Platelets Count Alterations in Patients With Acute Coronary Syndrome

NCT03583411 | Completed

• 1 other identifier: S_23_10_17_2001
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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 phase.1-3 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 antiaggregant/anticoagulant drugs (heparin, glycoprotein IIb/IIIa inhibitors, P2Y12 inhibitors). Even the invasive treatment of coronaropathy during hospitalization, with angioplasty and stent implantation procedures and/or the eventual implantation of temporary mechanical blood circulation assistant devices \[aortic counterpulsation, Impella, ECMO (Extracorporeal Membrane Oxygenation)\], could further favour the phenomenon.4 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.2 Different studies have demonstrated a significant correlation between platelets count disorders and patient outcome (survival during hospitalization and in the immediate follow-up).5-11 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 indexes.12 Those alterations, moreover, can usually influence changes to the therapeutic approach (reduction/suspension of recommended standard therapies) and further condition the prognosis.13 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 therapies.14 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.

Conditions

Acute Coronary Syndrome

Keywords

thrombocytopenia; thrombocytosis

Outcome Measures

Primary Outcomes (1)

• net adverse clinical events NACE

  the composite of a list of clinical events

  2014 to 2017

Secondary Outcomes (2)

• death

  2014 to 2017

• hospitalization

  2014 to 2017

Study Arms (1)

acute coronary syndrome (ACS) patients

ACS subjects hospitalized in the Cardiology 1 - UTIC department of ASST Grande Ospedale Metropolitano Niguarda between 2014 and 2017

Other: Epidemiological data collection

Interventions

Epidemiological data collection OTHER

To profile each subject enrolled in the study, anamnesis and different personal, clinical, procedural, pharmacological and follow up related variables will be collected. Data collection, maintenance and analysis will be performed using a database that will be developed, managed and updated by study promoter, in accordance with Good Clinical Practice (GCP)

acute coronary syndrome (ACS) patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with Acute Coronary Syndrome diagnosis

You may qualify if:

• All consecutive ACS subjects hospitalized in the Cardiology 1 - UTIC department of ASST Grande Ospedale Metropolitano Niguarda between 2014 and 2017

You may not qualify if:

• Age \<18 years
• Subjects admitted with ACS diagnosis but not confirmed at discharge

Sponsors & Collaborators

• Niguarda Hospital: lead

Study Sites (1)

Azienda Opsedaliera Ospedale Niguarda Ca' Granda

Milan, MI, 20162, Italy

Location

Related Publications (1)

• Morici N, Tavecchia GA, Antolini L, Caporale MR, Cantoni S, Bertuccio P, Sacco A, Meani P, Viola G, Brunelli D, Oliva F, Lombardi F, Segreto A, Oreglia JA, La Vecchia C, Cattaneo M, Valgimigli M, Savonitto S. Use of PRECISE-DAPT Score and Admission Platelet Count to Predict Mortality Risk in Patients With Acute Coronary Syndrome. Angiology. 2019 Oct;70(9):867-877. doi: 10.1177/0003319719848547. Epub 2019 May 14.

  PMID: 31088127 BACKGROUND

MeSH Terms

Conditions

Acute Coronary Syndrome; Thrombocytopenia; Thrombocytosis

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia; Myeloproliferative Disorders; Bone Marrow Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2018
• First Posted: July 11, 2018
• Study Start: June 25, 2018
• Primary Completion: February 28, 2019
• Study Completion: May 17, 2019
• Last Updated: May 21, 2019

Record last verified: 2019-05

Locations

IT (1)