Ignite Creation Date:
2024-05-06 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 12:49 PM
Study NCT ID:
NCT03583411
Status:
COMPLETED
Last Update Posted:
2019-05-21
First Post:
2018-06-28
Brief Title:
Platelets Count Alterations in Patients With Acute Coronary Syndrome
Sponsor:
Niguarda Hospital
Organization:
Niguarda Hospital
Study Overview
Official Title:
Platelets Count Alterations in Patients With Acute Coronary Syndrome Epidemiology and Prognostic Role
Status:
COMPLETED
Status Verified Date:
2019-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Platelet count alterations thrombocytopenia and thrombocytosis are a common condition in patients hospitalised for acute coronary syndrome ACS both at disease onset and in the following recovery phase1-3 Different factors can explain this phenomenon Thrombocytopenia could be either due to neurohormonal activation and the inflammatory process following myocardial necrosis leading to increased macrophage activation with increased clearance of platelets or to an immuno-modulated mechanism caused by the administration of antiaggregantanticoagulant drugs heparin glycoprotein IIbIIIa inhibitors P2Y12 inhibitors
Even the invasive treatment of coronaropathy during hospitalization with angioplasty and stent implantation procedures andor the eventual implantation of temporary mechanical blood circulation assistant devices aortic counterpulsation Impella ECMO Extracorporeal Membrane Oxygenation could further favour the phenomenon4 Vice versa thrombocytosis occurring during ACS has a reactive origin caused by increased IL-6 production which in turn leads to an increase in thrombopoietin formation in the liver causing a consequent stimulatory activity on megakaryocytes2 Different studies have demonstrated a significant correlation between platelets count disorders and patient outcome survival during hospitalization and in the immediate follow-up5-11 This association has however often been considered an epiphenomenon of the underlying pathology Platelets count alterations are indeed usually consensual to other hemogram alterations anaemia and neutropenia an indication of a coexisting medullar insufficiency thrombocytopenia or other heterogenous diseases such as cancer iron deficiency or immuno-modulated diseases usually associated with an increase in comorbidity indexes12 Those alterations moreover can usually influence changes to the therapeutic approach reductionsuspension of recommended standard therapies and further condition the prognosis13 Since a few years the investigators have been established a cardiac-haematological collaboration aiming at finding early alterations in platelets count or more generally in cell blood count CBC collegially evaluating those alterations with a cardiologist and a haematologist even in mild cases and scheduling on the basis of the aforementioned evaluations a more precise and tailored therapeutic approach toward the specific patient needs in order to minimize the downgrading of potentially life-saving therapies14 Until now however no precise evaluation of the impact that this strategy had in influencing the therapeutic approach and in improving patient outcome in our population has been performed
A retrospective evaluation of consecutive ACS patients their clinical biohumoral and procedural characteristics and the adopted pharmacological treatments is therefore an important epidemiologic tool for the characterization of this phenomenon and for identifying potential associations which could suggest possible future therapeutic developments
Even the invasive treatment of coronaropathy during hospitalization with angioplasty and stent implantation procedures andor the eventual implantation of temporary mechanical blood circulation assistant devices aortic counterpulsation Impella ECMO Extracorporeal Membrane Oxygenation could further favour the phenomenon4 Vice versa thrombocytosis occurring during ACS has a reactive origin caused by increased IL-6 production which in turn leads to an increase in thrombopoietin formation in the liver causing a consequent stimulatory activity on megakaryocytes2 Different studies have demonstrated a significant correlation between platelets count disorders and patient outcome survival during hospitalization and in the immediate follow-up5-11 This association has however often been considered an epiphenomenon of the underlying pathology Platelets count alterations are indeed usually consensual to other hemogram alterations anaemia and neutropenia an indication of a coexisting medullar insufficiency thrombocytopenia or other heterogenous diseases such as cancer iron deficiency or immuno-modulated diseases usually associated with an increase in comorbidity indexes12 Those alterations moreover can usually influence changes to the therapeutic approach reductionsuspension of recommended standard therapies and further condition the prognosis13 Since a few years the investigators have been established a cardiac-haematological collaboration aiming at finding early alterations in platelets count or more generally in cell blood count CBC collegially evaluating those alterations with a cardiologist and a haematologist even in mild cases and scheduling on the basis of the aforementioned evaluations a more precise and tailored therapeutic approach toward the specific patient needs in order to minimize the downgrading of potentially life-saving therapies14 Until now however no precise evaluation of the impact that this strategy had in influencing the therapeutic approach and in improving patient outcome in our population has been performed
A retrospective evaluation of consecutive ACS patients their clinical biohumoral and procedural characteristics and the adopted pharmacological treatments is therefore an important epidemiologic tool for the characterization of this phenomenon and for identifying potential associations which could suggest possible future therapeutic developments
Detailed Description:
Even the invasive treatment of coronaropathy during hospitalization with angioplasty and stent implantation procedures andor the eventual implantation of temporary mechanical blood circulation assistant devices aortic counterpulsation Impella ECMO Extracorporeal Membrane Oxygenation could further favour the phenomenon Vice versa thrombocytosis occurring during ACS has a reactive origin caused by increased IL-6 production which in turn leads to an increase in thrombopoietin formation in the liver causing a consequent stimulatory activity on megakaryocytes Different studies have demonstrated a significant correlation between platelets count disorders and patient outcome survival during hospitalization and in the immediate follow-up This association has however often been considered an epiphenomenon of the underlying pathology Platelets count alterations are indeed usually consensual to other hemogram alterations anaemia and neutropenia an indication of a coexisting medullar insufficiency thrombocytopenia or other heterogenous diseases such as cancer iron deficiency or immuno-modulated diseases usually associated with an increase in comorbidity indexes Those alterations moreover can usually influence changes to the therapeutic approach reductionsuspension of recommended standard therapies and further condition the prognosis Since a few yearsthe investigators have been established a cardiac-haematological collaboration aiming at finding early alterations in platelets count or more generally in cell blood count CBC collegially evaluating those alterations with a cardiologist and a haematologist even in mild cases and scheduling on the basis of the aforementioned evaluations a more precise and tailored therapeutic approach toward the specific patient needs in order to minimize the downgrading of potentially life-saving therapies Until now however no precise evaluation of the impact that this strategy had in influencing the therapeutic approach and in improving patient outcome in our population has been performed
A retrospective evaluation of consecutive ACS patients their clinical biohumoral and procedural characteristics and the adopted pharmacological treatments is therefore an important epidemiologic tool for the characterization of this phenomenon and for identifying potential associations which could suggest possible future therapeutic developments
A retrospective evaluation of consecutive ACS patients their clinical biohumoral and procedural characteristics and the adopted pharmacological treatments is therefore an important epidemiologic tool for the characterization of this phenomenon and for identifying potential associations which could suggest possible future therapeutic developments
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None