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

Cardiovascular Diseases Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00640991
• Other study ID #: RECREATE Pilot
• Status: Completed
• Phase: Phase 3
• First received: March 18, 2008
• Last updated: June 15, 2010
• Start date: April 2008
• Est. completion date: June 2010

Study information

• Verified date: June 2009
• Source: Population Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaIndia: Drugs Controller General of IndiaIndia: Central Drugs Standard Control OrganizationArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaArgentina: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Hyperglycemia
• Infarction
• Myocardial Infarction

Intervention

Drug:
• glulisine insulin, glargine insulin
IV infusion of glulisine, SC injection of glargine

Locations

Country	Name	City	State
Argentina	Instituto Medico Adrogue	Adrogue,	Buenos Aires
Canada	Hamilton Health Sciences, General Site	Hamilton	Ontario
India	St. Johns Medical College	Bangalore	Karnataka
India	Baby Memorial Hospital	Calicut	Kerala
India	Railway Hospital	Chennai	Tamilnadu
India	Assam Medical College Hospital	Dt. Dibrugarh	Assam
India	Caritas Hospital	Kottayam	Kerala
India	KEM Hospital	Mumbai	Maharashtra
India	Avanti Institute of Cardiology	Nagpur
India	Lifeworth Super Specialty Hospital	Raipur	Chattisgarh
India	Post Graduate Institute of Medical	Rohtak	Haryana
India	Nanjappa Hospital	Shimoga	Karnataka
India	MGIMS	Wardha	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Population Health Research Institute

Countries where clinical trial is conducted

Argentina,  Canada,  India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The 24-hour difference in mean glucose between the two study groups.		24 hours	No
Secondary	The difference in mean glucose level achieved at 7 days or hospital discharge (whichever is first)		7 days or discharge	No
Secondary	The difference in mean glucose level achieved at 30 days between study groups		30 days	No
Secondary	Nonfatal recurrent myocardial infarction, nonfatal stroke, or cardiovascular death (as a composite and as separate outcomes)		Discharge, 30 days, 90 days, 1 year	No
Secondary	Rehospitalization for congestive heart failure		Discharge, 30 days, 90 days, 1 year	No
Secondary	All cause mortality		Discharge, 30 days, 90 days, 1 year	No
Secondary	Resuscitated cardiac arrest or life-threatening arrhythmia (as a composite and as separate outcomes)		Discharge, 30 days, 90 days, 1 year	No
Secondary	Cardiogenic shock		Discharge, 30 days, 90 days, 1 year	No
Secondary	Cardiac procedures		Discharge, 30 days, 90 days, 1 year	No
Secondary	Rehospitalization for any cause		Discharge, 30 days, 90 days, 1 year	No
Secondary	Symptomatic and severe hypoglycemic episodes		Discharge, 30 days, 90 days, 1 year	Yes
Secondary	Hypokalemic episodes		Discharge	Yes