An interventional study of RIC and sham-RIC in Cerebral Ischemia and Takayasu Arteritis, sponsored by Xuanwu Hospital, Beijing. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Xuanwu Hospital, Beijing · Not applicable, Interventional, and Prevention
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.
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.
217 studies on the registry are indexed under Brain Ischemia; 42 are open to participants now.
This study's planned enrollment of 44 is below the median of 73 across 140 interventional studies indexed under Brain Ischemia.
Browse Brain Ischemia studies →Xuanwu Hospital, Beijing is the lead sponsor of 363 studies on the registry; 230 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The RIC protocol includes five cycles of 5-min inflation to 200mmHg and 5-min deflation.
Device: RIC
The sham RIC protocol includes five cycles of 5-min inflation to 60mmHg and 5-min deflation.
Device: sham-RIC
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-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.
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.
Time frame: during baseline to 6 months after therapy
Incidence of major adverse cerebrovascular events ( MACE )
MACEs are defined as the occurrence of stroke, transient ischemic attacks (TIAs), blindness in patients.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: during baseline to 6months after therapy
Rate of the usage of glucocorticoids
The investigator will observe and record the usage of glucocorticoids.
Time frame: during baseline to 6months after therapy
Started Jan 2024 (actual). Primary completion is estimated for Jul 2025, 18 months after the start.
Of 43 interventional studies with no phase under Brain Ischemia, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 53. This study's planned 18 months is below that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.