Clinical trial NCT00640991: REsearching Coronary REduction by Appropriately Targeting Euglycemia (RECREATE Pilot Study)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hyperglycemia
Cardiovascular Diseases
Myocardial Infarction
Keywords: Clinical Trial
Insulin
Lead sponsor: Population Health Research Institute
Sponsor class: OTHER
First posted: 2008-03-21
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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 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

Primary outcomes:
measure: The 24-hour difference in mean glucose between the two study groups.
timeFrame: 24 hours
Secondary outcomes:
measure: The difference in mean glucose level achieved at 7 days or hospital discharge (whichever is first)
timeFrame: 7 days or discharge
measure: The difference in mean glucose level achieved at 30 days between study groups
timeFrame: 30 days
measure: Nonfatal recurrent myocardial infarction, nonfatal stroke, or cardiovascular death (as a composite and as separate outcomes)
timeFrame: Discharge, 30 days, 90 days, 1 year
measure: Rehospitalization for congestive heart failure
timeFrame: Discharge, 30 days, 90 days, 1 year
measure: All cause mortality
timeFrame: Discharge, 30 days, 90 days, 1 year
measure: Resuscitated cardiac arrest or life-threatening arrhythmia (as a composite and as separate outcomes)
timeFrame: Discharge, 30 days, 90 days, 1 year
measure: Cardiogenic shock
timeFrame: Discharge, 30 days, 90 days, 1 year
measure: Cardiac procedures
timeFrame: Discharge, 30 days, 90 days, 1 year
measure: Rehospitalization for any cause
timeFrame: Discharge, 30 days, 90 days, 1 year
measure: Symptomatic and severe hypoglycemic episodes
timeFrame: Discharge, 30 days, 90 days, 1 year
measure: Hypokalemic episodes
timeFrame: Discharge
Other outcomes:
Locations:
city: Adrogue,
country: Argentina
facility: Instituto Medico Adrogue
state: Buenos Aires
city: Hamilton
country: Canada
facility: Hamilton Health Sciences, General Site
state: Ontario
city: Dt. Dibrugarh
country: India
facility: Assam Medical College Hospital
state: Assam
city: Raipur
country: India
facility: Lifeworth Super Specialty Hospital
state: Chattisgarh
city: Rohtak
country: India
facility: Post Graduate Institute of Medical
state: Haryana
city: Bangalore
country: India
facility: St. Johns Medical College
state: Karnataka
city: Shimoga
country: India
facility: Nanjappa Hospital
state: Karnataka
city: Calicut
country: India
facility: Baby Memorial Hospital
state: Kerala
city: Kottayam
country: India
facility: Caritas Hospital
state: Kerala
city: Mumbai
country: India
facility: KEM Hospital
state: Maharashtra
city: Wardha
country: India
facility: MGIMS
state: Maharashtra
city: Chennai
country: India
facility: Railway Hospital
state: Tamilnadu
city: Nagpur
country: India
facility: Avanti Institute of Cardiology
Study officials:
affiliation: McMaster University
name: Hertzel Gerstein, MD, MSc, FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Salim Yusuf, DPhil, FRCPC, FRSC
role: PRINCIPAL_INVESTIGATOR
References: