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

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Population Health Research Institute
• Treatments: Insulin; Insulin Glargine; Insulin glulisine; Insulin, Globin Zinc

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