Methods of Etiological Diagnosis of Cerebral Amyloid Angiopathy

NCT ID: NCT02361411

Last Updated: 2015-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-28

Study Completion Date

2017-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cerebral Amyloid Angiopathy Intracerebral Hemorrhage

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Beijing Municipal Science & Technology Commission

OTHER

Sponsor Role collaborator

Peking University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Fan Dongsheng

Chairman of the department of neurolog of Peking University Third Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Dongsheng Fan, doctor

Role: PRINCIPAL_INVESTIGATOR

Peking University Third Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Peking University Third Hospital

Beijing, , China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Dongsheng Fan, doctor

Role: CONTACT

+861082266699

Qiong Yang, doctor

Role: CONTACT

+861082265694

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PUTH-2014191

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.