REsearching Coronary REduction by Appropriately Targeting Euglycemia (RECREATE Pilot Study)

Phase 3

Completed

• Conditions: Hyperglycemia; Cardiovascular Diseases; Myocardial Infarction
• Interventions: Drug: glulisine insulin, glargine insulin

• Registration Number: NCT00640991
• Lead Sponsor: Population Health Research Institute

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.

Study Timeline

• Study First Submitted: 2008-03-18
• Study First Submitted QC: 2008-03-18
• Study First Posted: 2008-03-21
• Study Start: 2008-04
• Status Verified: 2009-06
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Last Update Submitted: 2010-06-15
• Last Update Posted: 2010-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• 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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	glulisine insulin, glargine insulin	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.

Primary Outcome Measures

Name	Time	Method
The 24-hour difference in mean glucose between the two study groups.	24 hours

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (13)

Assam Medical College Hospital; 🇮🇳 Dt. Dibrugarh, Assam, India

Lifeworth Super Specialty Hospital; 🇮🇳 Raipur, Chattisgarh, India

Caritas Hospital; 🇮🇳 Kottayam, Kerala, India

MGIMS; 🇮🇳 Wardha, Maharashtra, India

Hamilton Health Sciences, General Site; 🇨🇦 Hamilton, Ontario, Canada

Post Graduate Institute of Medical; 🇮🇳 Rohtak, Haryana, India

Railway Hospital; 🇮🇳 Chennai, Tamilnadu, India

Instituto Medico Adrogue; 🇦🇷 Adrogue,, Buenos Aires, Argentina

Avanti Institute of Cardiology; 🇮🇳 Nagpur, India

Baby Memorial Hospital; 🇮🇳 Calicut, Kerala, India

St. Johns Medical College; 🇮🇳 Bangalore, Karnataka, India

Nanjappa Hospital; 🇮🇳 Shimoga, Karnataka, India

KEM Hospital; 🇮🇳 Mumbai, Maharashtra, India