Reappraisal of GIK in Acute STEMI by Pre-hospital Administration

NCT02591927 | Unknown Phase 3

• 1 other identifier: 32003B_159727
• Study Type: interventional
• Target: 334
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is:

1. 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. 2.to explore the putative cardioprotective mechanisms of pre-hospital GIK administration

Conditions

Myocardial Infarction

Keywords

myocardial infarction; glucose-insulin-potassium

Outcome Measures

Primary Outcomes (1)

• Infarct size quantified by Late Gadolinium Enhancement using Cardiovascular Magnetic Resonance

  12 to 72 hours after the acute event

Secondary Outcomes (3)

• The severity of ischemia/reperfusion injury (myocardial edema, microvascular obstruction and myocardial hemorrhage)

  12 to 72 hours after the acute event

• Major Adverse Cardiovascular Events

  at 7-day, 30-day, 4-month and at 1-year follow-up

• Post-infarction Remodeling

  4-month follow-up

Study Arms (2)

Glucose-Insulin-Potassium

ACTIVE COMPARATOR

Rackley's Glucose-Insulin-Potassium formula consisting of 30% glucose (300 mg/L), 50 units of regular insulin per liter and 80 mEqu of KCL per liter.

Drug: Glucose-Insulin-Potassium

Glucose 5%

PLACEBO COMPARATOR

Glucose 5%

Drug: Glucose 5%

Interventions

Glucose-Insulin-Potassium DRUG

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).

Also known as: GIK

Glucose-Insulin-Potassium

Glucose 5% DRUG

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

Also known as: Placebo

Glucose 5%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with the diagnosis of acute STEMI
• age≥ 18
• informed consent for study participation.

You may not qualify if:

• end-stage renal failure requiring dialysis,
• prior MI or coronary revascularization (PCI or CABG),
• active malignances,
• Pregnancy,
• Hemodynamic instability (systolic blood pressure \<100mmHg or significant pulmonary congestion defined as O2 saturation \<90% on ambient air at pulso-oxymetry)
• total ischemic time more than 8 hours (from symptoms onset to infarct-related artery mechanical re-opening)
• evidence at diagnostic angiograms of TIMI flow-grade \>1 of infarct-related artery or significant epicardial collaterals to the ischemic myocardium at risk (Rentrop flow-grade \>1),
• moderate-to-severe renal failure (estimated glomerular filtration rate \< 30 ml/min/1.73 m2 by Cockcroft-Gault formula) and
• urgent CABG.

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead

Study Sites (1)

Centre Hospitalier Universitaire Vaudois - CHUV

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (2)

• Grossman AN, Opie LH, Beshansky JR, Ingwall JS, Rackley CE, Selker HP. Glucose-insulin-potassium revived: current status in acute coronary syndromes and the energy-depleted heart. Circulation. 2013 Mar 5;127(9):1040-8. doi: 10.1161/CIRCULATIONAHA.112.130625. No abstract available.

  PMID: 23459576 BACKGROUND

• Selker HP, Beshansky JR, Sheehan PR, Massaro JM, Griffith JL, D'Agostino RB, Ruthazer R, Atkins JM, Sayah AJ, Levy MK, Richards ME, Aufderheide TP, Braude DA, Pirrallo RG, Doyle DD, Frascone RJ, Kosiak DJ, Leaming JM, Van Gelder CM, Walter GP, Wayne MA, Woolard RH, Opie LH, Rackley CE, Apstein CS, Udelson JE. Out-of-hospital administration of intravenous glucose-insulin-potassium in patients with suspected acute coronary syndromes: the IMMEDIATE randomized controlled trial. JAMA. 2012 May 9;307(18):1925-33. doi: 10.1001/jama.2012.426. Epub 2012 Mar 27.

  PMID: 22452807 BACKGROUND

MeSH Terms

Conditions

Myocardial Infarction

Interventions

glucose-insulin-potassium cardioplegic solution

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Pier-Giorgio Masci, MD

  Centre Hospitalier Universitaire Vaudois

  PRINCIPAL INVESTIGATOR

• Juerg Schwitter, MD

  Centre Hospitalier Universitaire Vaudois

  STUDY DIRECTOR

• Pierre Vogt, MD

  Centre Hospitalier Universitaire Vadois

  STUDY CHAIR

• Eric Eeckhout, MD

  Centre Hospitalier Universitaire Vaudois

  STUDY CHAIR

• Juan-Fernando Iglesias

  Centre Hospitalier Universitaire Vaudois

  STUDY CHAIR

• Olivier Muller

  Centre Hospitalier Universitaire Vaudois

  STUDY CHAIR

• Olivier Hugli

  Centre Hospitalier Universitaire Vaudois

  STUDY CHAIR

• Fabrice Dami

  Centre Hospitalier Universitaire Vaudois

  STUDY CHAIR

• Pierre Monney

  Centre Hospitalier Universitaire Vaudois

  STUDY CHAIR

Central Study Contacts

Pier-Giorgio Masci, MD

CONTACT

79-556-48-63; pgmasci@gmail.com

Juerg Schwitter, MD

CONTACT

79-556-83-27; jurg.schwitter@chuv.ch

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 28, 2015
• First Posted: October 30, 2015
• Study Start: February 1, 2016
• Primary Completion: February 1, 2019
• Last Updated: October 30, 2015

Record last verified: 2015-10

Locations

CH (1)