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NCT Number: NCT06178419

Remote Ischemic Conditioning for Cerebral Ischemia in Patients With Takayasu Arteritis (TARIC-1)

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.

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Key information

Conditions

Cerebral Ischemia Aortic Arch Syndromes Aortic Diseases Arteritis Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Takayasu Arteritis Vascular Diseases Vasculitis

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Rheumatology and Allergy, Xuanwu Hospital, Capital Medical University, Beijing, China

Beijing, Beijing Municipality, 100053, China

Location status: Recruiting

Location contact

Yi Zhao, MD

CONTACT

18618360999

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

RIC

Device

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

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Incidence of major adverse cerebrovascular events ( MACE )

    Time frame: during baseline to 6 months after therapy

    MACEs are defined as the occurrence of stroke, transient ischemic attacks (TIAs), blindness in patients.

  2. The change value of arterial transit time ( ATT )

    Time frame: during baseline to 6 months after therapy

    The change value of arterial transit time ( ATT ) in pCASL hypoperfusion area compared with baseline

  3. The number of patients with erythema,and/or skin lesions related to RIC

    Time frame: during baseline to 6 months after therapy

    Professional doctors will check it and the investigator will record the number.

  4. The number of patients with palpation for tenderness related to RIC

    Time frame: during baseline to 6 months after therapy

    Professional doctors will definite whether there's a palpation for tenderness and record the number.

  5. 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 investigator will record the number.

  6. The number of patients with any other adverse events related to RIC intervention

    Time frame: during baseline to 6months after therapy

    The investigator will record the number.

  7. Incidence of clinical symptoms

    Time frame: during baseline to 1, 2, 3, 6months after therapy

    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.

  8. The change value of blood pressure (BP)

    Time frame: during baseline to 1, 2, 3, 6months after therapy

    The change value of blood pressure (BP) will be compared with baseline

  9. The change value of erythrocyte sedimentation rate (ESR)

    Time frame: during baseline to 1, 2, 3, 6months after therapy

    The change value of erythrocyte sedimentation rate (ESR) will be compared with baseline

  10. 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 protein (CRP) will be compared with baseline

  11. 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 interleukin 6 (IL-6) will be compared with baseline

  12. The change value of serum level of vascular endothelial growth factor (VEGF)

    Time frame: during baseline to 6months after therapy

    The change values of serum level of vascular endothelial growth factor (VEGF) will be compared with baseline.

  13. 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 nerve growth factor (NGF) will be compared with baseline.

  14. 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 endothelin-1 (ET-1) will be compared with baseline.

  15. 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 angiotensin converting enzyme (ACE) will be compared with baseline.

  16. 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 activating factor (PAF) will be compared with baseline.

  17. The change value of serum level of platelet growth factor ( PDGF )

    Time frame: during baseline to 6months after therapy

    The change value of serum level of platelet growth factor ( PDGF ) will be compared with baseline.

  18. The change value of Birmingham Vasculitis Activity Score (BVAS)

    Time frame: during baseline to 6months after therapy

    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.

  19. The change value of the Indian Takayasu Clinical Activity Score (ITAS) 2010

    Time frame: during baseline to 6months after therapy

    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.

  20. The change value of the Vasculitis Damage Index (VDI)

    Time frame: during baseline to 6months after therapy

    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.

  21. The change value of the number of affected blood vessels

    Time frame: during baseline to 6months after therapy

    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.

  22. Rate of the usage of glucocorticoids

    Time frame: during baseline to 6months after therapy

    The investigator will observe and record the usage of glucocorticoids.

Study contacts

Contact information is provided by the study sponsor or research team.

Fang kong, MD

CONTACT

[email protected]

+8613051116280

Yi Zhao, MD

CONTACT

[email protected]

+8613811038669

Sponsors and collaborators

Lead sponsor

Xuanwu Hospital, Beijing

Other

Registry information

Official study title

Safety and Efficacy of Remote Ischemic Conditioning for Cerebral Ischemia in Patients With Takayasu Arteritis: a Prospective Cohort Study

Acronym: TARIC-1

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 21, 2023
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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