Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-25 @ 9:11 PM
Study NCT ID:
NCT01952756
Status:
COMPLETED
Last Update Posted:
2014-07-18
First Post:
2013-09-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Cilostazol Endothelial Progenitor Cells and Collateral Formation in Peripheral Occlusive Artery Disease (PAOD)
Sponsor:
National Cheng-Kung University Hospital
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2014-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: