Progenitor Cells Role in Restenosis and Atherosclerosis (PROCREATION)
The aim of this study is to prospectively investigate the relationship of circulating endothelial progenitor cells at time of percutaneous coronary intervention to the subsequent development of in-stent restenosis or progression of coronary atherosclerosis.
Coronary Artery Disease
|Study Design:||Time Perspective: Prospective|
|Official Title:||PROgenitor Cells Role in Restenosis and Progression of Coronary ATherosclerosis After Percutaneous Coronary Intervention (PROCREATION) Study|
- Results of the 1-year follow-up coronary angiography [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]On the basis of the results of the 1-year follow-up coronary angiography, it will be possible to group patients in those with in-stent restenosis and those with progression of coronary atherosclerosis. Thereafter, numbers of endothelial progenitor cells at time of percutaneous coronary intervention will be compared between the two groups.
- Results of the 5-year clinical follow-up [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]On the basis of the results of the 5-year clinical follow-up period, it will be possible to group patients in those with favorable outcome and those with a poor prognosis. Thereafter, numbers of endothelial progenitor cells at time of percutaneous coronary intervention will be compared between the two groups.
|Study Start Date:||April 2012|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Patients who undergo an elective and successful single or multivessel percutaneous coronary intervention can be considered for the study.
Research on stem cells has identified a population of bone marrow-derived cells, called circulating endothelial progenitor cells (EPCs), that incorporate into sites of neovascularization and are home to sites of endothelial denudation thus contributing to the maintenance of vascular homeostasis.
Although extensive work has been conducted to verify if EPCs impairment plays a key role in coronary atherogenesis, it is still matter of debate if the extension and severity of coronary artery disease are associated with reduced or increased numbers of EPCs, as it remains unclear if these cells exert favorable or unfavorable effects at sites of percutaneous coronary intervention (PCI). One should consider, however, that most previous investigations have been hampered by discordant definitions of EPCs and by different timing of EPCs sampling, thus determining much uncertainty on the role of EPCs in restenosis and atherosclerosis progression. Furthermore, development of de novo lesions and post-PCI restenosis, which are pathophysiologically dissimilar, have not been examined concomitantly and serially over time.
Accordingly, the aim of this study is to carry out the first prospective assessment of the significance of subpopulations of circulating EPCs in the subsequent occurrence of restenosis or progression of coronary atherosclerosis after PCI. To this end, a pool of EPCs subtypes that are suggested to play some role in atherosclerosis is measured in a homogenous population of candidates to PCI. At variance with previous work, counts of EPCs are obtained in baseline conditions before PCI in order to avoid the confounding effect that the procedure exerts on EPCs.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01575431
|Contact: Francesco Pelliccia, MD||+39064997 ext firstname.lastname@example.org|
|University La Sapienza||Recruiting|
|Rome, Italy, 00166|
|Contact: Francesco Pelliccia, MD +39064997 ext 123 email@example.com|
|Principal Investigator:||Francesco Pelliccia, MD||University La Sapienza|