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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Page 1 of 3 (11 locations)

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