇪 Stockholm, Sweden