Intracranial AneurysmEIIANCT00997698
Contrast-enhanced Magnetic Resonance Angiography Investigation of Intracranial Aneurysms and Prospective Study of Risk Factors
An observational study of Intracranial Aneurysm, run by Second Military Medical University at 1 site in China.
Trial summary
This is a prospective observational registry with intent to detect the prevalence of intracranial aneurysms with contrast-enhanced MR angiography (CE-MRA) at 1.5T, and to determine the risk factors such as high blood pressure and cigarette smoking relating to intracranial aneurysms. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Intracranial Aneurysm
- How many people
- 4,000 participants
- Where
- 1 siteChina
- Study dates
- Jan 2009to Jun 2011
- 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: People coming to Changhai hospital to get health check or consult docter, undergoing cerebral CE-MRA, and according with the criteria were recruited. Assuming an 8 percent prevalence of intracranial aneurysm in the general population and using a two-sided alpha value of 0.05, we estimated that 4000 persons would need to be enrolled for the study.
Who may be able to join
- Aged 20 to 80 years
- Willing to undergo study procedures
- Who are fully informed about the study and have signed the informed consent form
Who cannot join
- History of intracranial aneurysm
- History of intracranial tumor
- History of cerebral infarction
- Acute stroke
- Require emergency treatment
- Contraindication for MRI examination
Show all 9Show fewer
- Severely impaired renal functions
- Known anaphylactic reaction to MR contrast media
- Pregnancy or nursing
Trial locations and contacts
1 site in 1 country.
China1 site
Changhai Hospital, Second Military Medical University
Shanghai, Shanghai Municipality, 200433
About this study
Official title: Imaging Epidemiological Investigation of Intracranial Aneurysms and the Prospective Study of Risk Factors：Assessment of MR Imaging Trail
This is a prospective observational registry with intent to detect the prevalence of intracranial aneurysms with contrast-enhanced MR angiography (CE-MRA) at 1.5T, and to determine the risk factors such as high blood pressure and cigarette smoking relating to intracranial aneurysms.
Read the detailed description
Intracranial aneurysms are common and have been reported increased incidence rate because of the widespread use of high-resolution imaging techniques. They are clinically important because of the life-threatening rupture and hemorrhage. Early detection and diagnosis is the key of treatment. Contrast-enhanced MR angiography (CE-MRA), as a simple, sensitivity and noninvasive method, is playing an important role in Vascular Imaging. CE-MRA has been an accuracy modality for intracranial aneurysm at most centers and proved the high sensitivity and accuracy comparing with DSA. Therefore, we use CE-MRA at 1.5T as a tool of epidemiological investigation of intracranial aneurysms.
In retrospective analysis, conventional risk factors for intracranial aneurysms include hypertension, hyperlipidemia, diabetes mellitus (DM), smoking history, and family history, etc. However, retrospective analysis probably gives an underestimation or overestimation of the actual results. Prospective analysis will get accurate data on the risk factors relating to intracranial aneurysms
- Conditions
- Intracranial Aneurysm
- Keywords
- Intracranial aneurysm, Magnetic resonance angiography, Epidemiology
- Medical subject headings
- Intracranial Aneurysm
What is being measured
The primary outcome is the main question the study is designed to answer.
Intracranial aneurysms identified by CE-MRA
Measured: 24 months
Secondary outcomes (1)
Statistical analysis of the prospective factors which contribute to the development of intracranial aneurysms
Measured: 6 months after the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2009 (estimated)
- Study startJan 2009
- Primary completionDec 2010 (estimated)
- Study completionJun 2011 (estimated)
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.
- 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
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Military Medical University
- Sponsor type
- University, hospital or other
- Investigators
- Ping J Lu, MD, PhD, Study director, Changhai Hospital affiliated to Second Military Medical UniversityQi Liu, MD, PhD, Principal investigator, Changhai Hospital affiliated to Second Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00997698
- Sponsor's protocol ID
- SecondMMU
- Acronym
- EIIA
- Status last verified
- Oct 2009
- First submitted
- 18 Oct 2009
- Last updated
- 27 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging Epidemiological Investigation of Intracranial Aneurysms and the Prospective Study of Risk Factors：Assessment of MR Imaging Trail
- ClinicalTrials.gov ID
- NCT00997698
- Acronym / sponsor ID
- EIIA / SecondMMU
- Conditions
- Intracranial Aneurysm
- Keywords
- Intracranial aneurysm, Magnetic resonance angiography, Epidemiology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Second Military Medical UniversityUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 19 Oct 2009 (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.
This is a prospective observational registry with intent to detect the prevalence of intracranial aneurysms with contrast-enhanced MR angiography (CE-MRA) at 1.5T, and to determine the risk factors such as high blood pressure and cigarette smoking relating to intracranial aneurysms.
Detailed description
Intracranial aneurysms are common and have been reported increased incidence rate because of the widespread use of high-resolution imaging techniques. They are clinically important because of the life-threatening rupture and hemorrhage. Early detection and diagnosis is the key of treatment. Contrast-enhanced MR angiography (CE-MRA), as a simple, sensitivity and noninvasive method, is playing an important role in Vascular Imaging. CE-MRA has been an accuracy modality for intracranial aneurysm at most centers and proved the high sensitivity and accuracy comparing with DSA. Therefore, we use CE-MRA at 1.5T as a tool of epidemiological investigation of intracranial aneurysms.
In retrospective analysis, conventional risk factors for intracranial aneurysms include hypertension, hyperlipidemia, diabetes mellitus (DM), smoking history, and family history, etc. However, retrospective analysis probably gives an underestimation or overestimation of the actual results. Prospective analysis will get accurate data on the risk factors relating to intracranial aneurysms
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- People coming to Changhai hospital to get health check or consult docter, undergoing cerebral CE-MRA, and according with the criteria were recruited. Assuming an 8 percent prevalence of intracranial aneurysm in the general population and using a two-sided alpha value of 0.05, we estimated that 4000 persons would need to be enrolled for the study.
Key inclusion criteria (3 listed)
- Aged 20 to 80 years
- Willing to undergo study procedures
- Who are fully informed about the study and have signed the informed consent form
Key exclusion criteria (9 listed)
- History of intracranial aneurysm
- History of intracranial tumor
- History of cerebral infarction
- Acute stroke
- Require emergency treatment
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 aneurysms identified by CE-MRA
Time frame: 24 months
1 secondary outcome
Statistical analysis of the prospective factors which contribute to the development of intracranial aneurysms
Time frame: 6 months after the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2009.
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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.
Ping J Lu, MD, PhD study director
Changhai Hospital affiliated to Second Military Medical University
Qi Liu, MD, PhD principal investigator
Changhai Hospital affiliated to Second Military Medical University
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 Second Military Medical University 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 3 inclusion and 9 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 27 Oct 2009. 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?
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 aneurysms identified by CE-MRA (time frame: 24 months). 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 27 Oct 2009.