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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
500
IV infusion of glulisine, SC injection of glargine
Instituto Medico Adrogue
Adrogué, Buenos Aires, Argentina
Hamilton Health Sciences, General Site
Hamilton, Ontario, Canada
Assam Medical College Hospital
Dt. Dibrugarh, Assam, India
The 24-hour difference in mean glucose between the two study groups.
Time frame: 24 hours
The difference in mean glucose level achieved at 7 days or hospital discharge (whichever is first)
Time frame: 7 days or discharge
The difference in mean glucose level achieved at 30 days between study groups
Time frame: 30 days
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
Rehospitalization for congestive heart failure
Time frame: Discharge, 30 days, 90 days, 1 year
All cause mortality
Time frame: Discharge, 30 days, 90 days, 1 year
Resuscitated cardiac arrest or life-threatening arrhythmia (as a composite and as separate outcomes)
Time frame: Discharge, 30 days, 90 days, 1 year
Cardiogenic shock
Time frame: Discharge, 30 days, 90 days, 1 year
Cardiac procedures
Time frame: Discharge, 30 days, 90 days, 1 year
Rehospitalization for any cause
Time frame: Discharge, 30 days, 90 days, 1 year
Symptomatic and severe hypoglycemic episodes
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Lifeworth Super Specialty Hospital
Raipur, Chhattisgarh, India
Post Graduate Institute of Medical
Rohtak, Haryana, India
St. Johns Medical College
Bangalore, Karnataka, India
Nanjappa Hospital
Shimoga, Karnataka, India
Baby Memorial Hospital
Calicut, Kerala, India
Caritas Hospital
Kottayam, Kerala, India
KEM Hospital
Mumbai, Maharashtra, India
...and 3 more locations
Time frame: Discharge, 30 days, 90 days, 1 year
Hypokalemic episodes
Time frame: Discharge