Status:
NOT_YET_RECRUITING
Genetic Variants in Stroke
Lead Sponsor:
Hospital Moinhos de Vento
Collaborating Sponsors:
Ministry of Health, Brazil
Conditions:
Stroke
Genetic Association Studies
Eligibility:
All Genders
18+ years
Brief Summary
Stroke is the leading cause of death and disability in Brazil and worldwide, with a significant socioeconomic impact. Despite advances in prevention and treatment, the role of genetic variants in isch...
Detailed Description
Study Overview: ÁRTEMIS-Brazil is a multicenter, case-control study that will recruit 1,000 participants (500 stroke patients and 500 controls) across 10 hospitals in Brazil. All participants will be ...
Eligibility Criteria
Inclusion
- Cases
- Age ≥18 years;
- Confirmed diagnosis by neuroimaging (CT or MRI) of a first episode of ischemic stroke in the last 12 months;
- TOAST classification of stroke available: cardioembolic, lacunar, atherosclerotic, or undetermined due to the presence of multiple sources (cardioembolic/atherosclerotic);
- Modified Rankin Scale (mRS) ≤4 at the time of inclusion;
- Ability and willingness to provide consent and participate in follow-up assessments.
- Controls
- Age ≥18 years;
- Reside in the same household or, if not, in the same neighborhood as the case group participant;
- Not be a blood relative of the case group participant;
- Ability and willingness to provide consent and participate in follow-up assessments.
Exclusion
- Cases
- Ischemic stroke with a distinct etiology based on TOAST criteria (e.g., infectious, autoimmune, endocarditis, reversible cerebral vasoconstriction syndrome, drug-related causes);
- Diagnosis of monogenic or mitochondrial disorders, such as CADASIL, Fabry disease, homocystinuria, MELAS, sickle cell disease, among others;
- Clinical conditions that reduce life expectancy to less than one year (e.g., neoplasia);
- Inability to undergo magnetic resonance imaging (due to metal artifacts, MRI-incompatible implants, claustrophobia);
- Other conditions that, at the investigator's discretion, prevent participation or compromise follow-up.
- Controls
- Personal history of stroke, transient ischemic attack (TIA), coronary, or peripheral artery disease;
- Serious comorbidities that may impact participation or confound the results;
- Clinical conditions that reduce life expectancy to less than one year;
- Inability to provide consent due to cognitive impairment or other factors;
- Inability to undergo magnetic resonance imaging (due to metal artifacts, incompatible implants, claustrophobia);
- Diagnosis of monogenic or mitochondrial disorders, such as CADASIL, Fabry disease, homocystinuria, MELAS, or sickle cell disease;
- Other conditions that, at the investigator's discretion, prevent participation or compromise follow-up.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2030
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT07186517
Start Date
October 1 2025
End Date
December 31 2030
Last Update
September 22 2025
Active Locations (11)
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1
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
2
Hospital Ophir Loyola
Belém, Brazil
3
Hospital Metropolitano Dr. Célio de Castro
Belo Horizonte, Brazil
4
Hospital Geral de Roraima
Boa Vista, Brazil