AzTrials
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Ischemic StrokeERDASNCT06955442

Racial Disparities in Acute Stroke

An observational study of Ischemic Stroke, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 15 sites in Italy.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ischemic Stroke
How many people
4,500 participants
Where
15 sitesItaly
Study dates
3 Apr 2025to 15 Jan 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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).

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

Italy15 sites
  • Ospedale Maggiore, IRCCS Istituto delle Scienze Neurologiche di Bologna - UO Neurologia OM e Rete Stroke Metropolitana (SC)

    Bologna, 40124

  • UOS Neurologia-AOU, IRCCS Istituto delle scienze Neurologiche

    Bologna, 40124

  • UOC Neurologia, ASST Crema

    Crema, 26013

  • UOC Neurologia - Ospedale Spaziani

    Frosinone, 03100

  • IRCCS Ospedale Policlinico San Martino

    Genova, 16132

  • Ospedale Vito Fazzi

    Lecce, 73100

  • Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli

    Naples, 80131

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100

  • IRCCS Fondazione Istituto Neurologico C. Mondino

    Pavia, 27100

  • IRCCS Istituto Neurologico Mediterraneo Neuromed

    Pozzilli, 86077

  • Policlinico Tor Vergata

    Roma, 00133

  • Policlinico Umberto I

    Rome, 00161

  • Fondazione Policlinico Universitario A. Gemelli IRCCS

    Rome, 00168

  • Humanitas Research Hospital IRCCS

    Rozzano, 20089

  • UOC Neurologia Belcolle - Ospedale Belcolle

    Viterbo, 01100

Other trials in Italy

About this study

Official title: Analysis of Ethnic and Racial Disparities in Access to Acute Stroke Care in Italy: A Multicentric, Prospective Cohort Study

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.

Read more

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
Keywords
Stroke, Ischemic Stroke, Health disparities, Equity in healthcare
Medical subject headings
Ischemic Stroke, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06955442
Study groupRoleWhat they receive
Patients presenting to the ED for acute ischemic strokePatients will be divided into several subgroups based on their racial/ethnic belonging (Asian/Hispanic/Black/White/Others).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Racial/ethnic disparities in the access to revascularization treatments

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

    Measured: Baseline

Secondary outcomes (9)
  1. Racial/ethnic disparities in onset to door times

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

    Measured: Baseline

  2. Racial/ethnic disparities in door to needle times

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

    Measured: From the time of ED admission at baseline to start of intravenous thrombolysis

  3. Racial/ethnic disparities in door to groin times

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

    Measured: From the time of ED admission at baseline to femoral puncture for mechanical thrombectomy

  4. Racial/ethnic differences in mode of emergency department arrival

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

    Measured: Baseline

  5. Racial/ethnic differences in the prevalence of cardiovascular risk factors

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

    Measured: Baseline

  6. Racial/ethnic differences in onset symptoms of stroke

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

    Measured: Baseline

  7. Racial/ethnic differences in stroke pathogenesis

    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.

    Measured: From enrollment to hospital discharge, up to 90-days from baseline

  8. Racial/ethnic differences stroke outcome at discharge

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

    Measured: From enrollment to hospital discharge, up to 90-days from baseline

  9. Racial/ethnic differences in 3-month stroke outcome

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

    Measured: From enrollment to the 3-month follow-up visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 May 2025
  2. Study start3 Apr 2025
  3. Primary completion15 Oct 2026 (estimated)
  4. Study completion15 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
4,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06955442
Sponsor's protocol ID
7467
Acronym
ERDAS
Status last verified
Apr 2025
First submitted
16 Apr 2025
Last updated
2 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39270410

Questions about this trial

What is this clinical trial studying?

An observational study of Ischemic Stroke, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 15 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Racial/ethnic disparities in the access to revascularization treatments (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06955442, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2025.

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Racial Disparities in Acute Stroke (NCT06955442) | AzTrials