Racial Disparities in Acute Stroke

NCT ID: NCT06955442

Last Updated: 2025-05-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 4500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-04-03
• Study Completion Date: 2027-01-15

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.

Conditions

Ischemic Stroke

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients presenting to the ED for acute ischemic stroke

Patients will be divided into several subgroups based on their racial/ethnic belonging (Asian/Hispanic/Black/White/Others).

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Frisullo Giovanni

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Giovanni Frisullo

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Locations

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

Countries

Italy

References

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.

Reference Type: BACKGROUND

PMID: 39270410 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

7467

Identifier Type: -

Identifier Source: org_study_id