- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01575431
Progenitor Cells Role in Restenosis and Atherosclerosis (PROCREATION)
PROgenitor Cells Role in Restenosis and Progression of Coronary ATherosclerosis After Percutaneous Coronary Intervention (PROCREATION) Study
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Rome, Italia, 00166
- University La Sapienza
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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Stable angina
Patients who undergo an elective and successful single or multivessel percutaneous coronary intervention can be considered for the study.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Results of the 1-year follow-up coronary angiography
Tidsramme: Up to 1 year
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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.
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Up to 1 year
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Results of the 5-year clinical follow-up
Tidsramme: Up to 5 years
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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.
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Up to 5 years
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Results of the 10-year clinical follow-up
Tidsramme: Up to 10 years
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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.
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Up to 10 years
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Francesco Pelliccia, MD, University La Sapienza
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Pelliccia F, Pasceri V, Moretti A, Tanzilli G, Speciale G, Gaudio C. Endothelial progenitor cells predict long-term outcome in patients with coronary artery disease: Ten-year follow-up of the PROCREATION extended study. Int J Cardiol. 2020 Nov 1;318:123-125. doi: 10.1016/j.ijcard.2020.06.002. Epub 2020 Jun 6.
- 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. doi: 10.1253/circj.cj-12-1608. Epub 2013 Apr 11.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 199/2012/D
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