Cerebral IschemiaTARIC-1NCT06178419
Remote Ischemic Conditioning for Cerebral Ischemia in Patients With Takayasu Arteritis (TARIC-1)
A study testing RIC in people with Cerebral Ischemia and Takayasu Arteritis, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
The aim of this study is to evaluate the safety and efficacy of remote ischemic conditioning ( RIC ) in the protection of cerebral ischemia in patients with Takayasu arteritis ( TAK ). The study was designed as a prospective, double-blind, exploratory randomized controlled study. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cerebral Ischemia, Takayasu Arteritis
- What is being tested?
- RIC
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 31 Jul 2025
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients fulfilled the 1990 American College of Rheumatology Classification Criteria for TAK
- Inactive state
- Male and female, aged 18-65 years old
- The presence of supra-aortic vascular involvement ( including but not limited to the left and right sides of the common carotid artery, subclavian artery, vertebral artery involvement )
- Decreased cerebral blood perfusion in the whole brain ( compared with healthy people ) or local ( left and right brain contrast ) suggested by pseudo-Continuous arterial spin labeling ( pCASL ) -MRI
- Voluntary participation in this study, signed informed consent
Who cannot join
- Complications that endanger the function of important organs, such as uncontrollable heart failure, severe heart valve disease, severe hypertension, severe myocardial ischemia, pulmonary hypertension, acute cerebral infarction, arterial dissection or aneurysm rupture, etc
- There are serious complications, such as poorly controlled diabetes, renal insufficiency, cardiopulmonary insufficiency, mental illness or malignant tumor
- There were moderate to severe stenosis of brachial artery in both upper limbs
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Rheumatology and Allergy, Xuanwu Hospital, Capital Medical University, Beijing, China
Beijing, Beijing Municipality, 100053
Yi Zhao, MD, 18618360999
About this study
Official title: Safety and Efficacy of Remote Ischemic Conditioning for Cerebral Ischemia in Patients With Takayasu Arteritis: a Prospective Cohort Study
The aim of this study is to evaluate the safety and efficacy of remote ischemic conditioning ( RIC ) in the protection of cerebral ischemia in patients with Takayasu arteritis ( TAK ). The study was designed as a prospective, double-blind, exploratory randomized controlled study. The entire study included a screening period and a treatment observation period ( a total of 24 weeks ). All patients with cerebral ischemia of TAK will be randomly divided into RIC group and sham RIC group at 1:1 ratio. On the basis of receiving the conventional drug therapy, the patients will be treated with RIC or sham RIC treatment twice daily for six month. The clinical data of patients at baseline and each follow-up will be collected, including basic information, disease activity assessment, laboratory indicators, imaging indicators, treatment data, adverse events, etc.The Primary outcome is the mean cerebral blood flow improvement rate ( mCBF-IR ) of TAK patients after 24 weeks-treatment. Secondary endpoints include the incidence of major adverse cerebrovascular events ( MACE ) , the change value of arterial transit time ( ATT ) in pCASL hypoperfusion area compared with baseline, occurrence of RIC-related adverse reactions, the changes of hematological indexes and disease activity score, etc. This study will provide insights into the preliminary proof of principle, safety, and efficacy of RIC in cerebral ischemia in patients with Takayasu arteritis ( TAK ), and this data will provide parameters for future larger scale clinical trials if efficacious.
Read the detailed description
Clinical symptoms, routine follow-up laboratory tests, other serological indicators (VEGF, NGF, ET-1, ACE), PAF, PDGF, etc.), vascular involvement, cranial MRI, vascular injury score, disease activity and treatment will be collected at baseline. After RIC or sham RIC intervention, clinical symptoms, laboratory tests, disease activity, treatment and RIC-related adverse reactions will be collected at 1m, 2m,3m and 6m. the data of vascular involvement, cranial MRI, vascular injury score and disease activity will also be collected at 6 months follow-up.
- Conditions
- Cerebral Ischemia, Takayasu Arteritis
- Being tested
- RIC, sham-RIC
- Keywords
- Cerebral Ischemia, Takayasu Arteritis, remote ischemic conditioning
- Medical subject headings
- Brain Ischemia, Takayasu Arteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RICDevice
RIC is a non-invasive therapy that is performed by automated pneumatic cuffs placed on unilateral arms. The RIC protocol includes five cycles of 5-min inflation to 200mmHg and 5-min deflation.
sham-RICDevice
Sham-RIC is a non-invasive therapy that is performed by automated pneumatic cuffs placed on unilateral arms. The sham RIC protocol includes five cycles of 5-min inflation to 60mmHg and 5-min deflation.
| Study group | Role | What they receive |
|---|---|---|
| RIC group | Experimental | The RIC protocol includes five cycles of 5-min inflation to 200mmHg and 5-min deflation. Receives: Device: RIC |
| sham RIC group | Sham comparator | The sham RIC protocol includes five cycles of 5-min inflation to 60mmHg and 5-min deflation. Receives: Device: sham-RIC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean cerebral blood flow improvement rate
Mean cerebral blood flow improvement rate ( mCBF-IR ) of TAK patients will be obtained by pseudo-continuous arterial spin labeling ( pCASL ) -MRI.
Measured: during baseline to 6 months after therapy
Secondary outcomes (22)
Incidence of major adverse cerebrovascular events ( MACE )
MACEs are defined as the occurrence of stroke, transient ischemic attacks (TIAs), blindness in patients.
Measured: during baseline to 6 months after therapy
The change value of arterial transit time ( ATT )
The change value of arterial transit time ( ATT ) in pCASL hypoperfusion area compared with baseline
Measured: during baseline to 6 months after therapy
The number of patients with erythema,and/or skin lesions related to RIC
Professional doctors will check it and the investigator will record the number.
Measured: during baseline to 6 months after therapy
The number of patients with palpation for tenderness related to RIC
Professional doctors will definite whether there's a palpation for tenderness and record the number.
Measured: during baseline to 6 months after therapy
The number of patients not tolerating RIC procedure,and refuse to continue the RIC procedure
The investigator will record the number.
Measured: during baseline to 6 months after therapy
The number of patients with any other adverse events related to RIC intervention
The investigator will record the number.
Measured: during baseline to 6months after therapy
Incidence of clinical symptoms
The investigator will observe and record the occurrence of the clinical symptoms of dizziness, limb claudication, pulse deficits, bruits, headache, neck pain, severe abdominal pain, hypertension, valvular insufficiency, arrhythmia, chest pain or dsypnea.
Measured: during baseline to 1, 2, 3, 6months after therapy
The change value of blood pressure (BP)
The change value of blood pressure (BP) will be compared with baseline
Measured: during baseline to 1, 2, 3, 6months after therapy
The change value of erythrocyte sedimentation rate (ESR)
The change value of erythrocyte sedimentation rate (ESR) will be compared with baseline
Measured: during baseline to 1, 2, 3, 6months after therapy
The change value of C reactive protein (CRP)
The change value of C reactive protein (CRP) will be compared with baseline
Measured: during baseline to 1, 2, 3, 6months after therapy
The change value of C reactive proteininterleukin 6 (IL-6)
The change value of interleukin 6 (IL-6) will be compared with baseline
Measured: during baseline to 1, 2, 3, 6months after therapy
The change value of serum level of vascular endothelial growth factor (VEGF)
The change values of serum level of vascular endothelial growth factor (VEGF) will be compared with baseline.
Measured: during baseline to 6months after therapy
The change value of serum level of nerve growth factor (NGF)
The change value of serum level of nerve growth factor (NGF) will be compared with baseline.
Measured: during baseline to 6months after therapy
The change value of serum level of endothelin-1 (ET-1)
The change value of serum level of endothelin-1 (ET-1) will be compared with baseline.
Measured: during baseline to 6months after therapy
The change value of serum level of angiotensin converting enzyme (ACE)
The change value of serum level of angiotensin converting enzyme (ACE) will be compared with baseline.
Measured: during baseline to 6months after therapy
The change value of serum level of platelet activating factor (PAF)
The change value of serum level of platelet activating factor (PAF) will be compared with baseline.
Measured: during baseline to 6months after therapy
The change value of serum level of platelet growth factor ( PDGF )
The change value of serum level of platelet growth factor ( PDGF ) will be compared with baseline.
Measured: during baseline to 6months after therapy
The change value of Birmingham Vasculitis Activity Score (BVAS)
The investigator will record the score. The BVAS is the most effective validated tool to document disease activity, ranging from 0 to 63. A score greater than or equal to 15 indicates that the disease is active. The higher score means the higher disease activity and a worse outcome.
Measured: during baseline to 6months after therapy
The change value of the Indian Takayasu Clinical Activity Score (ITAS) 2010
The investigator will record the score. ITAS 2010, a useful measure of clinical disease activity, ranges from 0 to 51 points. A score greater than or equal to 2 indicates that the disease is active. The higher score means the higher disease activity and the worse outcome.
Measured: during baseline to 6months after therapy
The change value of the Vasculitis Damage Index (VDI)
Disease damage will be evaluated using the Vasculitis Damage Index (VDI). It ranges from 0 to 64 points. The higher score means the more severe vascular damage and the worse outcome.
Measured: during baseline to 6months after therapy
The change value of the number of affected blood vessels
The number of affected blood vessels will be performed by Doppler US, CT angiography, magnetic resonance angiography (MRA), or digital subtraction angiography. The change value of the number will be compared with baseline.
Measured: during baseline to 6months after therapy
Rate of the usage of glucocorticoids
The investigator will observe and record the usage of glucocorticoids.
Measured: during baseline to 6months after therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2023
- Study start1 Jan 2024
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 2025 (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 Cerebral IschemiaStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ZHAO YI, MD, Xuanwu Hospital, Beijing
- Investigators
- Yi Zhao, MD, Principal investigator, Xuanwu Hospital, Capital Medical University, China, 10053Sijie Li, MD, Principal investigator, Xuanwu Hospital, Capital Medical University, China, 10053
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06178419
- Sponsor's protocol ID
- TARIC-1
- Acronym
- TARIC-1
- Status last verified
- Sep 2024
- First submitted
- 21 Nov 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Huang S, Kong F, Zhao W, Ren C, Elmadhoun O, Ding Y, Ji X, Zhao Y, Li S. Remote ischemic conditioning for cerebral ischemia in patients with Takayasu arteritis (TARIC-1): Study protocol. Brain Circ. 2026 Jan 12;12(2):118-123. doi: 10.4103/bc.bc_162_24. eCollection 2026 Apr-Jun.
PubMed 42111310
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Remote Ischemic Conditioning for Cerebral Ischemia in Patients With Takayasu Arteritis: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06178419
- Acronym / sponsor ID
- TARIC-1 / TARIC-1
- Conditions
- Cerebral Ischemia, Takayasu Arteritis
- Keywords
- Cerebral Ischemia, Takayasu Arteritis, remote ischemic conditioning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 21 Dec 2023 (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.
The aim of this study is to evaluate the safety and efficacy of remote ischemic conditioning ( RIC ) in the protection of cerebral ischemia in patients with Takayasu arteritis ( TAK ). The study was designed as a prospective, double-blind, exploratory randomized controlled study. The entire study included a screening period and a treatment observation period ( a total of 24 weeks ). All patients with cerebral ischemia of TAK will be randomly divided into RIC group and sham RIC group at 1:1 ratio. On the basis of receiving the conventional drug therapy, the patients will be treated with RIC or sham RIC treatment twice daily for six month. The clinical data of patients at baseline and each follow-up will be collected, including basic information, disease activity assessment, laboratory indicators, imaging indicators, treatment data, adverse events, etc.The Primary outcome is the mean cerebral blood flow improvement rate ( mCBF-IR ) of TAK patients after 24 weeks-treatment. Secondary endpoints include the incidence of major adverse cerebrovascular events ( MACE ) , the change value of arterial transit time ( ATT ) in pCASL hypoperfusion area compared with baseline, occurrence of RIC-related adverse reactions, the changes of hematological indexes and disease activity score, etc. This study will provide insights into the preliminary proof of principle, safety, and efficacy of RIC in cerebral ischemia in patients with Takayasu arteritis ( TAK ), and this data will provide parameters for future larger scale clinical trials if efficacious.
Detailed description
Clinical symptoms, routine follow-up laboratory tests, other serological indicators (VEGF, NGF, ET-1, ACE), PAF, PDGF, etc.), vascular involvement, cranial MRI, vascular injury score, disease activity and treatment will be collected at baseline. After RIC or sham RIC intervention, clinical symptoms, laboratory tests, disease activity, treatment and RIC-related adverse reactions will be collected at 1m, 2m,3m and 6m. the data of vascular involvement, cranial MRI, vascular injury score and disease activity will also be collected at 6 months follow-up.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RIC group | Experimental | Device: RICThe RIC protocol includes five cycles of 5-min inflation to 200mmHg and 5-min deflation. |
| sham RIC group | Sham comparator | Device: sham-RICThe sham RIC protocol includes five cycles of 5-min inflation to 60mmHg and 5-min deflation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- All patients fulfilled the 1990 American College of Rheumatology Classification Criteria for TAK
- Inactive state
- Male and female, aged 18-65 years old
- The presence of supra-aortic vascular involvement ( including but not limited to the left and right sides of the common carotid artery, subclavian artery, vertebral artery involvement )
- Decreased cerebral blood perfusion in the whole brain ( compared with healthy people ) or local ( left and right brain contrast ) suggested by pseudo-Continuous arterial spin labeling ( pCASL ) -MRI
Key exclusion criteria (3 listed)
- Complications that endanger the function of important organs, such as uncontrollable heart failure, severe heart valve disease, severe hypertension, severe myocardial ischemia, pulmonary hypertension, acute cerebral infarction, arterial dissection or aneurysm rupture, etc
- There are serious complications, such as poorly controlled diabetes, renal insufficiency, cardiopulmonary insufficiency, mental illness or malignant tumor
- There were moderate to severe stenosis of brachial artery in both upper limbs
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 |
|---|---|---|
| RICRIC is a non-invasive therapy that is performed by automated pneumatic cuffs placed on unilateral arms. The RIC protocol includes five cycles of 5-min inflation to 200mmHg and 5-min deflation. | Device | RIC group |
| sham-RICSham-RIC is a non-invasive therapy that is performed by automated pneumatic cuffs placed on unilateral arms. The sham RIC protocol includes five cycles of 5-min inflation to 60mmHg and 5-min deflation. | Device | sham RIC group |
Primary outcome
Mean cerebral blood flow improvement rate
Time frame: during baseline to 6 months after therapy
Mean cerebral blood flow improvement rate ( mCBF-IR ) of TAK patients will be obtained by pseudo-continuous arterial spin labeling ( pCASL ) -MRI.
22 secondary outcomes
Incidence of major adverse cerebrovascular events ( MACE )
Time frame: during baseline to 6 months after therapy
The change value of arterial transit time ( ATT )
Time frame: during baseline to 6 months after therapy
The number of patients with erythema,and/or skin lesions related to RIC
Time frame: during baseline to 6 months after therapy
The number of patients with palpation for tenderness related to RIC
Time frame: during baseline to 6 months after therapy
The number of patients not tolerating RIC procedure,and refuse to continue the RIC procedure
Time frame: during baseline to 6 months after therapy
The number of patients with any other adverse events related to RIC intervention
Time frame: during baseline to 6months after therapy
Incidence of clinical symptoms
Time frame: during baseline to 1, 2, 3, 6months after therapy
The change value of blood pressure (BP)
Time frame: during baseline to 1, 2, 3, 6months after therapy
The change value of erythrocyte sedimentation rate (ESR)
Time frame: during baseline to 1, 2, 3, 6months after therapy
The change value of C reactive protein (CRP)
Time frame: during baseline to 1, 2, 3, 6months after therapy
The change value of C reactive proteininterleukin 6 (IL-6)
Time frame: during baseline to 1, 2, 3, 6months after therapy
The change value of serum level of vascular endothelial growth factor (VEGF)
Time frame: during baseline to 6months after therapy
The change value of serum level of nerve growth factor (NGF)
Time frame: during baseline to 6months after therapy
The change value of serum level of endothelin-1 (ET-1)
Time frame: during baseline to 6months after therapy
The change value of serum level of angiotensin converting enzyme (ACE)
Time frame: during baseline to 6months after therapy
The change value of serum level of platelet activating factor (PAF)
Time frame: during baseline to 6months after therapy
The change value of serum level of platelet growth factor ( PDGF )
Time frame: during baseline to 6months after therapy
The change value of Birmingham Vasculitis Activity Score (BVAS)
Time frame: during baseline to 6months after therapy
The change value of the Indian Takayasu Clinical Activity Score (ITAS) 2010
Time frame: during baseline to 6months after therapy
The change value of the Vasculitis Damage Index (VDI)
Time frame: during baseline to 6months after therapy
The change value of the number of affected blood vessels
Time frame: during baseline to 6months after therapy
Rate of the usage of glucocorticoids
Time frame: during baseline to 6months after therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 42111310Huang S, Kong F, Zhao W, Ren C, Elmadhoun O, Ding Y, Ji X, Zhao Y, Li S. Remote ischemic conditioning for cerebral ischemia in patients with Takayasu arteritis (TARIC-1): Study protocol. Brain Circ. 2026 Jan 12;12(2):118-123. doi: 10.4103/bc.bc_162_24. eCollection 2026 Apr-Jun.
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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.
Yi Zhao, MD principal investigator
Xuanwu Hospital, Capital Medical University, China, 10053
Sijie Li, MD principal investigator
Xuanwu Hospital, Capital Medical University, China, 10053
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RIC in people with Cerebral Ischemia and Takayasu Arteritis, run by Xuanwu Hospital, Beijing 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 6 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 19 Sep 2024. 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. Some participants in this study may receive a placebo. 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 Yi Zhao, MD (+8613811038669, zy85070@xwhosp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean cerebral blood flow improvement rate (time frame: during baseline to 6 months after therapy). 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 NCT06178419, 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 19 Sep 2024.