Intravenous Insulin in Patients With Diabetes After Percutaneous Coronary Intervention (PCI)

Not Applicable

Terminated

• Conditions: Diabetes Mellitus; Percutaneous Coronary Intervention
• Interventions: Drug: Intravenous Insulin

• Registration Number: NCT00967642
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

Brief Summary

The purpose of this study is to evaluate the effects of intravenous insulin/24 hours to normalize glycemia upon markers of oxidative stress (protein oxidation and total antioxidant defense) and inflammation (C-reactive protein (CRP) and sCD40L) in diabetic patients submitted to PCI with stent.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08
• Primary Completion: 2008-07
• Study Completion: 2009-04
• Status Verified: 2009-08
• Study First Submitted: 2009-08-27
• Study First Submitted QC: 2009-08-27
• Last Update Submitted: 2009-08-27
• Study First Posted: 2009-08-28
• Last Update Posted: 2009-08-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Patients with Diabetes Mellitus submitted to Percutaneous Coronary Intervention with Stent bare metal
• Age: 18-80 years old

Exclusion Criteria

• Restenosis
• Drug elution stent
• Acute coronary syndrome at last 30 days
• Use anti inflammatory, antibiotic, vitamin E
• Inflammatory disease or oncologic

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intravenous Insulin	Intravenous Insulin	intravenous insulin/24h guided by glycemia (Optium, Abbott) evaluated hourly, targeting values lower than 110 mg/dl

Primary Outcome Measures

Name	Time	Method
Reintervention, Myocardial Infarction, Cardiovascular Death	6 months