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Completed

NCT Number: NCT00640991

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

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

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Instituto Medico Adrogue, Adrogué, Buenos Aires, Argentina

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

glulisine insulin, glargine insulin

Drug

IV infusion of glulisine, SC injection of glargine

Other names: Apidra, Lantus

Primary outcomes

  1. The 24-hour difference in mean glucose between the two study groups.

    Time frame: 24 hours

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Population Health Research Institute

Other

Registry information

Official study 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

Acronym: RECREATE Pilot

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Mar 21, 2008
Registry last updated
Jun 16, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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