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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00362778
First Posted: August 10, 2006
Last Update Posted: March 20, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Xavier Bosch, Hospital Clinic of Barcelona
August 8, 2006
August 10, 2006
March 20, 2012
January 2006
December 2006   (Final data collection date for primary outcome measure)
Glycemic control [ Time Frame: first 48 hours ]
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 ]
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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
Intervention Model: Parallel Assignment
Masking: None (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
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*   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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
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NCT00362778
The INSUCOR study
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Xavier Bosch, Hospital Clinic of Barcelona
Hospital Clinic of Barcelona
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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