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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • Glycemic control [ Time Frame: first 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • High-sensitivity C-reactive protein levels [ Time Frame: At 48 hours and aat hospital discharge ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00362778

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

No publications provided

Responsible Party: Xavier Bosch, Dr, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT00362778     History of Changes
Other Study ID Numbers: The INSUCOR study
Study First Received: August 8, 2006
Last Updated: March 19, 2012
Health Authority: Spain: Comité Ético de Investigación Clínica

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

ClinicalTrials.gov processed this record on July 28, 2014