Methods of Etiological Diagnosis of Cerebral Amyloid Angiopathy

Intracerebral Hemorrhage Clinical Trial

Official title:

A Research of the Methods of Etiological Diagnosis of Cerebral Amyloid Angiopathy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02361411
• Other study ID #: PUTH-2014191
• 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

Related Conditions & MeSH terms

• Cerebral Amyloid Angiopathy
• Cerebral Hemorrhage
• Intracerebral Hemorrhage

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