Clinical trial NCT02021760: Reduction in Infarct Size by Remote Per-postconditioning in Patients With ST-elevation Myocardial Infarction
Official title: Reduction in Infarct Size by Remote Per-postconditioning in Patients With ST-elevation Myocardial Infarction in Stockholm (RECOND)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Myocardial Infarction
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2013-12-27
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Myocardial infarct size expressed as a percentage of the myocardium at risk determined by Cardiac Magnetic Resonance
timeFrame: 4-7 days following index event
Secondary outcomes:
measure: Myocardial infarct size expressed as a percentage to the myocardium at risk determined by Cardiac Magnetic Resonance
timeFrame: 6 months following index event
Other outcomes:
measure: Global left ventricular function determined by left ventricular ejection fraction determined by CMR.
timeFrame: 4-7 days and 6 months following index event
measure: Microvascular obstruction determined by CMR
timeFrame: 4-7 days following index event
measure: Quantified ECV (extracellular volume) in left ventricular as myocardium at risk
timeFrame: 4-7 days following index event
measure: Myocardial infarct size by CMR expressed as a percentage to the myocardium at risk determined by Bari or modified Approach Score with coronary angiography.
timeFrame: 5-7 days following index event
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Stockholm
country: Sweden
facility: Danderyds Hospital
city: Stockholm
country: Sweden
facility: Södersjukhuset
Study officials:
affiliation: Karolinska Institutet
name: John Pernow, Professor
role: PRINCIPAL_INVESTIGATOR
References: