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

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.
ClinicalTrials.gov Identifier: NCT00362778
Recruitment Status : Completed
First Posted : August 10, 2006
Last Update Posted : March 20, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Hyperglycemia Acute Myocardial Infarction Drug: Insulin Phase 4

Detailed Description:
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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intensive Insulin Therapy in Non-diabetic Patients With Acute Myocardial Infarction and Hyperglycaemia
Study Start Date : January 2006
Primary Completion Date : December 2006
Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Sham Comparator: Serum saline Drug: Insulin
intravenous continuous insulin infusion for 48 hours


Outcome Measures

Primary Outcome Measures :
  1. Glycemic control [ Time Frame: first 48 hours ]

Secondary Outcome Measures :
  1. High-sensitivity C-reactive protein levels [ Time Frame: At 48 hours and aat hospital discharge ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00362778


Sponsors and Collaborators
Hospital Clinic of Barcelona
Investigators
Principal Investigator: Xavier Bosch Cardiology Department. Hospital Clínic i Universitari Barcelona
More Information

Responsible Party: Xavier Bosch, Dr, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT00362778     History of Changes
Other Study ID Numbers: The INSUCOR study
First Posted: August 10, 2006    Key Record Dates
Last Update Posted: March 20, 2012
Last Verified: March 2012

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Hyperglycemia
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs