Reappraisal of GIK in Acute STEMI by Pre-hospital Administration

NCT02591927 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 334

Last updated 2015-10-30

No results posted yet for this study

Summary

The purpose of this study is:

1. to assess whether pre-hospital glucose-insulin-potassium (GIK) administration in acute STEMI patients would reduce infarct size and ischemia/reperfusion damage using comprehensive tissue characterization by cardiovascular magnetic resonance (CMR) at an early post-infarction phase.
2. to explore the putative cardioprotective mechanisms of pre-hospital GIK administration

Conditions

Interventions

DRUG

Glucose-Insulin-Potassium

Rackley's GIK formula by continuous I.V. infusion at 1.5 ml/Kg/hour for 12 hours (about 100 ml/hour for a 70 kg patient).

DRUG

Glucose 5%

Glucose 5% (Placebo) by continuous I.V. infusion at 1.5ml/kg/hour for 12 hours (about 100 ml/hour for 70 Kg patient)

Sponsors & Collaborators

  • Centre Hospitalier Universitaire Vaudois

    lead OTHER

Principal Investigators

  • Pier-Giorgio Masci, MD · Centre Hospitalier Universitaire Vaudois

  • Juerg Schwitter, MD · Centre Hospitalier Universitaire Vaudois

  • Pierre Vogt, MD · Centre Hospitalier Universitaire Vadois

  • Eric Eeckhout, MD · Centre Hospitalier Universitaire Vaudois

  • Juan-Fernando Iglesias · Centre Hospitalier Universitaire Vaudois

  • Olivier Muller · Centre Hospitalier Universitaire Vaudois

  • Olivier Hugli · Centre Hospitalier Universitaire Vaudois

  • Fabrice Dami · Centre Hospitalier Universitaire Vaudois

  • Pierre Monney · Centre Hospitalier Universitaire Vaudois

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2019-02-28

Countries

  • Switzerland

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02591927 on ClinicalTrials.gov