drugset / Trial / NCT00314379

Endothelial Function in a Sample Group of Patients From the ICARE Study

NCT00314379

RandomizedParallel-groupDouble-blindPrevention

Summary

The ICARE study, clinicaltrials.gov ID number: NCT00220831 and protocol number KL-2004, is recruiting diabetic patients with haptoglobin phenotype 2-2, which are randomised to either Vitamin E 400IU per day or placebo. Patients will be followed for 4 years for the major cardiovascular complications of diabetes, acute myocardial infarction (MI), stroke and cardiovascular mortality (see ICARE protocol). The EFI study, Endothelial Function in ICARE will recruit a sample group of 50 patients from the ICARE cohort. These patients will complete all requirements by ICARE protocol and in addition will be tested for endothelial function by a non-invasive method of flow mediated dilatation (FMD).

Timeline

Start
2006-04
Primary completion
Completion
2007-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Vitamin E Other / unclassified 400 iu