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.
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
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 group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
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
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
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
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
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
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.
- First posted2 May 2025
- Study start3 Apr 2025
- Primary completion15 Oct 2026 (estimated)
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frisullo Giovanni, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Giovanni Frisullo, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Ethnic and Racial Disparities in Access to Acute Stroke Care in Italy: A Multicentric, Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06955442
- Acronym / sponsor ID
- ERDAS / 7467
- Conditions
- Ischemic Stroke
- Keywords
- Stroke, Ischemic Stroke, Health disparities, Equity in healthcare
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 4,500 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 3 Apr 2025 (actual)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 2 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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).
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Discharge diagnosis other than ischemic stroke;
- Refusal to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Racial/ethnic disparities in the access to revascularization treatments
Time frame: Baseline
Comparison of the likelihood of undergoing revascularization treatments among patients from different racial and/or ethnic groups.
9 secondary outcomes
Racial/ethnic disparities in onset to door times
Time frame: Baseline
Racial/ethnic disparities in door to needle times
Time frame: From the time of ED admission at baseline to start of intravenous thrombolysis
Racial/ethnic disparities in door to groin times
Time frame: From the time of ED admission at baseline to femoral puncture for mechanical thrombectomy
Racial/ethnic differences in mode of emergency department arrival
Time frame: Baseline
Racial/ethnic differences in the prevalence of cardiovascular risk factors
Time frame: Baseline
Racial/ethnic differences in onset symptoms of stroke
Time frame: Baseline
Racial/ethnic differences in stroke pathogenesis
Time frame: From enrollment to hospital discharge, up to 90-days from baseline
Racial/ethnic differences stroke outcome at discharge
Time frame: From enrollment to hospital discharge, up to 90-days from baseline
Racial/ethnic differences in 3-month stroke outcome
Time frame: From enrollment to the 3-month follow-up visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Background: PubMed 39270410Frisullo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giovanni Frisullo principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
15 sites in 1 country: see every site and its status.
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.