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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00640991
Recruitment Status : Completed
First Posted : March 21, 2008
Last Update Posted : June 16, 2010
Information provided by:
Population Health Research Institute

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

Condition or disease Intervention/treatment Phase
Hyperglycemia Cardiovascular Diseases Myocardial Infarction Drug: glulisine insulin, glargine insulin Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : April 2008
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. The 24-hour difference in mean glucose between the two study groups. [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. The difference in mean glucose level achieved at 7 days or hospital discharge (whichever is first) [ Time Frame: 7 days or discharge ]
  2. The difference in mean glucose level achieved at 30 days between study groups [ Time Frame: 30 days ]
  3. 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 ]
  4. Rehospitalization for congestive heart failure [ Time Frame: Discharge, 30 days, 90 days, 1 year ]
  5. All cause mortality [ Time Frame: Discharge, 30 days, 90 days, 1 year ]
  6. Resuscitated cardiac arrest or life-threatening arrhythmia (as a composite and as separate outcomes) [ Time Frame: Discharge, 30 days, 90 days, 1 year ]
  7. Cardiogenic shock [ Time Frame: Discharge, 30 days, 90 days, 1 year ]
  8. Cardiac procedures [ Time Frame: Discharge, 30 days, 90 days, 1 year ]
  9. Rehospitalization for any cause [ Time Frame: Discharge, 30 days, 90 days, 1 year ]
  10. Symptomatic and severe hypoglycemic episodes [ Time Frame: Discharge, 30 days, 90 days, 1 year ]
  11. Hypokalemic episodes [ Time Frame: Discharge ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00640991

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Instituto Medico Adrogue
Adrogue,, Buenos Aires, Argentina
Canada, Ontario
Hamilton Health Sciences, General Site
Hamilton, Ontario, Canada, L8L 2X2
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
Wardha, Maharashtra, India, 442102
Railway Hospital
Chennai, Tamilnadu, India, 600023
Avanti Institute of Cardiology
Nagpur, India, 440012
Sponsors and Collaborators
Population Health Research Institute
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Principal Investigator: Hertzel Gerstein, MD, MSc, FRCPC McMaster University
Principal Investigator: Salim Yusuf, DPhil, FRCPC, FRSC McMaster University
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Responsible Party: Dr. Hertzel Gerstein, Professor of Medicine, McMaster University Identifier: NCT00640991    
Other Study ID Numbers: RECREATE Pilot
First Posted: March 21, 2008    Key Record Dates
Last Update Posted: June 16, 2010
Last Verified: June 2009
Keywords provided by Population Health Research Institute:
Clinical Trial
Additional relevant MeSH terms:
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Myocardial Infarction
Cardiovascular Diseases
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Vascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Insulin Glargine
Insulin glulisine
Hypoglycemic Agents
Physiological Effects of Drugs