REsearching Coronary REduction by Appropriately Targeting Euglycemia (RECREATE Pilot Study) - Full Text View

Sponsored by:	Population Health Research Institute
Information provided by:	Population Health Research Institute
ClinicalTrials.gov Identifier:	NCT00640991

Purpose

Insulin will safely reduce glucose levels in patients with acute ST-elevation myocardial infarction and admission hyperglycemia.

Condition	Intervention	Phase
Hyperglycemia Cardiovascular Diseases Myocardial Infarction	Drug: glulisine insulin, glargine insulin	Phase III

MedlinePlus related topics: Heart Attack

Drug Information available for: Insulin Insulin glargine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment
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

Further study details as provided by Population Health Research Institute:

Primary Outcome Measures:

The 24-hour difference in mean glucose between the two study groups. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The difference in mean glucose level achieved at 7 days or hospital discharge (whichever is first) [ Time Frame: 7 days or discharge ] [ Designated as safety issue: No ]
The difference in mean glucose level achieved at 30 days between study groups [ Time Frame: 30 days ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Rehospitalization for congestive heart failure [ Time Frame: Discharge, 30 days, 90 days, 1 year ] [ Designated as safety issue: No ]
All cause mortality [ Time Frame: Discharge, 30 days, 90 days, 1 year ] [ Designated as safety issue: No ]
Resuscitated cardiac arrest or life-threatening arrhythmia (as a composite and as separate outcomes) [ Time Frame: Discharge, 30 days, 90 days, 1 year ] [ Designated as safety issue: No ]
Cardiogenic shock [ Time Frame: Discharge, 30 days, 90 days, 1 year ] [ Designated as safety issue: No ]
Cardiac procedures [ Time Frame: Discharge, 30 days, 90 days, 1 year ] [ Designated as safety issue: No ]
Rehospitalization for any cause [ Time Frame: Discharge, 30 days, 90 days, 1 year ] [ Designated as safety issue: No ]
Symptomatic and severe hypoglycemic episodes [ Time Frame: Discharge, 30 days, 90 days, 1 year ] [ Designated as safety issue: Yes ]
Hypokalemic episodes [ Time Frame: Discharge ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	500
Study Start Date:	April 2008
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.	Drug: glulisine insulin, glargine insulin IV infusion of glulisine, SC injection of glargine

Arms

Assigned Interventions

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.

Drug: glulisine insulin, glargine insulin

IV infusion of glulisine, SC injection of glargine

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

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00640991

Contacts

Contact: Laura Joldersma	905 527 4322 ext 44220	recreate@cardio.on.ca
Contact: Lisa MacRae	905 527 4322 ext 44405	recreate@cardio.on.ca

Locations

Canada, Ontario
Hamilton Health Sciences, General Site	Recruiting
Hamilton, Ontario, Canada, L8L 2X2
Principal Investigator: Shamir Mehta, M.D.

Sponsors and Collaborators

Population Health Research Institute

Investigators

Principal Investigator:	Hertzel Gerstein, MD, MSc, FRCPC	McMaster University
Principal Investigator:	Salim Yusuf, DPhil, FRCPC, FRSC	McMaster University

More Information

No publications provided

Responsible Party:	McMaster University ( Dr. Hertzel Gerstein, Professor of Medicine )
Study ID Numbers:	RECREATE Pilot
Study First Received:	March 18, 2008
Last Updated:	February 3, 2009
ClinicalTrials.gov Identifier:	NCT00640991 History of Changes
Health Authority:	Canada: Health Canada; India: Drugs Controller General of India; India: Central Drugs Standard Control Organization; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Argentina: Ministry of Health

Keywords provided by Population Health Research Institute:

Clinical Trial
Insulin

Study placed in the following topic categories:

Metabolic Diseases
Heart Diseases
Insulin glulisine
Myocardial Ischemia
Vascular Diseases
Ischemia
Insulin
Necrosis

Hypoglycemic Agents
Hyperglycemia
Glargine
Infarction
Glucose Metabolism Disorders
Myocardial Infarction
Metabolic Disorder

Additional relevant MeSH terms:

Metabolic Diseases
Heart Diseases
Myocardial Ischemia
Physiological Effects of Drugs
Vascular Diseases
Ischemia
Pharmacologic Actions
Insulin
Necrosis

Hypoglycemic Agents
Hyperglycemia
Pathologic Processes
Glargine
Cardiovascular Diseases
Infarction
Glucose Metabolism Disorders
Myocardial Infarction

ClinicalTrials.gov processed this record on May 06, 2009