Methods of Etiological Diagnosis of Cerebral Amyloid Angiopathy

Sponsor
Peking University Third Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02361411
Collaborator
Beijing Municipal Science & Technology Commission (Other)
1,000
1
24.9
40.1

Study Details

Study Description

Brief Summary

The purpose of this study is to

  1. Early identify patients based on clinical manifestation, imaging, gene and histology, explore diagnostic tools

  2. get gene repertoire of Chinese

  3. Build a cerebral amyloid angiopathy (CAA) prospective cohorts, observing the disease history, and exploring prognostic factors of hemorrhage in CAA patients

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    We recruited consecutive patients with intracerebral hemorrhage(ICH). Clinical data and the results of laboratory tests and CT will be assessed and recorded. All the subjects will get gene tests including many genes related with Aβ and small vessel disease (Next-generation sequencing and target enrichment system) .

    The result of the MRI Scans including cerebral microbleeds(CMBs)、Cortical superficial siderosis(cSS), white matter change(WMC) and enlarged perivascular spaces (EPVS) will be assessed using scales. Ocular fundus exams such as funduscopy and imaging will be used to assess multiple dot and blot hemorrhages and microaneurysms by ophthalmologist. Mini-mental state examination(MMSE) will be used to assess the cognitive function.

    Patients who need operation on the hematoma for the treatment will accept a brain tissue pathological exams According to this, a prospective cohort of CAA patients based on clinical manifestation, imaging, gene and histology will be built, and diagnostic tools such as gene and MRI results, etc will be explored. And we will get gene repertoire of Chinese patient with ICH.

    Then, the subjects will be followed up on 30-day, 3-month, 6-month, and 1-year.The patients' clinical outcome will be assessed , and the results of laboratory tests and therapy will be recorded. Prognostic factors of patients with CAA related ICH will be explored.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Research of the Methods of Etiological Diagnosis of Cerebral Amyloid Angiopathy
    Study Start Date :
    Feb 1, 2015
    Anticipated Primary Completion Date :
    Mar 1, 2016
    Anticipated Study Completion Date :
    Mar 1, 2017

    Outcome Measures

    Primary Outcome Measures

    1. apolipoprotein E gene polymorphism [baseline]

    Secondary Outcome Measures

    1. CMBs were evaluated using the Microbleed Anatomical Rating Scale (MARS) [baseline]

    2. a composite outcome including multiple dot and blot hemorrhages and microaneurysms of the fundus [baseline]

    3. recurrence of cerebral hemorrhage [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    ①diagnosed wiht spontaneous cerebral hemorrhage after the head CT.

    ② the patients and their family members agreed to participate in this study.

    Exclusion Criteria:

    ①cerebral hemorrhage caused by traumatic, cerebral infarction, tumor and arteriovenous malformation.

    ②patients who can not provide reliable information or are considered unsuitable for the study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Peking University Third Hospital Beijing China 100191

    Sponsors and Collaborators

    • Peking University Third Hospital
    • Beijing Municipal Science & Technology Commission

    Investigators

    • Principal Investigator: Dongsheng Fan, doctor, Peking University Third Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fan Dongsheng, Chairman of the department of neurolog of Peking University Third Hospital, Peking University Third Hospital
    ClinicalTrials.gov Identifier:
    NCT02361411
    Other Study ID Numbers:
    • PUTH-2014191
    First Posted:
    Feb 11, 2015
    Last Update Posted:
    Feb 11, 2015
    Last Verified:
    Feb 1, 2015

    Study Results

    No Results Posted as of Feb 11, 2015