Takayasu ArteritisTA-ChinaNCT03199183
Registration Study of Takayasu's Arteritis in China
An observational study of Takayasu Arteritis, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
Takayasu arteritis(TA) is a chronic progressive vasculitis predominantly affecting the aorta and its major branches. The demographic, clinical and prognostic features of Takayasu arteritis in China remains in uncertainties. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Takayasu Arteritis
- What is being tested?
- PET-CT, laboratory biomarker analysis and genetic sequencing
- Type of treatment
- Surgery or procedure
- How many people
- 1,067 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2017to 1 Jul 2020
- How long will I take part?
- 12 Months
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Takayasu arteritis patients diagnosed in all participant centers.
Who may be able to join
- All of the patients diagnosed in participating clinical centers with Takayasu arteritis fulfilled the American College of Rheumatology 1990 criteria for the classification of Takayasu arteritis or the 1996 revised diagnostic criteria for Takayasu arteritis from Ishikawa K by Sharma BK et al. Patients highly suspected as Takayasu arteritis but uncertain in local centers can apply for assistant diagnosis of senior medical institutions.
Who cannot join
- Manifestations caused by other diseases: atherosclerosis, fibromuscular dysplasia, Bechet's disease, giant cell arteritis, congenital vascular malformation, syphilis and other infections resulting in vasculitis.
- Pregnant women and lactating women.
- None indications for Takayasu arteritis from ultrasound, computed tomographic angiography, magnetic resonance angiography, digital subtraction angiography.
- Absence of patient consents or dropout during the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese Academy of Medical Sciences Fuwai Hospital
Beijing, Beijing Municipality, Xichen District
Huimin Zhang, MD., 010-88398249, fwzhanghuimin@163.com
Jun Cai, MD.PhD., 010-88322165, caijun@fuwaihospital.org
About this study
Takayasu arteritis(TA) is a chronic progressive vasculitis predominantly affecting the aorta and its major branches. The demographic, clinical and prognostic features of Takayasu arteritis in China remains in uncertainties. Investigators aim to setup a national registration study for Takayasu arteritis, to observe the prevalence, clinical manifestations, natural history, survival, progression, diagnostic and therapeutic methods of the disease in China.
Read the detailed description
Objective: The study aims to investigate the demographic, clinical and prognostic features and to draw the diagnostic and therapeutic algorithm of Takayasu arteritis in China.
Study Type: A national, multicenter, observational, ambispective cohort study.
Study Design: The cardinal contents of this registry study are as follows:
- Select representative clinical centers through typical sampling methods and train the local investigators in basic knowledge of Takayasu arteritis. Introduce the Electronic Data Capture System and train in completing case report forms.
- Collect demographic, clinical, imaging, laboratory, diagnostic and therapeutic information of Takayasu arteritis patients hospitalized from Jan 1st 2002 to now. Build a baseline database of Takayasu arteritis patients.
- Recruit new diagnosed Takayasu arteritis patients in future 2 years from 2017 or till reaching a total of 1067 registered patients.
- Gather the 3-month, 6-month, 1-year follow up information including general, clinical, therapeutic, prognostic data of all recruits and build up the follow-up database.
- Establish bio-bank for serum/plasma, urine, stool, tissues or cells.
Data management, quality control and statistic analysis: Electronic Data Capture System has been built and the investigators will manage and analyze data in align with key indicators. The investigators have invited professional statistic analysts to assist analyzing data and a third party to supervise data quality.
Ethics: The Ethics Committee of Fuwai Hospital approved this study and following ethical supports from participating centers are required. Informed consents before patient enrollment are required.
- Conditions
- Takayasu Arteritis
- Being tested
- PET-CT, laboratory biomarker analysis, genetic sequencing
- Keywords
- Takayasu Arteritis, registry
- Medical subject headings
- Takayasu Arteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET-CTRadiation
PET-CT will be proceed on the basis of clinical status and aspiration of individual patient. The imaging results will be analysed by professional radiologists.
laboratory biomarker analysisOther
Screening of potential biomarkers related to Takayasu arteritis and verification tests will be operated.
genetic sequencingGenetic
Genetic sequencing results will be analysed to identify susceptible alleles or single nucleotide polymorphisms of Takayasu arteritis.
| Study group | Role | What they receive |
|---|---|---|
| Takayasu arteritis | All recruited Takayasu arteritis patients. Receives: Radiation: PET-CT; Other: laboratory biomarker analysis; Genetic: genetic sequencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence rate
the percentage of Takayasu arteritis patients among general population (estimated) during one-year period
Measured: 1 year
Secondary outcomes (2)
survival rate or mortality rate
the percentage of alive or dead recruits
Measured: 1 year, at 3-month interval
rehospitalization rate
the percentage of readmission to hospitals or centers
Measured: 1 year, at 3-month interval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2017
- Study start1 Jan 2017
- Primary completion1 Jul 2020 (estimated)
- Study completion1 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Takayasu ArteritisStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe 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
- Other
- Enrolment
- 1,067 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Huimin Zhang, MD., Principal investigator, Chinese Academy of Medical Sciences, Fuwai HospitalJun Cai, MD.PhD., Principal investigator, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03199183
- Sponsor's protocol ID
- 2016-ZX43
- Acronym
- TA-China
- Status last verified
- Jan 2019
- First submitted
- 23 Jun 2017
- Last updated
- 25 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Consent for sharing of non identifiable study data for regulatory authorities.
Publications
Ishikawa K. Diagnostic approach and proposed criteria for the clinical diagnosis of Takayasu's arteriopathy. J Am Coll Cardiol. 1988 Oct;12(4):964-72. doi: 10.1016/0735-1097(88)90462-7.
PubMed 2901440Arend WP, Michel BA, Bloch DA, Hunder GG, Calabrese LH, Edworthy SM, Fauci AS, Leavitt RY, Lie JT, Lightfoot RW Jr, et al. The American College of Rheumatology 1990 criteria for the classification of Takayasu arteritis. Arthritis Rheum. 1990 Aug;33(8):1129-34. doi: 10.1002/art.1780330811.
PubMed 1975175Yang L, Zhang H, Jiang X, Zou Y, Qin F, Song L, Guan T, Wu H, Xu L, Liu Y, Zhou X, Bian J, Hui R, Zheng D. Clinical manifestations and longterm outcome for patients with Takayasu arteritis in China. J Rheumatol. 2014 Dec;41(12):2439-46. doi: 10.3899/jrheum.140664. Epub 2014 Oct 1.
PubMed 25274886Sharma BK, Jain S, Suri S, Numano F. Diagnostic criteria for Takayasu arteritis. Int J Cardiol. 1996 Aug;54 Suppl:S141-7. doi: 10.1016/s0167-5273(96)88783-3.
PubMed 9119516Fan L, Yang L, Wei D, Ma W, Lou Y, Song L, Bian J, Zhang H, Cai J. Clinical Scenario and Long-Term Outcome of Childhood Takayasu Arteritis Undergoing 121 Endovascular Interventions: A Large Cohort Over a Fifteen-Year Period. Arthritis Care Res (Hoboken). 2021 Nov;73(11):1678-1688. doi: 10.1002/acr.24387. Epub 2021 Oct 13.
PubMed 32702156Fan L, Zhang H, Cai J, Yang L, Wei D, Yu J, Fan J, Song L, Ma W, Lou Y. Clinical Course, Management, and Outcomes of Pediatric Takayasu Arteritis Initially Presenting With Hypertension: A 16-year overview. Am J Hypertens. 2019 Sep 24;32(10):1021-1029. doi: 10.1093/ajh/hpz103.
PubMed 31278892Fan L, Zhang H, Cai J, Yang L, Liu B, Wei D, Yu J, Fan J, Song L, Ma W, Zhou X, Wu H, Lou Y. Clinical course and prognostic factors of childhood Takayasu's arteritis: over 15-year comprehensive analysis of 101 patients. Arthritis Res Ther. 2019 Jan 22;21(1):31. doi: 10.1186/s13075-018-1790-x.
PubMed 30670069
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registration Study of Takayasu's Arteritis in China
- ClinicalTrials.gov ID
- NCT03199183
- Acronym / sponsor ID
- TA-China / 2016-ZX43
- Conditions
- Takayasu Arteritis
- Keywords
- Takayasu Arteritis, registry
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,067 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jul 2020 (estimated)
- Study completion
- 1 Jul 2020 (estimated)
- First posted
- 26 Jun 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.
Takayasu arteritis(TA) is a chronic progressive vasculitis predominantly affecting the aorta and its major branches. The demographic, clinical and prognostic features of Takayasu arteritis in China remains in uncertainties. Investigators aim to setup a national registration study for Takayasu arteritis, to observe the prevalence, clinical manifestations, natural history, survival, progression, diagnostic and therapeutic methods of the disease in China.
Detailed description
Objective: The study aims to investigate the demographic, clinical and prognostic features and to draw the diagnostic and therapeutic algorithm of Takayasu arteritis in China.
Study Type: A national, multicenter, observational, ambispective cohort study.
Study Design: The cardinal contents of this registry study are as follows:
- Select representative clinical centers through typical sampling methods and train the local investigators in basic knowledge of Takayasu arteritis. Introduce the Electronic Data Capture System and train in completing case report forms.
- Collect demographic, clinical, imaging, laboratory, diagnostic and therapeutic information of Takayasu arteritis patients hospitalized from Jan 1st 2002 to now. Build a baseline database of Takayasu arteritis patients.
- Recruit new diagnosed Takayasu arteritis patients in future 2 years from 2017 or till reaching a total of 1067 registered patients.
- Gather the 3-month, 6-month, 1-year follow up information including general, clinical, therapeutic, prognostic data of all recruits and build up the follow-up database.
- Establish bio-bank for serum/plasma, urine, stool, tissues or cells.
Data management, quality control and statistic analysis: Electronic Data Capture System has been built and the investigators will manage and analyze data in align with key indicators. The investigators have invited professional statistic analysts to assist analyzing data and a third party to supervise data quality.
Ethics: The Ethics Committee of Fuwai Hospital approved this study and following ethical supports from participating centers are required. Informed consents before patient enrollment are required.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Takayasu arteritis | – | Radiation: PET-CT, Other: laboratory biomarker analysis, Genetic: genetic sequencingAll recruited Takayasu arteritis patients. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Takayasu arteritis patients diagnosed in all participant centers.
Key inclusion criteria (1 listed)
- All of the patients diagnosed in participating clinical centers with Takayasu arteritis fulfilled the American College of Rheumatology 1990 criteria for the classification of Takayasu arteritis or the 1996 revised diagnostic criteria for Takayasu arteritis from Ishikawa K by Sharma BK et al. Patients highly suspected as Takayasu arteritis but uncertain in local centers can apply for assistant diagnosis of senior medical institutions.
Key exclusion criteria (4 listed)
- Manifestations caused by other diseases: atherosclerosis, fibromuscular dysplasia, Bechet's disease, giant cell arteritis, congenital vascular malformation, syphilis and other infections resulting in vasculitis.
- Pregnant women and lactating women.
- None indications for Takayasu arteritis from ultrasound, computed tomographic angiography, magnetic resonance angiography, digital subtraction angiography.
- Absence of patient consents or dropout during the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET-CTPET-CT will be proceed on the basis of clinical status and aspiration of individual patient. The imaging results will be analysed by professional radiologists. | Radiation | Takayasu arteritis |
| laboratory biomarker analysisScreening of potential biomarkers related to Takayasu arteritis and verification tests will be operated. | Other | Takayasu arteritis |
| genetic sequencingGenetic sequencing results will be analysed to identify susceptible alleles or single nucleotide polymorphisms of Takayasu arteritis. | Genetic | Takayasu arteritis |
Primary outcome
prevalence rate
Time frame: 1 year
the percentage of Takayasu arteritis patients among general population (estimated) during one-year period
2 secondary outcomes
survival rate or mortality rate
Time frame: 1 year, at 3-month interval
rehospitalization rate
Time frame: 1 year, at 3-month interval
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2019.
- Background: PubMed 2901440Ishikawa K. Diagnostic approach and proposed criteria for the clinical diagnosis of Takayasu's arteriopathy. J Am Coll Cardiol. 1988 Oct;12(4):964-72. doi: 10.1016/0735-1097(88)90462-7.
- Background: PubMed 1975175Arend WP, Michel BA, Bloch DA, Hunder GG, Calabrese LH, Edworthy SM, Fauci AS, Leavitt RY, Lie JT, Lightfoot RW Jr, et al. The American College of Rheumatology 1990 criteria for the classification of Takayasu arteritis. Arthritis Rheum. 1990 Aug;33(8):1129-34. doi: 10.1002/art.1780330811.
- Background: PubMed 25274886Yang L, Zhang H, Jiang X, Zou Y, Qin F, Song L, Guan T, Wu H, Xu L, Liu Y, Zhou X, Bian J, Hui R, Zheng D. Clinical manifestations and longterm outcome for patients with Takayasu arteritis in China. J Rheumatol. 2014 Dec;41(12):2439-46. doi: 10.3899/jrheum.140664. Epub 2014 Oct 1.
- Background: PubMed 9119516Sharma BK, Jain S, Suri S, Numano F. Diagnostic criteria for Takayasu arteritis. Int J Cardiol. 1996 Aug;54 Suppl:S141-7. doi: 10.1016/s0167-5273(96)88783-3.
- Derived from this study: PubMed 32702156Fan L, Yang L, Wei D, Ma W, Lou Y, Song L, Bian J, Zhang H, Cai J. Clinical Scenario and Long-Term Outcome of Childhood Takayasu Arteritis Undergoing 121 Endovascular Interventions: A Large Cohort Over a Fifteen-Year Period. Arthritis Care Res (Hoboken). 2021 Nov;73(11):1678-1688. doi: 10.1002/acr.24387. Epub 2021 Oct 13.
- Derived from this study: PubMed 31278892Fan L, Zhang H, Cai J, Yang L, Wei D, Yu J, Fan J, Song L, Ma W, Lou Y. Clinical Course, Management, and Outcomes of Pediatric Takayasu Arteritis Initially Presenting With Hypertension: A 16-year overview. Am J Hypertens. 2019 Sep 24;32(10):1021-1029. doi: 10.1093/ajh/hpz103.
- Derived from this study: PubMed 30670069Fan L, Zhang H, Cai J, Yang L, Liu B, Wei D, Yu J, Fan J, Song L, Ma W, Zhou X, Wu H, Lou Y. Clinical course and prognostic factors of childhood Takayasu's arteritis: over 15-year comprehensive analysis of 101 patients. Arthritis Res Ther. 2019 Jan 22;21(1):31. doi: 10.1186/s13075-018-1790-x.
- Individual participant dataSharing planned: Undecided. Consent for sharing of non identifiable study data for regulatory authorities.
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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.
Huimin Zhang, MD. principal investigator
Chinese Academy of Medical Sciences, Fuwai Hospital
Jun Cai, MD.PhD. principal investigator
Chinese Academy of Medical Sciences, Fuwai Hospital
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 Takayasu Arteritis, run by China National Center for Cardiovascular Diseases 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 4 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 25 Jan 2019. 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 Luyun Fan, MD. (01088398249, katevan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence rate (time frame: 1 year). 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 NCT03199183, which also lists 7 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 25 Jan 2019.