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Not yet recruiting NCT07230925

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

Observational Ischemic Stroke Cerebral Ischemia Endovascular Treatments

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No Interventions.
Who it may be relevant to
Registry conditions: Ischemic Stroke, Cerebral Ischemia, Endovascular Treatments. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Guadeloupe
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

Interventions

  • Other No Interventions
    No interventions

Primary outcome measures

  • 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]
Secondary outcome measures (3)
  • 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]

Eligibility criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Guadeloupe · 1 center
  • Centre Hospitalier Universitaire de la Guadeloupe — Pointe-à-Pitre

Identifiers

NCT: NCT07230925 · PAP_RIPH2_2025/03

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗