Pilot Study Targeting Normal Glucose in Patients with Acute Myocardial Infarction through appropriate use of insulin therapy.

Phase 3

Completed

• Conditions: Health Condition 1: E086- Diabetes mellitus due to underlying condition with other specified complications

• Registration Number: CTRI/2008/091/000191
• Lead Sponsor: Aventis Pharma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 500

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified