Study of the Rate of Progression of Cerebral Ischemia in Afro-Caribbeans

NCT ID: NCT07230925

Last Updated: 2025-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

135 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-31

Study Completion Date

2028-01-31

Brief Summary

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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

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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

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Ischemic Stroke Cerebral Ischemia Endovascular Treatments

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients residing in Guadeloupe

Patients residing in Guadeloupe

No Interventions

Intervention Type OTHER

No interventions

Patients residing in Nantes

Patients residing in Nantes

No Interventions

Intervention Type OTHER

No interventions

Interventions

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No Interventions

No interventions

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de la Guadeloupe

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Donald ACCROMBESSI, Doctor

Role: PRINCIPAL_INVESTIGATOR

CHU de la Guadeloupe

Valérie BASSIEN CASPA, PHD

Role: STUDY_CHAIR

CHU de la Guadeloupe

Locations

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Centre Hospitalier Universitaire de la Guadeloupe

Pointe-à-Pitre, Guadeloupe, Guadeloupe

Site Status

Countries

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Guadeloupe

Central Contacts

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Valérie HAMONY-SOTER

Role: CONTACT

+590590934686

Eunice NUBRET

Role: CONTACT

Facility Contacts

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Eunice NUBRET

Role: primary

+590590934686

Role: backup

Other Identifiers

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PAP_RIPH2_2025/03

Identifier Type: -

Identifier Source: org_study_id

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