NCT00534742

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

September 21, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 26, 2007

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 14, 2011

Status Verified

December 1, 2011

Enrollment Period

10.5 years

First QC Date

September 21, 2007

Last Update Submit

December 13, 2011

Conditions

Keywords

Siblings

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study 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.

You may qualify if:

  • Diagnosis of at least one ischemic stroke confirmed by the study neurologist on the basis of history, medical records, and head imaging by CT or MRI;
  • At least 18 years old by the time of enrolment in the study;
  • At least one full sibling or parent alive in areas nearby;
  • Written informed consent by the patient or surrogate.

You may not qualify if:

  • Diagnosis of Transient Ischemic Attack (TIA) only;
  • Diagnosis of vasospasm after subarachnoid hemorrhage;
  • Diagnosis of some Mendelian disorders: CADASIL, Fabry disease, MELAS, or sickle cell anaemia;
  • Diagnosis of iatrogenic ischemic stroke associated with a surgical / interventional procedure such as coronary artery bypass grafting, carotid endarterectomy, or heart valve surgery;
  • Diagnosis of ischemic stroke associated with autoimmune condition or endocarditis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Hospital of Fangshan District

Beijing, 102400, China

RECRUITING

Related Publications (1)

  • Tang X, Hu Y, Chen D, Zhan S, Zhang Z, Dou H. The Fangshan/Family-based Ischemic Stroke Study In China (FISSIC) protocol. BMC Med Genet. 2007 Sep 10;8:60. doi: 10.1186/1471-2350-8-60.

    PMID: 17825112BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

serum, white cells

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Yonghua Hu, MD

    Peking University School of Public Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Executive Dean

Study Record Dates

First Submitted

September 21, 2007

First Posted

September 26, 2007

Study Start

June 1, 2005

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

December 14, 2011

Record last verified: 2011-12

Locations