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CompletedNCT02021760RECONDUpdated Feb 9, 2016

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

An interventional study of Primary Percutaneous Coronary Intervention in Coronary Artery Disease and Myocardial Infarction, sponsored by John Pernow. Completed at 3 sites in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-02-09.

Sponsored by John Pernow · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.
Read the detailed description

See above. 3 patients left to include.

02

Conditions studied

03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's planned enrollment of 120 is close to the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

This is the only study on the registry with John Pernow as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • 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. Otheriwize normal primary PCI.

    Procedure: Primary Percutaneous Coronary Intervention

Interventions

  • ProcedurePrimary Percutaneous Coronary Intervention

    Primary Percutanous Coronary Intervention is performed in both Groups.

06

What researchers measure

Primary outcomes

  1. 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 outcomes

  1. 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 outcomes

  1. Global left ventricular function determined by left ventricular ejection fraction determined by CMR.

    Time frame: 4-7 days and 6 months following index event

  2. Microvascular obstruction determined by CMR

    Time frame: 4-7 days following index event

  3. Quantified ECV (extracellular volume) in left ventricular as myocardium at risk

    Time frame: 4-7 days following index event

  4. 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

07

Study locations

3 sites
  • Karolinska University Hospital
    Stockholm, S-17176, Sweden
  • Danderyds Hospital
    Stockholm, Sweden
  • Södersjukhuset
    Stockholm, Sweden
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02021760
Lead sponsor
John Pernow
Responsible party
John Pernow (Professor, Karolinska Institutet) — Sponsor-investigator
First posted
Dec 27, 2013
Start date
May 2013
Primary completion
May 2015
Completion
Nov 2015
Last update
Feb 9, 2016

Study contacts

John Pernow, Professor
principal investigator · Karolinska Institutet

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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