Intracranial AneurysmNCT01078506
Prevalence of Intracranial Aneurysm in Hong Kong Chinese
An observational study of Intracranial Aneurysm, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
Intracranial aneurysm (localized dilatation in weakened blood vessel wall) rupture is a catastrophic disease, with half of the victims died and many of the survivors disabled. There is currently no data in the literature for the Chinese population concerning the prevalence, characteristics (location and size) and risk… Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Intracranial Aneurysm
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Jan 2010to Jan 2013
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Hong Kong Chinese without a history of known intracranial pathologies
Who may be able to join
- Healthy adults aged between 21 and 65 years
Who cannot join
- Contraindications to MRI
- History of known intracranial pathologies
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Surgery, The Chinese University of Hong Kong
Hong Kong
About this study
Intracranial aneurysm (localized dilatation in weakened blood vessel wall) rupture is a catastrophic disease, with half of the victims died and many of the survivors disabled. There is currently no data in the literature for the Chinese population concerning the prevalence, characteristics (location and size) and risk of harboring an unruptured intracranial aneurysm. In this study, the investigators aim to study the population prevalence and characteristics (location and size) of intracranial aneurysm in Hong Kong Chinese, and its cost-effectiveness. The screening is carried out using magnetic resonance angiography (MRA), with a 3-T magnetic resonance system, which is a well-established non-invasive method for intracranial aneurysm detection.
Read the detailed description
As charted below.
- Conditions
- Intracranial Aneurysm
- Keywords
- Chinese, intracranial aneurysm, magnetic resonance imaging
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hong Kong Chinese | Without a history of known intracranial pathologies. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intracranial aneurysm
Measured: Three years
Secondary outcomes (1)
Other intracranial pathologies
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2010 (estimated)
- Study startJan 2010
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial AneurysmStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, George KC Wong, Chinese University of Hong Kong
- Investigators
- George KC Wong, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01078506
- Sponsor's protocol ID
- GW006
- Status last verified
- Apr 2013
- First submitted
- 26 Feb 2010
- Last updated
- 23 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Intracranial Aneurysm in Hong Kong Chinese
- ClinicalTrials.gov ID
- NCT01078506
- Acronym / sponsor ID
- GW006
- Conditions
- Intracranial Aneurysm
- Keywords
- Chinese, intracranial aneurysm, magnetic resonance imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 2 Mar 2010 (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.
Intracranial aneurysm (localized dilatation in weakened blood vessel wall) rupture is a catastrophic disease, with half of the victims died and many of the survivors disabled. There is currently no data in the literature for the Chinese population concerning the prevalence, characteristics (location and size) and risk of harboring an unruptured intracranial aneurysm. In this study, the investigators aim to study the population prevalence and characteristics (location and size) of intracranial aneurysm in Hong Kong Chinese, and its cost-effectiveness. The screening is carried out using magnetic resonance angiography (MRA), with a 3-T magnetic resonance system, which is a well-established non-invasive method for intracranial aneurysm detection.
Detailed description
As charted below.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hong Kong Chinese | – | –Without a history of known intracranial pathologies. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Hong Kong Chinese without a history of known intracranial pathologies
Key inclusion criteria (1 listed)
- Healthy adults aged between 21 and 65 years
Key exclusion criteria (2 listed)
- Contraindications to MRI
- History of known intracranial pathologies
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
Intracranial aneurysm
Time frame: Three years
1 secondary outcome
Other intracranial pathologies
Time frame: Three years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2013.
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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.
George KC Wong principal investigator
Chinese University of Hong Kong
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 Intracranial Aneurysm, run by Chinese University of Hong Kong 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 1 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: finished, as of the sponsor's last update on 23 Apr 2013. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intracranial aneurysm (time frame: Three years). 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 23 Apr 2013.