Progenitor Cells Role in Restenosis and Atherosclerosis

Coronary Artery Disease Clinical Trial

— PROCREATION  

Official title:

PROgenitor Cells Role in Restenosis and Progression of Coronary ATherosclerosis After Percutaneous Coronary Intervention (PROCREATION) Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01575431
• Other study ID #: 199/2012/D
• Status: Completed
• Start date: April 2012
• Est. completion date: April 2020

Study information

• Verified date: April 2020
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: April 2020
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
Italy	University La Sapienza	Rome

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Results of the 1-year follow-up coronary angiography	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.	Up to 1 year
Secondary	Results of the 5-year clinical follow-up	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.	Up to 5 years
Secondary	Results of the 10-year clinical follow-up	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.	Up to 10 years