Clinical trial NCT06955442: Racial Disparities in Acute Stroke
Official title: Analysis of Ethnic and Racial Disparities in Access to Acute Stroke Care in Italy: A Multicentric, Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Ischemic Stroke
Keywords: Stroke
Ischemic Stroke
Health disparities
Equity in healthcare
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2025-05-02
Enrollment: 4500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting to the ED of a hospital for a suspected stroke diagnosis. Patients will be then divided into different subgroups according to their racial/ethnic belonging (White, Asian, Hispanic, Black, Others).

Brief summary: Ischemic stroke is one of the leading causes of mortality and disability worldwide. Although the prevalence of stroke is high globally, not all ethnic and racial groups are affected in the same way, leading to the classification of stroke as an inequitable disease.

First of all, ethnic and racial background influences the pathogenesis of stroke, as numerous risk factors-both modifiable and non-modifiable-are more prevalent in Black and Hispanic populations compared to Asian ones. As a direct consequence, the incidence of stroke is higher in Black and Hispanic individuals than in White individuals. Unfortunately, despite this, access to revascularization treatments is not always guaranteed for ethnic and racial minorities, although in recent years, this inequality in access to care appears to be decreasing.

Moreover, stroke prognosis also seems to differ based on race/ethnicity, with mortality being higher among Black individuals compared to White individuals, although this trend tends to decrease with advancing age. On the other hand, although cerebral hemorrhage is more prevalent in Black and Asian populations than in White populations, it tends to have a better prognosis in these minority groups.

It must be considered, however, that the vast majority of studies on this topic have been conducted in the United States, where the ethnic and racial composition of the population is very different from that of Italy and Europe. In these latter contexts, studies investigating the impact of race and/or ethnicity on the clinical characteristics, management, and prognosis of ischemic stroke are lacking. Furthermore, differences in healthcare system organization may play a significant role in limiting access to timely and appropriate medical care for acute stroke based on race and/or ethnicity.

Italy is a country where, similarly to other European nations, the last few decades have seen a significant increase in immigration rates, particularly from Eastern Europe. Today, foreigners account for approximately 9% of the total population. Nevertheless, in Italy, systemic racism toward ethnic and racial minorities remains a significant issue, as evidenced by large disparities in educational attainment, socioeconomic status, and housing conditions between Italian citizens and foreign residents.

Although the universal national healthcare system in Italy should ensure equal access to care and emergency treatment for all, regardless of ethnic and racial background, there are no studies investigating this topic. A recent scoping review highlighted how individual racism plays a primary role in generating health inequalities, whereas there is very limited evidence focused on the analysis of structural and institutional racism in the Italian and European context.

As a consequence, this study aims to prospectively investigate the presence and the extent of racial and ethnic disparities in access to stroke care and treatment across several Italian comprehensive stroke centers.


Eligibility criteria: Inclusion Criteria:

* Adults (≥18 years old);
* Admission to the Emergency Department of the participating center with a diagnosis of ischemic stroke, as defined by the International Classification of Diseases, 9th Revision (ICD-9) codes;
* Signed informed consent provided by the patient or, in cases of impaired decision-making capacity, by their legal guardian/representative.

Exclusion Criteria:

* Discharge diagnosis other than ischemic stroke;
* Refusal to participate in the study.

Primary outcomes:
measure: Racial/ethnic disparities in the access to revascularization treatments
timeFrame: Baseline
Secondary outcomes:
measure: Racial/ethnic disparities in onset to door times
timeFrame: Baseline
measure: Racial/ethnic disparities in door to needle times
timeFrame: From the time of ED admission at baseline to start of intravenous thrombolysis
measure: Racial/ethnic disparities in door to groin times
timeFrame: From the time of ED admission at baseline to femoral puncture for mechanical thrombectomy
measure: Racial/ethnic differences in mode of emergency department arrival
timeFrame: Baseline
measure: Racial/ethnic differences in the prevalence of cardiovascular risk factors
timeFrame: Baseline
measure: Racial/ethnic differences in onset symptoms of stroke
timeFrame: Baseline
measure: Racial/ethnic differences in stroke pathogenesis
timeFrame: From enrollment to hospital discharge, up to 90-days from baseline
measure: Racial/ethnic differences stroke outcome at discharge
timeFrame: From enrollment to hospital discharge, up to 90-days from baseline
measure: Racial/ethnic differences in 3-month stroke outcome
timeFrame: From enrollment to the 3-month follow-up visit
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Ospedale Maggiore, IRCCS Istituto delle Scienze Neurologiche di Bologna - UO Neurologia OM e Rete Stroke Metropolitana (SC)
city: Bologna
country: Italy
facility: UOS Neurologia-AOU, IRCCS Istituto delle scienze Neurologiche
city: Crema
country: Italy
facility: UOC Neurologia, ASST Crema
city: Frosinone
country: Italy
facility: UOC Neurologia - Ospedale Spaziani
city: Genova
country: Italy
facility: IRCCS Ospedale Policlinico San Martino
city: Lecce
country: Italy
facility: Ospedale Vito Fazzi
city: Naples
country: Italy
facility: Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
city: Pavia
country: Italy
facility: IRCCS Fondazione Istituto Neurologico C. Mondino
city: Pozzilli
country: Italy
facility: IRCCS Istituto Neurologico Mediterraneo Neuromed
city: Roma
country: Italy
facility: Policlinico Tor Vergata
city: Rome
country: Italy
facility: Policlinico Umberto I
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
city: Rozzano
country: Italy
facility: Humanitas Research Hospital IRCCS
city: Viterbo
country: Italy
facility: UOC Neurologia Belcolle - Ospedale Belcolle
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Giovanni Frisullo
role: PRINCIPAL_INVESTIGATOR
References:
citation: Frisullo G, Scala I, Di Giovanni J, Rizzo PA, Bellavia S, Broccolini A, Monforte M, Franceschi F, Gasbarrini A, Carbone L, Calabresi P, Covino M. Racial and ethnic differences in access to care and treatment in patients with suspected acute stroke: A retrospective, observational, cohort study. J Neurol Sci. 2024 Nov 15;466:123225. doi: 10.1016/j.jns.2024.123225. Epub 2024 Sep 10.