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 December 2013 by Karolinska Institutet
Sponsor:
Information provided by (Responsible Party):
John Pernow, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT02021760
First received: December 20, 2013
Last updated: NA
Last verified: December 2013
History: No changes posted
  Purpose
  • 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.

Condition Intervention
Coronary Artery Disease
Myocardial Infarction
Procedure: Primary Percutaneous Coronary Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Reduction in Infarct Size by Remote Per-postconditioning in Patients With ST-elevation Myocardial Infarction in Stockholm (RECOND)

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • 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 ]

Estimated Enrollment: 120
Study Start Date: May 2013
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Sham Comparator: Sham
The sham procedures include application of the cuff around the thigh but it is not inflated
Procedure: Primary Percutaneous Coronary Intervention

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02021760

Contacts
Contact: John Pernow, Professor john.pernow@ki.se
Contact: Felix Bohm, PhD, MD felix.bohm@ki.se

Locations
Sweden
Karolinska University Hospital Recruiting
Stockholm, Sweden, S-17176
Contact: John Pernow, Professor       john.pernow@ki.se   
Contact: Felix Bohm, MD, PhD       felix.bohm@ki.se   
Principal Investigator: John Pernow, Professor         
Sub-Investigator: Felix Bohm, MD, PhD         
Sub-Investigator: Dinos Verouhis, MD         
Sub-Investigator: Loghman Henareh, MD, PhD         
Sub-Investigator: Peder Sorensson, MD, PhD         
Sub-Investigator: Nawsad Saleh, MD, PhD         
Sub-Investigator: Adrian Gonon, MD, PhD         
Danderyds Hospital Recruiting
Stockholm, Sweden
Contact: Jonas Persson       jonas.persson@ds.se   
Principal Investigator: Jonas Persson, MD, PhD         
Södersjukhuset Recruiting
Stockholm, Sweden
Contact: Nils Witt, MD, PhD       nils.witt@sodersjukhuset.se   
Contact: Per Tornvall, MD, PhD       per.tornvall@ki.se   
Principal Investigator: Nils Witt, MD, PhD         
Sub-Investigator: Per Tornvall, MD, PhD         
Sponsors and Collaborators
John Pernow
Investigators
Principal Investigator: John Pernow, Professor Karolinska Institutet
  More Information

No publications provided

Responsible Party: John Pernow, Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02021760     History of Changes
Other Study ID Numbers: RECOND
Study First Received: December 20, 2013
Last Updated: December 20, 2013
Health Authority: Sweden: The National Board of Health and Welfare

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Infarction
Myocardial Infarction
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Ischemia
Pathologic Processes
Necrosis

ClinicalTrials.gov processed this record on August 28, 2014