Cerebrovascular events in adult Takayasu arteritis
| ISRCTN | ISRCTN11428053 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11428053 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Affiliated Chuiyangliu Hospital of Tsinghua University |
| Funder | Investigator initiated and funded |
- Submission date
- 21/02/2025
- Registration date
- 27/02/2025
- Last edited
- 27/02/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Takayasu arteritis (TA) is a disease that causes inflammation in large blood vessels, mainly the aorta and its main branches. The cause of TA is unknown. Because TA is rare, we don't fully understand the symptoms and long-term effects in Chinese adults who have cardiovascular events (CVEs). This study aimed to (1) describe the clinical features of CVEs in adults with TA; and (2) summarize the treatment methods and outcomes for stroke patients, focusing on death rates and the chances of having another stroke or transient ischemic attack (TIA).
Who can participate?
Inpatients aged 18 years and over who were admitted to hospital with TA
What does the study involve?
The researchers reviewed the medical records of patients with TA who underwent aortic angiography, computed tomography angiogram (CTA) or magnetic resonance angiography (MRA) between January 2000 to December 2024. The incidence, clinical features, management strategy and prognosis of these patients were evaluated.
What are the possible benefits and risks of participating?
This is a retrospective study. There are no possible benefits or risks of participating.
Where is the study run from?
Affiliated Chuiyangliu Hospital of Tsinghua University.
When is the study starting and how long is it expected to run for?
January 2025 to February 2025
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Prof. Junting Huo, huojunting301@163.com
Contact information
Public, Principal investigator
Chuiyangliu South Street 2
Beijing
100022
China
| Phone | +86 (0)13321123960 |
|---|---|
| huojunting301@163.com |
Scientific
100853 Fuxing Road 28
Beijing
100853
China
| Phone | +86 (0)15801612879 |
|---|---|
| gaolinggen@163.com |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational cohort study |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | Clinical characteristics and outcomes of cerebrovascular events in adult Takayasu arteritis: a cohort study of 182 patients |
| Study objectives | Because of the rarity of Takayasu arteritis (TA), clinical characteristics and long-term outcomes of Chinese adult TA patients with cerebrovascular events (CVEs) have not been fully elucidated. This study aimed to: 1. Describe the ratio and clinical features of CVEs in adult TA patients 2. Summarize the therapeutic strategy and the prognosis of stroke patients, focusing on mortality and recurrence of stroke/transient ischaemic attack (TIA). |
| Ethics approval(s) |
Approved 05/12/2024, Ethics committee of Chuiyangliu Hospital (Chuiyangliu South Street 2, Beijing, 100022, China; +86 (0)10 6770 0622; chuiyangliucyl@163.com), ref: SOP-CYLIRB-2.0 |
| Health condition(s) or problem(s) studied | Cerebrovascular events in adult Takayasu arteritis |
| Intervention | The researchers retrospectively collected 1071 TA subjects and enrolled the patients with CVEs between January 2000 and December 2024. The incidence, clinical features, management strategy and prognosis of these patients were evaluated. |
| Intervention type | Other |
| Primary outcome measure(s) |
All-cause mortality at 1, 6, 12 months and every year, collected from medical records |
| Key secondary outcome measure(s) |
Recurrence of stroke/TIA at 1, 6, 12 months and every year, collected from medical records |
| Completion date | 21/02/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | All |
| Target sample size at registration | 150 |
| Total final enrolment | 182 |
| Key inclusion criteria | Adult patients with TA fulfilling the criteria of the American College of Rheumatology |
| Key exclusion criteria | Clinical remission criteria: absence of new symptoms and normalized erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) |
| Date of first enrolment | 01/01/2000 |
| Date of final enrolment | 31/12/2024 |
Locations
Countries of recruitment
- China
Study participating centre
Chuiyangliu South Street
Beijing
100022
China
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Published as a supplement to the results publication |
| IPD sharing plan | The participant-level data is expected to be made available in the published paper. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
26/02/2025: Study's existence confirmed by the ethics committee of Chuiyangliu Hospital.
