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

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

• 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.

Study Overview

• Status: Completed
• Conditions: Myocardial Infarction; Coronary Artery Disease
• Intervention / Treatment: Procedure: Primary Percutaneous Coronary Intervention

Detailed Description

See above. 3 patients left to include.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden
    • Södersjukhuset
  • Stockholm, Sweden
    • Danderyds Hospital
  • Stockholm, Sweden, S-17176
    • Karolinska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Remote Ischemic per-postconditioning; 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.	Procedure: Primary Percutaneous Coronary Intervention; Primary Percutanous Coronary Intervention is performed in both Groups.
Sham Comparator: Sham; The sham procedures include application of the cuff around the thigh but it is not inflated. Otheriwize normal primary PCI.	Procedure: Primary Percutaneous Coronary Intervention; Primary Percutanous Coronary Intervention is performed in both Groups.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

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

Other Outcome Measures

Outcome Measure	Time Frame
Global left ventricular function determined by left ventricular ejection fraction determined by CMR.	4-7 days and 6 months following index event
Microvascular obstruction determined by CMR	4-7 days following index event
Quantified ECV (extracellular volume) in left ventricular as myocardium at risk	4-7 days following index event
Myocardial infarct size by CMR expressed as a percentage to the myocardium at risk determined by Bari or modified Approach Score with coronary angiography.	5-7 days following index event

Collaborators and Investigators

• Sponsor: John Pernow
• Investigators: Principal Investigator: John Pernow, Professor, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: December 20, 2013
• First Submitted That Met QC Criteria: December 20, 2013
• First Posted (Estimate): December 27, 2013

Study Record Updates

• Last Update Posted (Estimate): February 9, 2016
• Last Update Submitted That Met QC Criteria: February 8, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Infarction; Infarction; Coronary Artery Disease; ST Elevation Myocardial Infarction
• Other Study ID Numbers: RECOND