Aneurysm, IntracranialNCT03117803
The Natural Course of Unruptured Intracranial Aneurysms in a Chinese Cohort
An observational study of Aneurysm, Intracranial and Natural History, run by Tang-Du Hospital at 1 site in China.
Trial summary
This is a registry study of the natural course of unruptured intracranial aneurysms (UIA). In addition, the investigators will analyze the risk factors for the rupture of the UIA and their joint effect. The investigators aim to use research data to create a China national database of UIA. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Aneurysm, Intracranial, Natural History
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2017to 30 Dec 2021
- How long will I take part?
- 1 Year
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The patients who diagnosed as unruptured intracranial aneurysms
Who may be able to join
- Diagnosis of untreated unruptured intracranial aneurysm (by CTA, MRA or DSA)
- Patient with premorbid mRS of 3 or less.
- Patient older than 18 years
- Patient consenting to participate to the study
Who cannot join
- Subarachnoid hemorrhage with unknown causes
- Patient with other cerebral arteriovenous malformations or cerebral arteriovenous fistulas
- Patient with malignant tumor
- Target aneurysm is fusiform, traumatic, mycotic, or dissecting related.
- Inability to obtain informed consent.
- Patients with a life expectancy less than 1 year
- Participating in the other clinical studies of intracranial aneurysm
- Refusal of follow-up
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tandu Hospital, Fourth Military Medical University
Xi'an, Shaanxi, 710038
Wei Guo, M.D Ph.D, 86-18729985168, 18729985168@163.com
Haixiao Liu, M.D, 86-15929315407, 56761311@qq.com
About this study
This is a registry study of the natural course of unruptured intracranial aneurysms (UIA). In addition, the investigators will analyze the risk factors for the rupture of the UIA and their joint effect. The investigators aim to use research data to create a China national database of UIA.
Read the detailed description
This is a registry study of the natural course of unruptured intracranial aneurysms (UIA). In addition, the investigators will analyze the risk factors for the rupture of the UIA and their joint effect. The investigators aim to use research data to create a China national database of UIA.
This study is supported by a research grant from the Ministry of Science and Technology of the People's Republic of China. The investigators will collaborate with the other 19 medical centers which locate in the different districts of China. During the study period, all the patients included in this study will observe and treat in the collaborating medical centers. Included patients will be followed-up for at least 1year.
Research data will represent the real natural course of UIA in China.
For this study, the investigators consulted and hired professional experts about data collection, data and methodology. An intact systematic project steering committee, including Data Monitoring Committee, Data Management Committee, Project Academic Committee, Executive Group, Project Manager, Project Statistician, and Technical Support Center has been built up. Scientific regulations have also been made.
- Conditions
- Aneurysm, Intracranial, Natural History
- Keywords
- Aneurysm, Intracranial, Registries, Multicenter Studies, People's Republic of China
- Medical subject headings
- Intracranial Aneurysm
What is being measured
The primary outcome is the main question the study is designed to answer.
aneurysm rupture rate
aneurysm rupture rate
Measured: Up to 4 years or time of aneurysm repair surgery
Secondary outcomes (1)
Morphological changes of aneurysms
maximum diameter increase ≥ 1mm or appearance of a daughter sac
Measured: Up to 4 years or time of aneurysm repair surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start1 May 2017
- Primary completion30 Dec 2020 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Aneurysm, IntracranialStudies of the same condition, open and under way.
- More trials run by Tang-Du 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
- 5,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Xuanwu Hospital, Beijing
- Responsible party
- Sponsor
- Investigators
- Yan Qu, M.D, Ph.D, Principal investigator, Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University Xi'an, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03117803
- Sponsor's protocol ID
- 2016YFC1300801
- Status last verified
- Apr 2017
- First submitted
- 4 Apr 2017
- Last updated
- 5 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: share the original data 5 years after the study completion
Publications
International Study of Unruptured Intracranial Aneurysms Investigators. Unruptured intracranial aneurysms--risk of rupture and risks of surgical intervention. N Engl J Med. 1998 Dec 10;339(24):1725-33. doi: 10.1056/NEJM199812103392401.
PubMed 9867550Wiebers DO, Whisnant JP, Huston J 3rd, Meissner I, Brown RD Jr, Piepgras DG, Forbes GS, Thielen K, Nichols D, O'Fallon WM, Peacock J, Jaeger L, Kassell NF, Kongable-Beckman GL, Torner JC; International Study of Unruptured Intracranial Aneurysms Investigators. Unruptured intracranial aneurysms: natural history, clinical outcome, and risks of surgical and endovascular treatment. Lancet. 2003 Jul 12;362(9378):103-10. doi: 10.1016/s0140-6736(03)13860-3.
PubMed 12867109UCAS Japan Investigators; Morita A, Kirino T, Hashi K, Aoki N, Fukuhara S, Hashimoto N, Nakayama T, Sakai M, Teramoto A, Tominari S, Yoshimoto T. The natural course of unruptured cerebral aneurysms in a Japanese cohort. N Engl J Med. 2012 Jun 28;366(26):2474-82. doi: 10.1056/NEJMoa1113260.
PubMed 22738097Liu H, Guo W, Xiang S, Hu P, Sun F, Gao J, Zhang X, Wang P, Jing W, Zhang L, Yang X, Duan C, He M, Zhang H, Qu Y. The natural course of unruptured intracranial aneurysms in a Chinese cohort: protocol of a multi-center registration study in CIAP. J Transl Med. 2019 Oct 22;17(1):349. doi: 10.1186/s12967-019-2092-z.
PubMed 31640726
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Natural Course of Unruptured Intracranial Aneurysms in a Chinese Cohort
- ClinicalTrials.gov ID
- NCT03117803
- Acronym / sponsor ID
- 2016YFC1300801
- Conditions
- Aneurysm, Intracranial, Natural History
- Keywords
- Aneurysm, Intracranial, Registries, Multicenter Studies, People's Republic of China
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Collaborators
- Xuanwu Hospital, Beijing
- Study start
- 1 May 2017 (actual)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 18 Apr 2017 (actual)
- 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 registry study of the natural course of unruptured intracranial aneurysms (UIA). In addition, the investigators will analyze the risk factors for the rupture of the UIA and their joint effect. The investigators aim to use research data to create a China national database of UIA.
Detailed description
This is a registry study of the natural course of unruptured intracranial aneurysms (UIA). In addition, the investigators will analyze the risk factors for the rupture of the UIA and their joint effect. The investigators aim to use research data to create a China national database of UIA.
This study is supported by a research grant from the Ministry of Science and Technology of the People's Republic of China. The investigators will collaborate with the other 19 medical centers which locate in the different districts of China. During the study period, all the patients included in this study will observe and treat in the collaborating medical centers. Included patients will be followed-up for at least 1year.
Research data will represent the real natural course of UIA in China.
For this study, the investigators consulted and hired professional experts about data collection, data and methodology. An intact systematic project steering committee, including Data Monitoring Committee, Data Management Committee, Project Academic Committee, Executive Group, Project Manager, Project Statistician, and Technical Support Center has been built up. Scientific regulations have also been made.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The patients who diagnosed as unruptured intracranial aneurysms
Key inclusion criteria (4 listed)
- Diagnosis of untreated unruptured intracranial aneurysm (by CTA, MRA or DSA)
- Patient with premorbid mRS of 3 or less.
- Patient older than 18 years
- Patient consenting to participate to the study
Key exclusion criteria (8 listed)
- Subarachnoid hemorrhage with unknown causes
- Patient with other cerebral arteriovenous malformations or cerebral arteriovenous fistulas
- Patient with malignant tumor
- Target aneurysm is fusiform, traumatic, mycotic, or dissecting related.
- Inability to obtain informed consent.
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
aneurysm rupture rate
Time frame: Up to 4 years or time of aneurysm repair surgery
aneurysm rupture rate
1 secondary outcome
Morphological changes of aneurysms
Time frame: Up to 4 years or time of aneurysm repair surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2017.
- Background: PubMed 9867550International Study of Unruptured Intracranial Aneurysms Investigators. Unruptured intracranial aneurysms--risk of rupture and risks of surgical intervention. N Engl J Med. 1998 Dec 10;339(24):1725-33. doi: 10.1056/NEJM199812103392401.
- Background: PubMed 12867109Wiebers DO, Whisnant JP, Huston J 3rd, Meissner I, Brown RD Jr, Piepgras DG, Forbes GS, Thielen K, Nichols D, O'Fallon WM, Peacock J, Jaeger L, Kassell NF, Kongable-Beckman GL, Torner JC; International Study of Unruptured Intracranial Aneurysms Investigators. Unruptured intracranial aneurysms: natural history, clinical outcome, and risks of surgical and endovascular treatment. Lancet. 2003 Jul 12;362(9378):103-10. doi: 10.1016/s0140-6736(03)13860-3.
- Background: PubMed 22738097UCAS Japan Investigators; Morita A, Kirino T, Hashi K, Aoki N, Fukuhara S, Hashimoto N, Nakayama T, Sakai M, Teramoto A, Tominari S, Yoshimoto T. The natural course of unruptured cerebral aneurysms in a Japanese cohort. N Engl J Med. 2012 Jun 28;366(26):2474-82. doi: 10.1056/NEJMoa1113260.
- Derived from this study: PubMed 31640726Liu H, Guo W, Xiang S, Hu P, Sun F, Gao J, Zhang X, Wang P, Jing W, Zhang L, Yang X, Duan C, He M, Zhang H, Qu Y. The natural course of unruptured intracranial aneurysms in a Chinese cohort: protocol of a multi-center registration study in CIAP. J Transl Med. 2019 Oct 22;17(1):349. doi: 10.1186/s12967-019-2092-z.
- Individual participant dataSharing planned: Yes. share the original data 5 years after the study completion
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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.
Yan Qu, M.D, Ph.D principal investigator
Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University Xi'an, China
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 Aneurysm, Intracranial and Natural History, run by Tang-Du 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 4 inclusion and 8 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 5 Jul 2017. 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 Wei Guo, M.D, Ph.D (86-18729985168, 18729985168@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
aneurysm rupture rate (time frame: Up to 4 years or time of aneurysm repair surgery). 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 NCT03117803, which also lists 4 linked publications.
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 5 Jul 2017.