Progenitor Cells Role in Restenosis & Atherosclerosis

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01575431
Study type	Observational
Source	University of Roma La Sapienza
Contact
Status	Completed
Phase
Start date	April 2012
Completion date	April 2020

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Progenitor Cells Role in Restenosis and Atherosclerosis — PROCREATION

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms