Fangshan / Family-based Ischemic Stroke Study In China "FISSIC"

Recruiting

Phase N/A Results N/A

Trial Description

The exact etiology of ischemic stroke remains unclear, because multiple genetic predispositions and environmental risk factors may be involved, and their interactions dictate the complexity. Family-based studies provide unique features in design because of their robustness to population admixture and stratification. The Fangshan / Family-based Ischemic Stroke Study In China (FISSIC) program aims to conduct a genetic pedigree study of ischemic stroke in rural communities of China.

Detailed Description

The FISSIC program is a community-based and hospital-centered genetic epidemiological study of ischemic stroke. The study design has two components: first, a family-based study of ischemic stroke pedigrees, including probands, their siblings, and their parents; second, the traditional matched case-control study of ischemic stroke cases and their unaffected spouses. Cases with confirmed ischemic stroke are included as probands; after their informed consent is obtained, their parents, siblings, and unaffected spouses are recruited and screened by using the proband-initiated contact method. Stroke status is verified at the central hospital, and the index stroke for each case is subtyped by medical records. Baseline clinical and demographic data are collected by questionnaire, and longitudinal follow-up visits are scheduled. Blood samples are collected from all enrolled participants through the three-tier prevention and health care network (village, township and county level) in the study area. The samples are sent to the central laboratory for processing, testing, and genotyping. The genotype data are then merged with the clinical, environmental, and follow-up data for analysis. Comprehensive statistical methods are applied to both family-based and case-control data to ascertain potential complex genetic and environmental factors and their interactions.

Conditions

Trial Design

  • Observation: Family-Based
  • Perspective: Cross-Sectional
  • Sampling: Non-Probability Sample

Trial Population

Ischemic stroke probands will be enrolled in two parts: incident cases from primary care clinic and prevalent cases from communities, and their family members will be recuited in communities.

Patient Involvement

Patients with suspected ischemic stroke entering the hospital will be invited to participate (probands), and those agreeing to do so will then invite their relatives to also join. Community-based cohort with confirmed ischemic stroke through CT or MRI will be recruited through the community health-care network in the rural areas, and those agreeing to participate will invite their family members to also participate. All participants will be screened with a questionnaire, physical examinations will be given, and blood samples will be taken.

Outcomes

Type Measure Time Frame Safety Issue
Primary Genetic factors predisposing to ischemic stroke.
Secondary Gene-gene and/or gene-environment interactions involved in the etiology of ischemic stroke.

Biospecimen Retention:Samples With DNA - serum, white cells

Sponsors