Study of the Rate of Progression of Cerebral Ischemia in Afro-Caribbeans (VESPERALS)

November 14, 2025 updated by: Centre Hospitalier Universitaire de la Guadeloupe
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

135

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients with a diagnosis of stroke from LVO identified by medical imaging

Description

  • inclusion criteria:

    • 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

  • exclusion criteria:

    • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients residing in Guadeloupe
Other: No Interventions
No interventions
Patients residing in Nantes
Other: No Interventions
No interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline, day 1,2,3,4 an day 90

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Characterizing the profile of Afro-Caribbean patients
Time Frame: baseline
1. 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).
baseline
Characterizing the profile of Afro-Caribbean patients
Time Frame: baseline
impact of environmental conditions on ischemia progression rate at Guadeloupe Hospital
baseline
Characterizing the profile of Afro-Caribbean
Time Frame: at the end of the suty
the effect of ischemia-reperfusion induced inflammatory response on ischemia volume
at the end of the suty

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de la Guadeloupe

Investigators

  • Principal Investigator: Donald ACCROMBESSI, Doctor, CHU de la Guadeloupe
  • Study Chair: Valérie BASSIEN CASPA, PHD, CHU de la Guadeloupe

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

November 14, 2025

First Submitted That Met QC Criteria

November 14, 2025

First Posted (Actual)

November 17, 2025

Study Record Updates

Last Update Posted (Actual)

November 17, 2025

Last Update Submitted That Met QC Criteria

November 14, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAP_RIPH2_2025/03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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