NCT02021760

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P25-P50 for not_applicable coronary-artery-disease

Timeline
Completed

Started May 2013

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 27, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

February 9, 2016

Status Verified

February 1, 2016

Enrollment Period

2 years

First QC Date

December 20, 2013

Last Update Submit

February 8, 2016

Conditions

Coronary Artery DiseaseMyocardial Infarction

Outcome Measures

Primary Outcomes (1)

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

    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

    6 months following index event

Other Outcomes (4)

  • 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

  • +1 more other outcomes

Study Arms (2)

Remote Ischemic per-postconditioning

ACTIVE COMPARATOR

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

SHAM COMPARATOR

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

Primary Percutaneous Coronary InterventionPROCEDURE

Primary Percutanous Coronary Intervention is performed in both Groups.

Remote Ischemic per-postconditioningSham

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Karolinska University Hospital

Stockholm, S-17176, Sweden

Location

Danderyds Hospital

Stockholm, Sweden

Location

Södersjukhuset

Stockholm, Sweden

Location

MeSH Terms

Conditions

Coronary Artery DiseaseMyocardial Infarction

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • John Pernow, Professor

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 20, 2013

First Posted

December 27, 2013

Study Start

May 1, 2013

Primary Completion

May 1, 2015

Study Completion

November 1, 2015

Last Updated

February 9, 2016

Record last verified: 2016-02

Locations

SE(3)