Progenitor Cells Role in Restenosis and Atherosclerosis (PROCREATION)

This study is currently recruiting participants.
Verified March 2013 by University of Roma La Sapienza
Sponsor:
Information provided by (Responsible Party):
Francesco Pelliccia, University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT01575431
First received: April 6, 2012
Last updated: March 6, 2013
Last verified: March 2013

April 6, 2012
March 6, 2013
April 2012
December 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01575431 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Progenitor Cells Role in Restenosis and Atherosclerosis
PROgenitor Cells Role in Restenosis and Progression of Coronary ATherosclerosis After Percutaneous Coronary Intervention (PROCREATION) Study

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.

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.

Observational
Time Perspective: Prospective
Not Provided
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Non-Probability Sample

consecutive patient sampling

Coronary Artery Disease
Not Provided
Stable angina
Patients who undergo an elective and successful single or multivessel percutaneous coronary intervention can be considered for the study.
Pelliccia F, Pasceri V, Rosano G, Pristipino C, Roncella A, Speciale G, Pannarale G, Schiariti M, Greco C, Gaudio C. Endothelial progenitor cells predict long-term prognosis in patients with stable angina treated with percutaneous coronary intervention: five-year follow-up of the PROCREATION study. Circ J. 2013;77(7):1728-35. Epub 2013 Apr 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
December 2017
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • evidence of complete revascularization of clinically important stenoses by PCI
  • willing to undergo 8-month control angiography.

Exclusion Criteria:

  • in-hospital death after PCI
  • myocardial infarction during follow-up to exclude potential subacute stent
  • unstable angina
  • any increase in creatine kinase-myocardial band, troponin I, myoglobin, or liver enzymes above upper normal limit before PCI
  • left ventricular ejection fraction<30%
  • renal failure with creatinine>2 mg/dl
  • treatment with statins at referral
Both
18 Years and older
No
Contact: Francesco Pelliccia, MD +39064997 ext 123 f.pelliccia@mclink.it
Italy
 
NCT01575431
199/2012/D
No
Francesco Pelliccia, University of Roma La Sapienza
University of Roma La Sapienza
Not Provided
Principal Investigator: Francesco Pelliccia, MD University La Sapienza
University of Roma La Sapienza
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP