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

Diabetes Clinical Trial

— INSUCOR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00362778
• Other study ID #: The INSUCOR study
• Status: Completed
• Phase: Phase 4
• First received: August 8, 2006
• Last updated: March 19, 2012
• Start date: January 2006
• Est. completion date: June 2007

Study information

• Verified date: March 2012
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 2007
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Diabetes
• Hyperglycemia
• Infarction
• Myocardial Infarction

Intervention

Drug:
• Insulin
intravenous continuous insulin infusion for 48 hours

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic control		first 48 hours	No
Secondary	High-sensitivity C-reactive protein levels		At 48 hours and aat hospital discharge	No