Status:
COMPLETED
REsearching Coronary REduction by Appropriately Targeting Euglycemia (RECREATE Pilot Study)
Lead Sponsor:
Population Health Research Institute
Conditions:
Hyperglycemia
Cardiovascular Diseases
Eligibility:
All Genders
Phase:
PHASE3
Brief Summary
Insulin will safely reduce glucose levels in patients with acute ST-elevation myocardial infarction and admission hyperglycemia.
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2010
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00640991
Start Date
April 1 2008
End Date
June 1 2010
Last Update
June 16 2010
Active Locations (13)
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1
Instituto Medico Adrogue
Adrogué, Buenos Aires, Argentina
2
Hamilton Health Sciences, General Site
Hamilton, Ontario, Canada, L8L 2X2
3
Assam Medical College Hospital
Dt. Dibrugarh, Assam, India, 786002
4
Lifeworth Super Specialty Hospital
Raipur, Chhattisgarh, India, 492001