MedPath

Racial Disparities in Acute Stroke

Active, not recruiting
Conditions
Ischemic Stroke
Registration Number
NCT06955442
Lead Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
4500
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.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Racial/ethnic disparities in the access to revascularization treatmentsBaseline

Comparison of the likelihood of undergoing revascularization treatments among patients from different racial and/or ethnic groups.

Secondary Outcome Measures
NameTimeMethod
Racial/ethnic disparities in onset to door timesBaseline

Comparison of Onset-to-Door Time among patients from different racial and/or ethnic groups.

Racial/ethnic disparities in door to needle timesFrom the time of ED admission at baseline to start of intravenous thrombolysis

Comparison of differences in Door-to-Needle Time (DTN) between patients from different racial and/or ethnic groups.

Racial/ethnic disparities in door to groin timesFrom the time of ED admission at baseline to femoral puncture for mechanical thrombectomy

Comparison of differences in Door-to-Groin Time (DTG) between patients from different racial and/or ethnic groups.

Racial/ethnic differences in mode of emergency department arrivalBaseline

Comparison of ED arrival modes (walk-in vs emergency medical services) among patients from different racial and/or ethnic groups.

Racial/ethnic differences in the prevalence of cardiovascular risk factorsBaseline

Comparison of the prevalence of cerebrovascular risk factors among patients from different racial and/or ethnic groups.

Racial/ethnic differences in onset symptoms of strokeBaseline

Comparison of stroke clinical presentation patterns among patients from different racial and/or ethnic groups.

Racial/ethnic differences in stroke pathogenesisFrom enrollment to hospital discharge, up to 90-days from baseline

Comparison of stroke etiologies, classified according to the Trial of Org 10172 in Acute Stroke Treatment (TOAST) criteria, among patients from different racial and/or ethnic groups.

Racial/ethnic differences stroke outcome at dischargeFrom enrollment to hospital discharge, up to 90-days from baseline

Comparison of discharge modified Rankin Scale (mRS) scores among patients from different racial and/or ethnic groups.

Racial/ethnic differences in 3-month stroke outcomeFrom enrollment to the 3-month follow-up visit

Comparison of 3-month modified Rankin Scale (mRS) scores after acute ischemic stroke among patients from different racial and/or ethnic groups.

Trial Locations

Locations (15)

Ospedale Maggiore, IRCCS Istituto delle Scienze Neurologiche di Bologna - UO Neurologia OM e Rete Stroke Metropolitana (SC)

🇮🇹

Bologna, Italy

UOS Neurologia-AOU, IRCCS Istituto delle scienze Neurologiche

🇮🇹

Bologna, Italy

UOC Neurologia, ASST Crema

🇮🇹

Crema, Italy

UOC Neurologia - Ospedale Spaziani

🇮🇹

Frosinone, Italy

IRCCS Ospedale Policlinico San Martino

🇮🇹

Genova, Italy

Ospedale Vito Fazzi

🇮🇹

Lecce, Italy

Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli

🇮🇹

Naples, Italy

Fondazione IRCCS Policlinico San Matteo

🇮🇹

Pavia, Italy

IRCCS Fondazione Istituto Neurologico C. Mondino

🇮🇹

Pavia, Italy

IRCCS Istituto Neurologico Mediterraneo Neuromed

🇮🇹

Pozzilli, Italy

Policlinico Tor Vergata

🇮🇹

Roma, Italy

Policlinico Umberto I

🇮🇹

Rome, Italy

Fondazione Policlinico Universitario A. Gemelli IRCCS

🇮🇹

Rome, Italy

Humanitas Research Hospital IRCCS

🇮🇹

Rozzano, Italy

UOC Neurologia Belcolle - Ospedale Belcolle

🇮🇹

Viterbo, Italy

© Copyright 2025. All Rights Reserved by MedPath