drugset / Trial / NCT00314379
Endothelial Function in a Sample Group of Patients From the ICARE Study
Phase 2/3
Completed
50 enrolled
Technion, Israel Institute of Technology
Clalit Health Services · collabRambam Health Care Campus · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Vitamin E | Other / unclassified | 400 iu | — |