Clinical trial NCT02361411: Methods of Etiological Diagnosis of Cerebral Amyloid Angiopathy
Official title: A Research of the Methods of Etiological Diagnosis of Cerebral Amyloid Angiopathy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cerebral Amyloid Angiopathy
Intracerebral Hemorrhage
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Municipal Science & Technology Commission
First posted: 2015-02-11
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We recruited consecutive patients with intracerebral hemorrhage.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: apolipoprotein E gene polymorphism
timeFrame: baseline
Secondary outcomes:
measure: CMBs were evaluated using the Microbleed Anatomical Rating Scale (MARS)
timeFrame: baseline
measure: a composite outcome including multiple dot and blot hemorrhages and microaneurysms of the fundus
timeFrame: baseline
measure: recurrence of cerebral hemorrhage
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
affiliation: Peking University Third Hospital
name: Dongsheng Fan, doctor
role: PRINCIPAL_INVESTIGATOR
References: