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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
Sponsor:
Collaborator:
Beijing Municipal Science & Technology Commission
Information provided by (Responsible Party):
Fan Dongsheng, 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

Condition or disease
Cerebral Amyloid Angiopathy Intracerebral Hemorrhage

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.


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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
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





Primary Outcome Measures :
  1. apolipoprotein E gene polymorphism [ Time Frame: baseline ]

Secondary Outcome Measures :
  1. CMBs were evaluated using the Microbleed Anatomical Rating Scale (MARS) [ Time Frame: baseline ]
  2. a composite outcome including multiple dot and blot hemorrhages and microaneurysms of the fundus [ Time Frame: baseline ]
  3. recurrence of cerebral hemorrhage [ Time Frame: 1 year ]

Biospecimen Retention:   Samples With DNA
blood brain tissure


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
We recruited consecutive patients with intracerebral hemorrhage.
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.


Information from the National Library of Medicine

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


Contacts
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Contact: Dongsheng Fan, doctor +861082266699 dsfan@sina.com
Contact: Qiong Yang, doctor +861082265694 qwertycn@163.com

Locations
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China
Peking University Third Hospital
Beijing, China, 100191
Sponsors and Collaborators
Peking University Third Hospital
Beijing Municipal Science & Technology Commission
Investigators
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Principal Investigator: Dongsheng Fan, doctor Peking University Third Hospital

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Responsible Party: Fan Dongsheng, Chairman of the department of neurolog of Peking University Third Hospital, Peking University Third Hospital
ClinicalTrials.gov Identifier: NCT02361411     History of Changes
Other Study ID Numbers: PUTH-2014191
First Posted: February 11, 2015    Key Record Dates
Last Update Posted: February 11, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
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Hemorrhage
Amyloidosis
Cerebral Hemorrhage
Cerebral Amyloid Angiopathy
Cerebral Amyloid Angiopathy, Familial
Pathologic Processes
Proteostasis Deficiencies
Metabolic Diseases
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Cerebral Arterial Diseases
Intracranial Arterial Diseases
Brain Diseases, Metabolic, Inborn
Brain Diseases, Metabolic
Cerebral Small Vessel Diseases
Amyloidosis, Familial
Metabolism, Inborn Errors
Genetic Diseases, Inborn