Peripheral Arterial Diseases Clinical Trial
Official title:
Cilostazol Enhances the Number and Functions of Circulating Endothelial Progenitor Cells and Collateral Formation Assessed by Dual-energy 128-row CT Angiography Mediated Through Multiple Mechanisms in Patients With Mild-to-moderate PAOD
1. The number and function of circulating endothelial progenitor cells (EPCs) are
inversely associated with coronary risk factors and atherosclerotic diseases such as
PAOD.
2. This double-blind, randomized, placebo-controlled trial to evaluate the effects of
cilostazol on human early EPCs and angiogenesis as well as the potential mechanisms of
action in patients with mild-to-moderate PAOD.
1. titration of drugs
1. run-in period: eligible subjects are screened and baseline blood samples are
obtained
2. study period: 12 weeks
- 24 subjects with cilostazol and 20 subjects with dummy placebo
- On the first day after the end of the study period, the follow-up data are
obtained by the same procedure
3. blood sampling and measurement of serum biomarkers
- obtained from peripheral veins in all study subjects at the run-in period and
the end of the treatment period of the study
- sent for isolation, cell culture, and assays of human EPCs
- also stored for enzyme-linked immunosorbent assay (Stromal cell derived
factor-alfa1, adiponectin, soluble thrombomodulin, vascular endothelial
growth factor)
2. assays of human EPCs
1. colony formation by EPCs
2. quantification of EPCs and apoptotic endothelial cells
3. chemotactic motility, proliferation/viability and apoptosis assays
3. collateral vessels formation and distal run-off assessed by dual-energy multi-slice
computed tomography angiography
4. echocardiographic examinations to evaluate left ventricular functions
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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