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

Primary Purpose

Coronary Artery Disease, Myocardial Infarction

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Primary Percutaneous Coronary Intervention
Sponsored by
John Pernow
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Karolinska University Hospital
  • Danderyds Hospital
  • Södersjukhuset

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Remote Ischemic per-postconditioning

Sham

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Myocardial infarct size expressed as a percentage of the myocardium at risk determined by Cardiac Magnetic Resonance

Secondary Outcome Measures

Myocardial infarct size expressed as a percentage to the myocardium at risk determined by Cardiac Magnetic Resonance

Full Information

First Posted
December 20, 2013
Last Updated
February 8, 2016
Sponsor
John Pernow
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1. Study Identification

Unique Protocol Identification Number
NCT02021760
Brief Title
Reduction in Infarct Size by Remote Per-postconditioning in Patients With ST-elevation Myocardial Infarction
Acronym
RECOND
Official Title
Reduction in Infarct Size by Remote Per-postconditioning in Patients With ST-elevation Myocardial Infarction in Stockholm (RECOND)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
John Pernow

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Myocardial Infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Remote Ischemic per-postconditioning
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
The sham procedures include application of the cuff around the thigh but it is not inflated. Otheriwize normal primary PCI.
Intervention Type
Procedure
Intervention Name(s)
Primary Percutaneous Coronary Intervention
Intervention Description
Primary Percutanous Coronary Intervention is performed in both Groups.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Myocardial infarct size expressed as a percentage to the myocardium at risk determined by Cardiac Magnetic Resonance
Time Frame
6 months following index event
Other Pre-specified Outcome Measures:
Title
Global left ventricular function determined by left ventricular ejection fraction determined by CMR.
Time Frame
4-7 days and 6 months following index event
Title
Microvascular obstruction determined by CMR
Time Frame
4-7 days following index event
Title
Quantified ECV (extracellular volume) in left ventricular as myocardium at risk
Time Frame
4-7 days following index event
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Pernow, Professor
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska University Hospital
City
Stockholm
ZIP/Postal Code
S-17176
Country
Sweden
Facility Name
Danderyds Hospital
City
Stockholm
Country
Sweden
Facility Name
Södersjukhuset
City
Stockholm
Country
Sweden

12. IPD Sharing Statement

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

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