Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-24 @ 11:25 PM
NCT ID:
NCT01952756
Brief Summary:
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.
Detailed Description:
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
Study:
NCT01952756
Study Brief:
Protocol Section:
NCT01952756