Methods of Etiological Diagnosis of Cerebral Amyloid Angiopathy

• Conditions: Cerebral Amyloid Angiopathy; Intracerebral Hemorrhage

• Registration Number: NCT02361411
• Lead Sponsor: Peking University Third Hospital

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

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 Timeline

• Status Verified: 2015-02
• Study Start: 2015-02
• Study First Submitted: 2015-02-03
• Study First Submitted QC: 2015-02-06
• Last Update Submitted: 2015-02-06
• Study First Posted: 2015-02-11
• Last Update Posted: 2015-02-11
• Primary Completion: 2016-03
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

①diagnosed wiht spontaneous cerebral hemorrhage after the head CT.

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
apolipoprotein E gene polymorphism	baseline

Secondary Outcome Measures

Name	Time	Method
recurrence of cerebral hemorrhage	1 year
CMBs were evaluated using the Microbleed Anatomical Rating Scale (MARS)	baseline
a composite outcome including multiple dot and blot hemorrhages and microaneurysms of the fundus	baseline

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, China