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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2015 by Karolinska Institutet
Sponsor:
Information provided by (Responsible Party):
John Pernow, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT02021760
First received: December 20, 2013
Last updated: April 17, 2015
Last verified: April 2015

December 20, 2013
April 17, 2015
May 2013
April 2015   (final data collection date for primary outcome measure)
Myocardial infarct size expressed as a percentage of the myocardium at risk determined by Cardiac Magnetic Resonance [ Time Frame: 4-7 days following index event ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT02021760 on ClinicalTrials.gov Archive Site
Myocardial infarct size expressed as a percentage to the myocardium at risk determined by Cardiac Magnetic Resonance [ Time Frame: 6 months following index event ] [ Designated as safety issue: No ]
Same as current
  • Global left ventricular function determined by left ventricular ejection fraction determined by CMR. [ Time Frame: 4-7 days and 6 months following index event ] [ Designated as safety issue: No ]
  • Microvascular obstruction determined by CMR [ Time Frame: 4-7 days following index event ] [ Designated as safety issue: No ]
  • Quantified ECV (extracellular volume) in left ventricular as myocardium at risk [ Time Frame: 4-7 days following index event ] [ Designated as safety issue: No ]
  • Myocardial infarct size by CMR expressed as a percentage to the myocardium at risk determined by Bari or modified Approach Score with coronary angiography. [ Time Frame: 5-7 days following index event ] [ Designated as safety issue: No ]
Same as current
 
Reduction in Infarct Size by Remote Per-postconditioning in Patients With ST-elevation Myocardial Infarction
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.

See above. 3 patients left to include.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Coronary Artery Disease
  • Myocardial Infarction
Procedure: Primary Percutaneous Coronary Intervention
Primary Percutanous Coronary Intervention is performed in both Groups.
  • 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.
    Intervention: Procedure: Primary Percutaneous Coronary Intervention
  • Sham Comparator: Sham

    The sham procedures include application of the cuff around the thigh but it is not inflated.

    Otheriwize normal primary PCI.

    Intervention: Procedure: Primary Percutaneous Coronary Intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
October 2015
April 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: John Pernow, Professor john.pernow@ki.se
Contact: Felix Bohm, PhD, MD felix.bohm@ki.se
Sweden
 
NCT02021760
RECOND
Yes
John Pernow, Karolinska Institutet
John Pernow
Not Provided
Principal Investigator: John Pernow, Professor Karolinska Institutet
Karolinska Institutet
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP