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Intensive Insulin Therapy in Non-diabetic Patients With Acute Myocardial Infarction and Hyperglycaemia (INSUCOR)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Xavier Bosch, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT00362778
First received: August 8, 2006
Last updated: March 19, 2012
Last verified: March 2012
History of Changes

August 8, 2006
March 19, 2012
January 2006
December 2006   (final data collection date for primary outcome measure)
Glycemic control [ Time Frame: first 48 hours ] [ Designated as safety issue: No ]
We hypothesized that insulin infusion in this population could safely confer appropriate control of hyperglycemia and might be related to a better pro-inflammatory profile measured by the levels of high-sensitivity C-reactive protein (HS-CRP).
Complete list of historical versions of study NCT00362778 on ClinicalTrials.gov Archive Site
High-sensitivity C-reactive protein levels [ Time Frame: At 48 hours and aat hospital discharge ] [ Designated as safety issue: No ]
Same as current
 
 
 
Intensive Insulin Therapy in Non-diabetic Patients With Acute Myocardial Infarction and Hyperglycaemia
Intensive Insulin Therapy in Non-diabetic Patients With Acute Myocardial Infarction and Hyperglycaemia

Hyperglycemia at admission has been associated with bad prognosis in patients with acute myocardial infarction (AMI). The clinical benefit of intensive treatment with insulin has been evaluated in diabetic patients admitted to intensive care units. The aim of our study was to assess the short-term effects and the safety of strict glycemic control in subjects with AMI and hyperglycemia without a previous history of diabetes.

Twenty-eight non-previously diabetic patients admitted with AMI and hyperglycemia were randomized to two treatment arms, administered during the first 48 hours: the intensive group (n=13) received intravenous insulin with target glycemia levels of 80-110mg/dL, while the conventional group (n=15) received subcutaneous insulin only when glycemia was ³ 160mg/dL. High-sensitivity C-reactive protein (HS-CRP) was determined at 48 hours and before discharge and an oral glucose tolerance test (OGTT) was performed at 1 month.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes
  • Hyperglycemia
  • Acute Myocardial Infarction
Drug: Insulin
intravenous continuous insulin infusion for 48 hours
Sham Comparator: Serum saline
Intervention: Drug: Insulin
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
June 2007
December 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Confirmed diagnosis of AMI, either with or without ST segment elevation
  2. Presence of high blood glucose at admission with no previously known diabetes mellitus (DM)

Exclusion Criteria:

  1. Age under 18 years old
  2. History of DM
  3. Presence of other cardiopathies (dilated cardiomyopathy, valvular or hypertrophic heart disease)
  4. Unstable AMI patients (haemodynamic instability or arrhythmic disorders)
  5. Platelet aggregation or coagulation disorders
  6. Severe conditions with an estimated short (under 1 year) life expectancy
  7. Participation in other trials
  8. Patient refusal to participate in the study
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00362778
The INSUCOR study
 
Xavier Bosch, Hospital Clinic of Barcelona
Hospital Clinic of Barcelona
 
Principal Investigator: Xavier Bosch Cardiology Department. Hospital Clínic i Universitari Barcelona
Hospital Clinic of Barcelona
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP