Cerebral Amyloid AngiopathyNCT02361411
Methods of Etiological Diagnosis of Cerebral Amyloid Angiopathy
An observational study of Cerebral Amyloid Angiopathy and Intracerebral Hemorrhage, run by Peking University Third Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cerebral Amyloid Angiopathy, Intracerebral Hemorrhage
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- Feb 2015to Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: We recruited consecutive patients with intracerebral hemorrhage.
Who may be able to join
- ①diagnosed wiht spontaneous cerebral hemorrhage after the head CT.
- ② the patients and their family members agreed to participate in this study.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Research of the Methods of Etiological Diagnosis of Cerebral Amyloid Angiopathy
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
Read the 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.
- Medical subject headings
- Cerebral Amyloid Angiopathy, Cerebral Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
apolipoprotein E gene polymorphism
Measured: baseline
Secondary outcomes (3)
CMBs were evaluated using the Microbleed Anatomical Rating Scale (MARS)
Measured: baseline
a composite outcome including multiple dot and blot hemorrhages and microaneurysms of the fundus
Measured: baseline
recurrence of cerebral hemorrhage
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionMar 2016 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Amyloid AngiopathyStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Municipal Science & Technology Commission
- Responsible party
- Principal investigator, Fan Dongsheng, Peking University Third Hospital
- Investigators
- Dongsheng Fan, doctor, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02361411
- Sponsor's protocol ID
- PUTH-2014191
- Status last verified
- Feb 2015
- First submitted
- 3 Feb 2015
- Last updated
- 11 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Research of the Methods of Etiological Diagnosis of Cerebral Amyloid Angiopathy
- ClinicalTrials.gov ID
- NCT02361411
- Acronym / sponsor ID
- PUTH-2014191
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Beijing Municipal Science & Technology Commission
- Study start
- Feb 2015
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 11 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- We recruited consecutive patients with intracerebral hemorrhage.
Key inclusion criteria (2 listed)
- ①diagnosed wiht spontaneous cerebral hemorrhage after the head CT.
- ② the patients and their family members agreed to participate in this study.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
apolipoprotein E gene polymorphism
Time frame: baseline
3 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dongsheng Fan, doctor principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Amyloid Angiopathy and Intracerebral Hemorrhage, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dongsheng Fan, doctor (+861082266699, dsfan@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
apolipoprotein E gene polymorphism (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2015.