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Progenitor Cells Role in Restenosis and Atherosclerosis (PROCREATION)

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ClinicalTrials.gov Identifier: NCT01575431
Recruitment Status : Completed
First Posted : April 11, 2012
Last Update Posted : April 9, 2020
Sponsor:
Information provided by (Responsible Party):
Francesco Pelliccia, University of Roma La Sapienza

Tracking Information
First Submitted Date April 6, 2012
First Posted Date April 11, 2012
Last Update Posted Date April 9, 2020
Actual Study Start Date April 2012
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 9, 2012)
Results of the 1-year follow-up coronary angiography [ Time Frame: Up to 1 year ]
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 7, 2020)
  • Results of the 5-year clinical follow-up [ Time Frame: Up to 5 years ]
    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.
  • Results of the 10-year clinical follow-up [ Time Frame: Up to 10 years ]
    On the basis of the results of the 10-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.
Original Secondary Outcome Measures
 (submitted: April 9, 2012)
Results of the 5-year clinical follow-up [ Time Frame: Up to 5 years ]
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Progenitor Cells Role in Restenosis and Atherosclerosis
Official Title PROgenitor Cells Role in Restenosis and Progression of Coronary ATherosclerosis After Percutaneous Coronary Intervention (PROCREATION) Study
Brief 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.
Detailed 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 Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population consecutive patient sampling
Condition Coronary Artery Disease
Intervention Not Provided
Study Groups/Cohorts Stable angina
Patients who undergo an elective and successful single or multivessel percutaneous coronary intervention can be considered for the study.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 9, 2012)
200
Original Estimated Enrollment Same as current
Actual Study Completion Date April 2020
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT01575431
Other Study ID Numbers 199/2012/D
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Francesco Pelliccia, University of Roma La Sapienza
Study Sponsor University of Roma La Sapienza
Collaborators Not Provided
Investigators
Principal Investigator: Francesco Pelliccia, MD University La Sapienza
PRS Account University of Roma La Sapienza
Verification Date April 2020