Fangshan / Family-based Ischemic Stroke Study In China (FISSIC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2011 by Peking University
Sponsor:
Collaborators:
National Natural Science Foundation of China
Ministry of Education, China
Ministry of Science and Technology of the People´s Republic of China
Information provided by (Responsible Party):
Yonghua Hu, Peking University
ClinicalTrials.gov Identifier:
NCT00534742
First received: September 21, 2007
Last updated: December 13, 2011
Last verified: December 2011
  Purpose

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.


Condition
Stroke

Study Type: Observational
Study Design: Observational Model: Family-Based
Time Perspective: Cross-Sectional
Official Title: A Family-based Ischemic Stroke Study on Association and Interactions of Multi-pathway Genetic Polymorphisms

Resource links provided by NLM:


Further study details as provided by Peking University:

Biospecimen Retention:   Samples With DNA

serum, white cells


Estimated Enrollment: 1500
Study Start Date: June 2005
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00534742

Contacts
Contact: Xun Tang, PhD +86-10-82801528 ext 316 tangxun@bjmu.edu.cn
Contact: Dafang Chen, MD, PhD +86-10-82802644 dafangchen@bjmu.edu.cn

Locations
China
The First Hospital of Fangshan District Recruiting
Beijing, China, 102400
Contact: Zongxin Zhang, MD    +86-10-85347505    zongxinzhang@fissic.org   
Contact: Huidong Dou, MD    +86-10-85347505    huidongdou@fissic.org   
Principal Investigator: Zongxin Zhang, MD         
Sub-Investigator: Jianhua Li, MD         
Sub-Investigator: Cuiping Fu, MD         
Sponsors and Collaborators
Peking University
National Natural Science Foundation of China
Ministry of Education, China
Ministry of Science and Technology of the People´s Republic of China
Investigators
Principal Investigator: Yonghua Hu, MD Peking University School of Public Health
  More Information

Additional Information:
Publications:
Responsible Party: Yonghua Hu, Executive Dean, Peking University
ClinicalTrials.gov Identifier: NCT00534742     History of Changes
Other Study ID Numbers: NSFC-30671807, SRFDP-20060001111, 2001BA703B02, NSFC-30872173, NSFC-81102177, NSFC-81172744
Study First Received: September 21, 2007
Last Updated: December 13, 2011
Health Authority: China: Ministry of Health

Keywords provided by Peking University:
Siblings

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on July 24, 2014