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

Phase 4

Completed

• Conditions: Diabetes; Hyperglycemia; Acute Myocardial Infarction
• Interventions: Drug: Insulin

• Registration Number: NCT00362778
• Lead Sponsor: Hospital Clinic of Barcelona

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.

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-08-08
• Study First Submitted QC: 2006-08-08
• Study First Posted: 2006-08-10
• Primary Completion: 2006-12
• Study Completion: 2007-06
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-19
• Last Update Posted: 2012-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Serum saline	Insulin	-

Primary Outcome Measures

Name	Time	Method
Glycemic control	first 48 hours

Secondary Outcome Measures

Name	Time	Method
High-sensitivity C-reactive protein levels	At 48 hours and aat hospital discharge