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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
  Purpose
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 Intervention Phase
Diabetes Hyperglycemia Acute Myocardial Infarction Drug: Insulin Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Xavier Bosch, Hospital Clinic of Barcelona:

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

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

Enrollment: 28
Study Start Date: January 2006
Study Completion Date: June 2007
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Serum saline Drug: Insulin
intravenous continuous insulin infusion for 48 hours

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.
  Eligibility

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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 Submitted: August 8, 2006
First Posted: August 10, 2006
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


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