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- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Rome, Italie, 00166
- University La Sapienza
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Results of the 1-year follow-up coronary angiography
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Results of the 5-year clinical follow-up
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Francesco Pelliccia, MD, University La Sapienza
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 199/2012/D
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