Back to resultsREsearching Coronary REduction by Appropriately Targeting Euglycemia (RECREATE Pilot Study) (RECREATE Pilot)
Primary Purpose
Hyperglycemia, Cardiovascular Diseases, Myocardial Infarction
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
glulisine insulin, glargine insulin
Sponsored by
About this trial
This is an interventional treatment trial for Hyperglycemia focused on measuring Clinical Trial, Insulin
Eligibility 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
Sites / Locations
- Instituto Medico Adrogue
- Hamilton Health Sciences, General Site
- Assam Medical College Hospital
- Lifeworth Super Specialty Hospital
- Post Graduate Institute of Medical
- St. Johns Medical College
- Nanjappa Hospital
- Baby Memorial Hospital
- Caritas Hospital
- KEM Hospital
- MGIMS
- Railway Hospital
- Avanti Institute of Cardiology
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Intervention
Arm Description
Patients assigned to the control arm will receive usual care for AMI, according to local practice of each participating centre.
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.
Outcomes
Primary Outcome Measures
The 24-hour difference in mean glucose between the two study groups.
Secondary Outcome Measures
The difference in mean glucose level achieved at 7 days or hospital discharge (whichever is first)
The difference in mean glucose level achieved at 30 days between study groups
Nonfatal recurrent myocardial infarction, nonfatal stroke, or cardiovascular death (as a composite and as separate outcomes)
Rehospitalization for congestive heart failure
All cause mortality
Resuscitated cardiac arrest or life-threatening arrhythmia (as a composite and as separate outcomes)
Cardiogenic shock
Cardiac procedures
Rehospitalization for any cause
Symptomatic and severe hypoglycemic episodes
Hypokalemic episodes
Full Information
NCT ID
NCT00640991
First Posted
March 18, 2008
Last Updated
June 15, 2010
Sponsor
Population Health Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT00640991
Brief Title
REsearching Coronary REduction by Appropriately Targeting Euglycemia (RECREATE Pilot Study)
Acronym
RECREATE Pilot
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Population Health Research Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperglycemia, Cardiovascular Diseases, Myocardial Infarction
Keywords
Clinical Trial, Insulin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients assigned to the control arm will receive usual care for AMI, according to local practice of each participating centre.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
glulisine insulin, glargine insulin
Other Intervention Name(s)
Apidra, Lantus
Intervention Description
IV infusion of glulisine, SC injection of glargine
Primary Outcome Measure Information:
Title
The 24-hour difference in mean glucose between the two study groups.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
The difference in mean glucose level achieved at 7 days or hospital discharge (whichever is first)
Time Frame
7 days or discharge
Title
The difference in mean glucose level achieved at 30 days between study groups
Time Frame
30 days
Title
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
Title
Rehospitalization for congestive heart failure
Time Frame
Discharge, 30 days, 90 days, 1 year
Title
All cause mortality
Time Frame
Discharge, 30 days, 90 days, 1 year
Title
Resuscitated cardiac arrest or life-threatening arrhythmia (as a composite and as separate outcomes)
Time Frame
Discharge, 30 days, 90 days, 1 year
Title
Cardiogenic shock
Time Frame
Discharge, 30 days, 90 days, 1 year
Title
Cardiac procedures
Time Frame
Discharge, 30 days, 90 days, 1 year
Title
Rehospitalization for any cause
Time Frame
Discharge, 30 days, 90 days, 1 year
Title
Symptomatic and severe hypoglycemic episodes
Time Frame
Discharge, 30 days, 90 days, 1 year
Title
Hypokalemic episodes
Time Frame
Discharge
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hertzel Gerstein, MD, MSc, FRCPC
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Salim Yusuf, DPhil, FRCPC, FRSC
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Medico Adrogue
City
Adrogue,
State/Province
Buenos Aires
Country
Argentina
Facility Name
Hamilton Health Sciences, General Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
Facility Name
Assam Medical College Hospital
City
Dt. Dibrugarh
State/Province
Assam
ZIP/Postal Code
786002
Country
India
Facility Name
Lifeworth Super Specialty Hospital
City
Raipur
State/Province
Chattisgarh
ZIP/Postal Code
492001
Country
India
Facility Name
Post Graduate Institute of Medical
City
Rohtak
State/Province
Haryana
ZIP/Postal Code
124001
Country
India
Facility Name
St. Johns Medical College
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560034
Country
India
Facility Name
Nanjappa Hospital
City
Shimoga
State/Province
Karnataka
ZIP/Postal Code
577201
Country
India
Facility Name
Baby Memorial Hospital
City
Calicut
State/Province
Kerala
ZIP/Postal Code
673004
Country
India
Facility Name
Caritas Hospital
City
Kottayam
State/Province
Kerala
ZIP/Postal Code
686016
Country
India
Facility Name
KEM Hospital
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400012
Country
India
Facility Name
MGIMS
City
Wardha
State/Province
Maharashtra
ZIP/Postal Code
442102
Country
India
Facility Name
Railway Hospital
City
Chennai
State/Province
Tamilnadu
ZIP/Postal Code
600023
Country
India
Facility Name
Avanti Institute of Cardiology
City
Nagpur
ZIP/Postal Code
440012
Country
India
12. IPD Sharing Statement
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REsearching Coronary REduction by Appropriately Targeting Euglycemia (RECREATE Pilot Study)
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