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Progenitor Cells Role in Restenosis and Atherosclerosis (PROCREATION)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2013 by Francesco Pelliccia, University of Roma La Sapienza.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01575431
First Posted: April 11, 2012
Last Update Posted: March 7, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Francesco Pelliccia, University of Roma La Sapienza
  Purpose
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.

Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: PROgenitor Cells Role in Restenosis and Progression of Coronary ATherosclerosis After Percutaneous Coronary Intervention (PROCREATION) Study

Resource links provided by NLM:


Further study details as provided by Francesco Pelliccia, University of Roma La Sapienza:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 200
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)
Groups/Cohorts
Stable angina
Patients who undergo an elective and successful single or multivessel percutaneous coronary intervention can be considered for the study.

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.

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
consecutive patient sampling
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01575431


Contacts
Contact: Francesco Pelliccia, MD +39064997 ext 123 f.pelliccia@mclink.it

Locations
Italy
University La Sapienza Recruiting
Rome, Italy, 00166
Contact: Francesco Pelliccia, MD    +39064997 ext 123    f.pelliccia@mclink.it   
Sponsors and Collaborators
University of Roma La Sapienza
Investigators
Principal Investigator: Francesco Pelliccia, MD University La Sapienza
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Francesco Pelliccia, Assistant Professor, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT01575431     History of Changes
Other Study ID Numbers: 199/2012/D
First Submitted: April 6, 2012
First Posted: April 11, 2012
Last Update Posted: March 7, 2013
Last Verified: March 2013

Keywords provided by Francesco Pelliccia, University of Roma La Sapienza:
coronary artery disease
endothelial progenitor cells

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Atherosclerosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases