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

Primary Purpose

Diabetes, Hyperglycemia, Acute Myocardial Infarction

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Insulin
Sponsored by
Hospital Clinic of Barcelona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Confirmed diagnosis of AMI, either with or without ST segment elevation Presence of high blood glucose at admission with no previously known diabetes mellitus (DM) Exclusion Criteria: Age under 18 years old History of DM Presence of other cardiopathies (dilated cardiomyopathy, valvular or hypertrophic heart disease) Unstable AMI patients (haemodynamic instability or arrhythmic disorders) Platelet aggregation or coagulation disorders Severe conditions with an estimated short (under 1 year) life expectancy Participation in other trials Patient refusal to participate in the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Sham Comparator

    Arm Label

    Serum saline

    Arm Description

    Outcomes

    Primary Outcome Measures

    Glycemic control

    Secondary Outcome Measures

    High-sensitivity C-reactive protein levels

    Full Information

    First Posted
    August 8, 2006
    Last Updated
    March 19, 2012
    Sponsor
    Hospital Clinic of Barcelona
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00362778
    Brief Title
    Intensive Insulin Therapy in Non-diabetic Patients With Acute Myocardial Infarction and Hyperglycaemia
    Acronym
    INSUCOR
    Official Title
    Intensive Insulin Therapy in Non-diabetic Patients With Acute Myocardial Infarction and Hyperglycaemia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2006 (undefined)
    Primary Completion Date
    December 2006 (Actual)
    Study Completion Date
    June 2007 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital Clinic of Barcelona

    4. Oversight

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes, Hyperglycemia, Acute Myocardial Infarction

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    28 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Serum saline
    Arm Type
    Sham Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Insulin
    Intervention Description
    intravenous continuous insulin infusion for 48 hours
    Primary Outcome Measure Information:
    Title
    Glycemic control
    Time Frame
    first 48 hours
    Secondary Outcome Measure Information:
    Title
    High-sensitivity C-reactive protein levels
    Time Frame
    At 48 hours and aat hospital discharge

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Confirmed diagnosis of AMI, either with or without ST segment elevation Presence of high blood glucose at admission with no previously known diabetes mellitus (DM) Exclusion Criteria: Age under 18 years old History of DM Presence of other cardiopathies (dilated cardiomyopathy, valvular or hypertrophic heart disease) Unstable AMI patients (haemodynamic instability or arrhythmic disorders) Platelet aggregation or coagulation disorders Severe conditions with an estimated short (under 1 year) life expectancy Participation in other trials Patient refusal to participate in the study
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Xavier Bosch
    Organizational Affiliation
    Cardiology Department. Hospital Clínic i Universitari Barcelona
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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