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REsearching Coronary REduction by Appropriately Targeting Euglycemia (RECREATE Pilot Study)

This study has been completed.
Sponsor:
Information provided by:
Population Health Research Institute
ClinicalTrials.gov Identifier:
NCT00640991
First received: March 18, 2008
Last updated: June 15, 2010
Last verified: June 2009
History of Changes
  Purpose

Insulin will safely reduce glucose levels in patients with acute ST-elevation myocardial infarction and admission hyperglycemia.


Condition Intervention Phase
Hyperglycemia
Cardiovascular Diseases
Myocardial Infarction
 Drug: glulisine insulin, glargine insulin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An International Multicentre Randomized Controlled Trial of Intensive Insulin Therapy Targeting Normoglycemia In Acute Myocardial Infarction: the RECREATE (REsearching Coronary REduction by Appropriately Targeting Euglycemia) Pilot Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Population Health Research Institute:

Primary Outcome Measures:
  • The 24-hour difference in mean glucose between the two study groups. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The difference in mean glucose level achieved at 7 days or hospital discharge (whichever is first) [ Time Frame: 7 days or discharge ] [ Designated as safety issue: No ]
  • The difference in mean glucose level achieved at 30 days between study groups [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Nonfatal recurrent myocardial infarction, nonfatal stroke, or cardiovascular death (as a composite and as separate outcomes) [ Time Frame: Discharge, 30 days, 90 days, 1 year ] [ Designated as safety issue: No ]
  • Rehospitalization for congestive heart failure [ Time Frame: Discharge, 30 days, 90 days, 1 year ] [ Designated as safety issue: No ]
  • All cause mortality [ Time Frame: Discharge, 30 days, 90 days, 1 year ] [ Designated as safety issue: No ]
  • Resuscitated cardiac arrest or life-threatening arrhythmia (as a composite and as separate outcomes) [ Time Frame: Discharge, 30 days, 90 days, 1 year ] [ Designated as safety issue: No ]
  • Cardiogenic shock [ Time Frame: Discharge, 30 days, 90 days, 1 year ] [ Designated as safety issue: No ]
  • Cardiac procedures [ Time Frame: Discharge, 30 days, 90 days, 1 year ] [ Designated as safety issue: No ]
  • Rehospitalization for any cause [ Time Frame: Discharge, 30 days, 90 days, 1 year ] [ Designated as safety issue: No ]
  • Symptomatic and severe hypoglycemic episodes [ Time Frame: Discharge, 30 days, 90 days, 1 year ] [ Designated as safety issue: Yes ]
  • Hypokalemic episodes [ Time Frame: Discharge ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 500
Study Start Date: April 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Patients assigned to the control arm will receive usual care for AMI, according to local practice of each participating centre.
Experimental: Intervention
The experimental arm will have an IV infusion of glulisine insulin started directly after randomization for at least 24 hours and for as long as CCU-level care is required, and the insulin infusion will be adjusted to achieve and maintain a target glucose range of 5.0-6.6 mmol/L (90-118 mg/dL). Once transferred to the ward, patients in the experimental arm will switch to glargine insulin and will continue this treatment for the remainder of their hospitalization and after hospital discharge, for a total duration of 30 days post randomization.
 Drug: glulisine insulin, glargine insulin
IV infusion of glulisine, SC injection of glargine
Other Name: Apidra, Lantus

Detailed Description:

Patients will be randomly assigned to either the control arm and will receive usual AMI care or the experimental arm, which will include routine AMI care as well as intensive therapy intervention.

In addition to the capillary blood glucose measurements obtained to titrate insulin doses in the experimental arm patients, laboratory plasma glucose will be drawn in all patients at randomization, 10, 24, 48, and 72 hours post randomization, 7 days post randomization (or hospital discharge if that occurs first), and 30 days post randomization.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Both nondiabetic patients and patients with non-insulin-requiring type 2 diabetes mellitus admitted with a suspected AMI are eligible if they meet the following criteria:

  • Signs or symptoms of AMI with definite ECG changes, defined as persistent ST-segment elevation (> or = than 1 mm)in two or more contiguous leads, or new left bundle branch block
  • Onset of symptoms within 24 hours before hospital presentation
  • Capillary blood glucose level on presentation > or = 8.0 mmol/L (144 mg/dL)

Exclusion Criteria:

  • Patient with conditions that REQUIRE the administration of insulin, including:

    • Type 1 diabetes mellitus, defined by a documented history of diabetes mellitus before the age of 30
    • Type 2 diabetes mellitus that was treated with insulin prior to AMI presentation
    • Type 2 diabetes mellitus that is known to be very poorly controlled (e.g. admission capillary blood glucose > 16.0 mmol/L (288 mg/dL)or marked elevation in glucose for which the site investigator plans to treat with insulin therapy)
  • A history of severe hypoglycemic episodes (defined as hypoglycemia with symptoms which the patient is unable to reverse without the assistance of another person) within the past two years
  • Known or suspected end-stage liver disease (due to the risk of hypoglycemia in the setting of liver dysfunction and consequent impaired regulation of glucose homeostasis)
  • Cardiogenic shock on admission (due to the inaccuracy of glucose meter readings)
  • Documented pregnancy
  • Any concomitant disease (e.g. cancer) that might limit life expectancy to less than 90 days
  • Anticipated poor adherence with study treatments or an other factor that might jeopardize 90-day follow-up (e.g. no fixed address, long distance to hospital, etc.)
  • Prior enrollment in this trial or current enrollment in another trial of ST-segment elevation myocardial infarction
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00640991

Locations
Argentina
Instituto Medico Adrogue
Adrogue,, Buenos Aires, Argentina
Canada, Ontario
Hamilton Health Sciences, General Site
Hamilton, Ontario, Canada, L8L 2X2
India
Assam Medical College Hospital
Dt. Dibrugarh, Assam, India, 786002
Lifeworth Super Specialty Hospital
Raipur, Chattisgarh, India, 492001
Post Graduate Institute of Medical
Rohtak, Haryana, India, 124001
St. Johns Medical College
Bangalore, Karnataka, India, 560034
Nanjappa Hospital
Shimoga, Karnataka, India, 577201
Baby Memorial Hospital
Calicut, Kerala, India, 673004
Caritas Hospital
Kottayam, Kerala, India, 686016
KEM Hospital
Mumbai, Maharashtra, India, 400012
MGIMS
Wardha, Maharashtra, India, 442102
Railway Hospital
Chennai, Tamilnadu, India, 600023
Avanti Institute of Cardiology
Nagpur, India, 440012
Sponsors and Collaborators
Population Health Research Institute
Investigators
Principal Investigator: Hertzel Gerstein, MD, MSc, FRCPC McMaster University
Principal Investigator: Salim Yusuf, DPhil, FRCPC, FRSC McMaster University
  More Information

No publications provided

Responsible Party: Dr. Hertzel Gerstein, Professor of Medicine, McMaster University
ClinicalTrials.gov Identifier: NCT00640991     History of Changes
Other Study ID Numbers: RECREATE Pilot
Study First Received: March 18, 2008
Last Updated: June 15, 2010
Health Authority: Canada: Health Canada
India: Drugs Controller General of India
India: Central Drugs Standard Control Organization
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Argentina: Ministry of Health

Keywords provided by Population Health Research Institute:
Clinical Trial
Insulin

Additional relevant MeSH terms:
Cardiovascular Diseases
Hyperglycemia
Infarction
Myocardial Infarction
Glucose Metabolism Disorders
Metabolic Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
 Heart Diseases
Vascular Diseases
Glargine
Insulin glulisine
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013