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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02361411
Other study ID # PUTH-2014191
Secondary ID
Status Not yet recruiting
Phase N/A
First received February 3, 2015
Last updated February 6, 2015
Start date February 2015
Est. completion date March 2017

Study information

Verified date February 2015
Source Peking University Third Hospital
Contact Dongsheng Fan, doctor
Phone +861082266699
Email dsfan@sina.com
Is FDA regulated No
Health authority China: Beijing Municipal Science and Technology Commission
Study type Observational

Clinical Trial 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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1000
Est. completion date March 2017
Est. primary completion date March 2016
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

?diagnosed wiht spontaneous cerebral hemorrhage after the head CT.

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

Exclusion Criteria:

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

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
China Peking University Third Hospital Beijing

Sponsors (2)

Lead Sponsor Collaborator
Peking University Third Hospital Beijing Municipal Science & Technology Commission

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary apolipoprotein E gene polymorphism baseline No
Secondary CMBs were evaluated using the Microbleed Anatomical Rating Scale (MARS) baseline No
Secondary a composite outcome including multiple dot and blot hemorrhages and microaneurysms of the fundus baseline No
Secondary recurrence of cerebral hemorrhage 1 year No
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