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Insulin will safely reduce glucose levels in patients with acute ST-elevation myocardial infarction and admission hyperglycemia.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Patients assigned to the control arm will receive usual care for AMI, according to local practice of each participating centre. | |
| Intervention | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| glulisine insulin, glargine insulin | Drug | IV infusion of glulisine, SC injection of glargine |
|
| Measure | Description | Time Frame |
|---|---|---|
| The 24-hour difference in mean glucose between the two study groups. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| The difference in mean glucose level achieved at 7 days or hospital discharge (whichever is first) | 7 days or discharge | |
| The difference in mean glucose level achieved at 30 days between study groups | 30 days |
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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:
Exclusion Criteria:
Patient with conditions that REQUIRE the administration of insulin, including:
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
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| Name | Affiliation | Role |
|---|---|---|
| Hertzel Gerstein, MD, MSc, FRCPC | McMaster University | Principal Investigator |
| Salim Yusuf, DPhil, FRCPC, FRSC | McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Medico Adrogue | Adrogué | Buenos Aires | Argentina | |||
| Hamilton Health Sciences, General Site |
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| Nonfatal recurrent myocardial infarction, nonfatal stroke, or cardiovascular death (as a composite and as separate outcomes) | Discharge, 30 days, 90 days, 1 year |
| Rehospitalization for congestive heart failure | Discharge, 30 days, 90 days, 1 year |
| All cause mortality | Discharge, 30 days, 90 days, 1 year |
| Resuscitated cardiac arrest or life-threatening arrhythmia (as a composite and as separate outcomes) | Discharge, 30 days, 90 days, 1 year |
| Cardiogenic shock | Discharge, 30 days, 90 days, 1 year |
| Cardiac procedures | Discharge, 30 days, 90 days, 1 year |
| Rehospitalization for any cause | Discharge, 30 days, 90 days, 1 year |
| Symptomatic and severe hypoglycemic episodes | Discharge, 30 days, 90 days, 1 year |
| Hypokalemic episodes | Discharge |
| Hamilton |
| Ontario |
| L8L 2X2 |
| Canada |
| Assam Medical College Hospital | Dt. Dibrugarh | Assam | 786002 | India |
| Lifeworth Super Specialty Hospital | Raipur | Chhattisgarh | 492001 | India |
| Post Graduate Institute of Medical | Rohtak | Haryana | 124001 | India |
| St. Johns Medical College | Bangalore | Karnataka | 560034 | India |
| Nanjappa Hospital | Shimoga | Karnataka | 577201 | India |
| Baby Memorial Hospital | Calicut | Kerala | 673004 | India |
| Caritas Hospital | Kottayam | Kerala | 686016 | India |
| KEM Hospital | Mumbai | Maharashtra | 400012 | India |
| MGIMS | Wardha | Maharashtra | 442102 | India |
| Railway Hospital | Chennai | Tamil Nadu | 600023 | India |
| Avanti Institute of Cardiology | Nagpur | 440012 | India |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D002318 | Cardiovascular Diseases |
| D009203 | Myocardial Infarction |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D006946 | Hyperinsulinism |
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| ID | Term |
|---|---|
| C479079 | insulin glulisine |
| D000069036 | Insulin Glargine |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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