Intracranial AneurysmNCT00926172
Screening Intracranial Aneurysms With Magnetic Resonance Angiography (MRA) in China
An observational study of Intracranial Aneurysm, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
The Chinese Cerebral Aneurysms Survey is a continuing prospective study among middle-aged and older individuals (35 - 75 years) that aims to determine the prevalence of cerebral intracranial aneurysms in the general population with MRA at 3.0 Tesla (T). Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Intracranial Aneurysm
- How many people
- 4,500 participants
- Where
- 1 siteChina
- Study dates
- Jun 2007to Jun 2010
- 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The investigators recruited 4500-5000 native inhabitants aged 35-75 years lived in China according to China census-tract data from the year 2005. The gender was accordance with China census-tract data, and the population aged 35-75 years has a higher incident of intracranial aneurysm in the literature. Assuming an 8 percent prevalence of intracranial aneurysm in the general population and using a two-sided alpha value of 0.05, the investigators estimated that 4500-5000 native inhabitants would need to be enrolled for the study.
Who may be able to join
- Native inhabitants lived in a defined area sites in China
- Aged 35-75 years
Who cannot join
- Less than 35 years old or more than 75 years old
- Incompetent patient who cannot give consent for routine MR Angiography and his/her surrogate decision maker is not available
- Any patients with a contraindication to having a standard MRI examination, such as phase maker, orbital metallic foreign body, etc.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Sixth Affiliated People's Hospital, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200233
Yong-Dong Li, MD, Ph.D, 0086-21-64844183, dr_liyongdong@sina.com.cn
Ming-Hua Li, MD, Ph.D, 0086-21-64844183, liminhua@online.sh.cn
About this study
Official title: Epidemiology of Cerebral Aneurysms With MRA in China in Middle-aged or Elder Person: a Population-based Survey
The Chinese Cerebral Aneurysms Survey is a continuing prospective study among middle-aged and older individuals (35 - 75 years) that aims to determine the prevalence of cerebral intracranial aneurysms in the general population with MRA at 3.0 Tesla (T).
Read the detailed description
Cerebral intracranial aneurysms are common. In angiographic and autopsy studies, estimates for prevalence vary between 0.2 and 9.9 percent. The methods used to detect the aneurysms markedly influenced the proportion of aneurysms. Retrospective autopsy studies probably give an underestimation and prospective angiography studies an overestimation of the actual prevalence. Accurate data on the prevalence of intracranial aneurysms are essential in evaluating the results of screening programs for aneurysms in general population.
During the past decade, MRA, as a preferred accuracy modality for noninvasive intracranial vascular imaging at most centers, is playing an increasing role in the evaluation of patients suspected of having intracranial aneurysms. In recurrent study, we have tested that MRA at 3T has excellent sensitivity, accuracy, and correlation with DSA and is comparable to catheter cerebral angiography for the evaluation of patients with intracranial aneurysms (Stroke, in press). Therefore, we examined trends in intracranial aneurysm prevalence with the use of MRA at 3.0T to determine the true prevalence of cerebral intracranial aneurysms in the general middle-aged or elder population.
- Conditions
- Intracranial Aneurysm
- Keywords
- Magnetic resonance angiography, Intracranial aneurysm, cerebral aneurysm, unruptured aneurysm, Epidemiology, Magnetic Resonance Imaging
- Medical subject headings
- Intracranial Aneurysm
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral intracranial aneurysms identified by 3-D TOF-MRA at 3T
Measured: 18 months after the study
Secondary outcomes (1)
Suspected cerebral aneurysms detected by MRA underwent digital subtraction angiography (DSA) examination
Measured: 32-36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2009 (estimated)
- Study startJun 2007
- Primary completionDec 2008
- Study completionJun 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intracranial AneurysmStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe 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
- 4,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Investigators
- Ming-Hua Li, MD, PhD, Study chair, The Sixth Affiliated People's Hospital, Shanghai Jiao Tong UniversityYong-Dong Li, MD, PhD, Principal investigator, The Sixth Affiliated People's Hospital, Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00926172
- Sponsor's protocol ID
- CASC1
- Other IDs
- SAPH001
- Status last verified
- Dec 2009
- First submitted
- 19 Jun 2009
- Last updated
- 14 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Li MH, Cheng YS, Li YD, Fang C, Chen SW, Wang W, Hu DJ, Xu HW. Large-cohort comparison between three-dimensional time-of-flight magnetic resonance and rotational digital subtraction angiographies in intracranial aneurysm detection. Stroke. 2009 Sep;40(9):3127-9. doi: 10.1161/STROKEAHA.109.553800. Epub 2009 Jun 25.
PubMed 19556531
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Cerebral Aneurysms With MRA in China in Middle-aged or Elder Person: a Population-based Survey
- ClinicalTrials.gov ID
- NCT00926172
- Acronym / sponsor ID
- CASC1
- Conditions
- Intracranial Aneurysm
- Keywords
- Magnetic resonance angiography, Intracranial aneurysm, cerebral aneurysm, unruptured aneurysm, Epidemiology, Magnetic Resonance Imaging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,500 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Jun 2010 (estimated)
- First posted
- 23 Jun 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.
The Chinese Cerebral Aneurysms Survey is a continuing prospective study among middle-aged and older individuals (35 - 75 years) that aims to determine the prevalence of cerebral intracranial aneurysms in the general population with MRA at 3.0 Tesla (T).
Detailed description
Cerebral intracranial aneurysms are common. In angiographic and autopsy studies, estimates for prevalence vary between 0.2 and 9.9 percent. The methods used to detect the aneurysms markedly influenced the proportion of aneurysms. Retrospective autopsy studies probably give an underestimation and prospective angiography studies an overestimation of the actual prevalence. Accurate data on the prevalence of intracranial aneurysms are essential in evaluating the results of screening programs for aneurysms in general population.
During the past decade, MRA, as a preferred accuracy modality for noninvasive intracranial vascular imaging at most centers, is playing an increasing role in the evaluation of patients suspected of having intracranial aneurysms. In recurrent study, we have tested that MRA at 3T has excellent sensitivity, accuracy, and correlation with DSA and is comparable to catheter cerebral angiography for the evaluation of patients with intracranial aneurysms (Stroke, in press). Therefore, we examined trends in intracranial aneurysm prevalence with the use of MRA at 3.0T to determine the true prevalence of cerebral intracranial aneurysms in the general middle-aged or elder population.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators recruited 4500-5000 native inhabitants aged 35-75 years lived in China according to China census-tract data from the year 2005. The gender was accordance with China census-tract data, and the population aged 35-75 years has a higher incident of intracranial aneurysm in the literature. Assuming an 8 percent prevalence of intracranial aneurysm in the general population and using a two-sided alpha value of 0.05, the investigators estimated that 4500-5000 native inhabitants would need to be enrolled for the study.
Key inclusion criteria (2 listed)
- Native inhabitants lived in a defined area sites in China
- Aged 35-75 years
Key exclusion criteria (3 listed)
- Less than 35 years old or more than 75 years old
- Incompetent patient who cannot give consent for routine MR Angiography and his/her surrogate decision maker is not available
- Any patients with a contraindication to having a standard MRI examination, such as phase maker, orbital metallic foreign body, etc.
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
Cerebral intracranial aneurysms identified by 3-D TOF-MRA at 3T
Time frame: 18 months after the study
1 secondary outcome
Suspected cerebral aneurysms detected by MRA underwent digital subtraction angiography (DSA) examination
Time frame: 32-36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2009.
- Results publication: PubMed 19556531Li MH, Cheng YS, Li YD, Fang C, Chen SW, Wang W, Hu DJ, Xu HW. Large-cohort comparison between three-dimensional time-of-flight magnetic resonance and rotational digital subtraction angiographies in intracranial aneurysm detection. Stroke. 2009 Sep;40(9):3127-9. doi: 10.1161/STROKEAHA.109.553800. Epub 2009 Jun 25.
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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.
Ming-Hua Li, MD, PhD study chair
The Sixth Affiliated People's Hospital, Shanghai Jiao Tong University
Yong-Dong Li, MD, PhD principal investigator
The Sixth Affiliated People's Hospital, Shanghai Jiao Tong 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 Shanghai Jiao Tong University School of Medicine 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 3 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 14 Dec 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?
Contact Yong-Dong Li, MD, PhD (0086-21-64844183, dr_liyongdong@sina.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral intracranial aneurysms identified by 3-D TOF-MRA at 3T (time frame: 18 months after the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00926172, which also lists 1 linked publication.
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 14 Dec 2009.