Ischemic StrokeVESPERALSNCT07230925
Study of the Rate of Progression of Cerebral Ischemia in Afro-Caribbeans
An observational study of Ischemic Stroke and Cerebral Ischemia, run by Centre Hospitalier Universitaire de la Guadeloupe at 1 site in Guadeloupe.
Trial summary
To compare the progression of cerebral ischemia from HF in Afro-Caribbean patients admitted to the CHUG to that of patients from Nantes included in the national ETIS registry. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke, Cerebral Ischemia, Endovascular Treatments
- How many people
- 135 participants
- Where
- 1 siteGuadeloupe
- Study dates
- Jan 2026to Jan 2028
- 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 with a diagnosis of stroke from LVO identified by medical imaging
Who may be able to join
- Patients aged 18 and over, admitted for IC due to LVO verified by medical imaging and hospitalized in neurology.
- Patients residing in Guadeloupe
- Afro-Caribbean patients: of African ancestry.
- Emergency inclusion, with exemption from obtaining consent due to the immediate life-threatening emergency situation of the patient (Article L1122-1-3 of the French Public Health Code); as soon as possible, consent to continue will be sought from the patient or, if applicable, from a relative or a trusted person.
- Patients affiliated to a social security scheme or equivalent
Who cannot join
- Patients under 18 years old
- Non-resident patients in Guadeloupe
- Protected persons (articles L1121-5, L1121-6 and L121-8 of the Public Health Code): pregnant or breastfeeding women, persons deprived of their liberty, under guardianship or curatorship)
- Withdrawal of consent during the study
- Patients not affiliated to a social security or equivalent scheme
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Eunice NUBRET contact
Guadeloupe1 site
Centre Hospitalier Universitaire de la Guadeloupe
Pointe-à-Pitre, Guadeloupe, 97159
Eunice NUBRET, +590590934686, eunice.nubret@chu-guadeloupe.fr
eunice.nubret@chu-guadeloupe.fr
About this study
To compare the progression of cerebral ischemia from HF in Afro-Caribbean patients admitted to the CHUG to that of patients from Nantes included in the national ETIS registry.
Read the detailed description
mpare the progression of cerebral ischemia of IC in Afro-Caribbean patients admitted to the CHUG with that of patients from Nantes included in the national register ETIS.
Secondary outcomes: Stroke is a sudden interruption of blood flow in the brain. Among the types of stroke, cerebral infarction is the most common (80% of cases). Cerebral infarction (CI) is a sudden disruption of brain circulation due to the occlusion of an artery by a clot. Large vessel occlusions (OLV) of the brain represent 30-40% of occlusions and are frequently associated with poor prognosis. Mechanical thrombectomy (MT) involves the extraction of the intra-arterial thrombus. Often performed in conjunction with intravenous thrombolysis (TIV), it has become the preferred treatment for OLV. However, not all patients with OLV are eligible for TM. It is recognized that for the same occlusion site, the rate of progression of HF varies from individual to individual. There are two categories of patients: the "fast progressor" and the "slow progressor". Patients referred to as "fast progressor" have a higher volume CI than "slow progressors" for the same time delay between onset of symptoms and imaging. The "fast progressor" profile is usually associated with an unfavourable functional prognosis. In the study by Rocha et al (ref. n°8), assessing the prevalence and distribution of ischemic volume progression rate in patients with OLV; 58% of patients had ischemic volume 30 mL and 72% had ischemic volume 70 mL within 24 hours after the onset of stroke. These patients were characterized as "slow progressors".
In 2022, a retrospective preliminary study was carried out at the Guadeloupe University Hospital and allowed for a comparison of patients treated within the institution with those of patients from the ETIS Register recording thrombectomies performed nationally. The comparison between the two populations shows that patients who have suffered a stroke in Guadeloupe are of type "fast progressor".
We hypothesize that the Afro-Caribbean patients admitted to CHUG for IC would be mostly "fast progressors".
The rate of progression will be determined using brain imaging from the measurement of ischemia volume. This faster progression could be explained by several factors including (1) differences in blood supply between the two populations; (2) environmental and climatic conditions and (3) epigenetic and genetic factors
- Conditions
- Ischemic Stroke, Cerebral Ischemia, Endovascular Treatments
- Being tested
- No Interventions
- Keywords
- Cerebrovascular accident, Cerebral Blood Flow
- Medical subject headings
- Ischemic Stroke, Brain Ischemia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionsOther
No interventions
| Study group | Role | What they receive |
|---|---|---|
| Patients residing in Guadeloupe | Patients residing in Guadeloupe Receives: Other: No Interventions | |
| Patients residing in Nantes | Patients residing in Nantes Receives: Other: No Interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression of cerebral ischemia of IC in Afro-Caribbean patients admitted to the CHUG with that of patients from Nantes included in the national register ETIS
Compare the progression of cerebral ischemia of IC in Afro-Caribbean patients admitted to the CHUG with that of patients from Nantes included in the national register ETIS
Measured: baseline, day 1,2,3,4 an day 90
Secondary outcomes (3)
Characterizing the profile of Afro-Caribbean patients
- the collateral imaging substitutions in patients of CHUG and CHU de Nantes. The collateral network will be evaluated either by perfusion imaging (Tmax > 6s) or by digitized arterial angiography in a thrombectomy room on the day of stroke according to the ASITN/SIR classification (J0).
Measured: baseline
Characterizing the profile of Afro-Caribbean patients
impact of environmental conditions on ischemia progression rate at Guadeloupe Hospital
Measured: baseline
Characterizing the profile of Afro-Caribbean
the effect of ischemia-reperfusion induced inflammatory response on ischemia volume
Measured: at the end of the suty
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study startJan 2026 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Guadeloupe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Donald ACCROMBESSI, Doctor, Principal investigator, CHU de la GuadeloupeValérie BASSIEN CASPA, PHD, Study chair, CHU de la Guadeloupe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07230925
- Sponsor's protocol ID
- PAP_RIPH2_2025/03
- Acronym
- VESPERALS
- Status last verified
- Oct 2025
- First submitted
- 14 Nov 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Rate of Progression of Cerebral Ischemia in Afro-Caribbeans
- ClinicalTrials.gov ID
- NCT07230925
- Acronym / sponsor ID
- VESPERALS / PAP_RIPH2_2025/03
- Conditions
- Ischemic Stroke, Cerebral Ischemia, Endovascular Treatments
- Keywords
- Cerebrovascular accident, Cerebral Blood Flow
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de la GuadeloupeUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 17 Nov 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.
To compare the progression of cerebral ischemia from HF in Afro-Caribbean patients admitted to the CHUG to that of patients from Nantes included in the national ETIS registry.
Detailed description
mpare the progression of cerebral ischemia of IC in Afro-Caribbean patients admitted to the CHUG with that of patients from Nantes included in the national register ETIS.
Secondary outcomes: Stroke is a sudden interruption of blood flow in the brain. Among the types of stroke, cerebral infarction is the most common (80% of cases). Cerebral infarction (CI) is a sudden disruption of brain circulation due to the occlusion of an artery by a clot. Large vessel occlusions (OLV) of the brain represent 30-40% of occlusions and are frequently associated with poor prognosis. Mechanical thrombectomy (MT) involves the extraction of the intra-arterial thrombus. Often performed in conjunction with intravenous thrombolysis (TIV), it has become the preferred treatment for OLV. However, not all patients with OLV are eligible for TM. It is recognized that for the same occlusion site, the rate of progression of HF varies from individual to individual. There are two categories of patients: the "fast progressor" and the "slow progressor". Patients referred to as "fast progressor" have a higher volume CI than "slow progressors" for the same time delay between onset of symptoms and imaging. The "fast progressor" profile is usually associated with an unfavourable functional prognosis. In the study by Rocha et al (ref. n°8), assessing the prevalence and distribution of ischemic volume progression rate in patients with OLV; 58% of patients had ischemic volume 30 mL and 72% had ischemic volume 70 mL within 24 hours after the onset of stroke. These patients were characterized as "slow progressors".
In 2022, a retrospective preliminary study was carried out at the Guadeloupe University Hospital and allowed for a comparison of patients treated within the institution with those of patients from the ETIS Register recording thrombectomies performed nationally. The comparison between the two populations shows that patients who have suffered a stroke in Guadeloupe are of type "fast progressor".
We hypothesize that the Afro-Caribbean patients admitted to CHUG for IC would be mostly "fast progressors".
The rate of progression will be determined using brain imaging from the measurement of ischemia volume. This faster progression could be explained by several factors including (1) differences in blood supply between the two populations; (2) environmental and climatic conditions and (3) epigenetic and genetic factors
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients residing in Guadeloupe | – | Other: No InterventionsPatients residing in Guadeloupe |
| Patients residing in Nantes | – | Other: No InterventionsPatients residing in Nantes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with a diagnosis of stroke from LVO identified by medical imaging
Key inclusion criteria (5 listed)
Key exclusion criteria (5 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionsNo interventions | Other | Patients residing in Guadeloupe, Patients residing in Nantes |
Primary outcome
progression of cerebral ischemia of IC in Afro-Caribbean patients admitted to the CHUG with that of patients from Nantes included in the national register ETIS
Time frame: baseline, day 1,2,3,4 an day 90
Compare the progression of cerebral ischemia of IC in Afro-Caribbean patients admitted to the CHUG with that of patients from Nantes included in the national register ETIS
3 secondary outcomes
Characterizing the profile of Afro-Caribbean patients
Time frame: baseline
Characterizing the profile of Afro-Caribbean patients
Time frame: baseline
Characterizing the profile of Afro-Caribbean
Time frame: at the end of the suty
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 17 Nov 2025.
- 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.
Eunice NUBRET contact
Donald ACCROMBESSI, Doctor principal investigator
CHU de la Guadeloupe
Valérie BASSIEN CASPA, PHD study chair
CHU de la Guadeloupe
1 site 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 and Cerebral Ischemia, run by Centre Hospitalier Universitaire de la Guadeloupe at 1 site in Guadeloupe.
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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Guadeloupe. 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?
Contact Valérie HAMONY-SOTER (+590590934686, valerie.soter@chu-guadeloupe.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression of cerebral ischemia of IC in Afro-Caribbean patients admitted to the CHUG with that of patients from Nantes included in the national register ETIS (time frame: baseline, day 1,2,3,4 an day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Nov 2025.