Methods of Etiological Diagnosis of Cerebral Amyloid Angiopathy
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|ClinicalTrials.gov Identifier: NCT02361411|
Recruitment Status : Unknown
Verified February 2015 by Fan Dongsheng, Peking University Third Hospital.
Recruitment status was: Not yet recruiting
First Posted : February 11, 2015
Last Update Posted : February 11, 2015
The purpose of this study is to
- Early identify patients based on clinical manifestation, imaging, gene and histology, explore diagnostic tools
- get gene repertoire of Chinese
- Build a cerebral amyloid angiopathy (CAA) prospective cohorts, observing the disease history, and exploring prognostic factors of hemorrhage in CAA patients
|Condition or disease|
|Cerebral Amyloid Angiopathy Intracerebral Hemorrhage|
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 Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||A Research of the Methods of Etiological Diagnosis of Cerebral Amyloid Angiopathy|
|Study Start Date :||February 2015|
|Estimated Primary Completion Date :||March 2016|
|Estimated Study Completion Date :||March 2017|
- apolipoprotein E gene polymorphism [ Time Frame: baseline ]
- CMBs were evaluated using the Microbleed Anatomical Rating Scale (MARS) [ Time Frame: baseline ]
- a composite outcome including multiple dot and blot hemorrhages and microaneurysms of the fundus [ Time Frame: baseline ]
- recurrence of cerebral hemorrhage [ Time Frame: 1 year ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02361411
|Contact: Dongsheng Fan, firstname.lastname@example.org|
|Contact: Qiong Yang, email@example.com|
|Peking University Third Hospital|
|Beijing, China, 100191|
|Principal Investigator:||Dongsheng Fan, doctor||Peking University Third Hospital|