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

NCT06178419 | Recruiting

• 1 other identifier: TARIC-1
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cerebral Ischemia; Takayasu Arteritis

Keywords

Cerebral Ischemia; Takayasu Arteritis; remote ischemic conditioning

Outcome Measures

Primary Outcomes (1)

• 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.

  during baseline to 6 months after therapy

Secondary Outcomes (22)

• Incidence of major adverse cerebrovascular events ( MACE )

  during baseline to 6 months after therapy

• The change value of arterial transit time ( ATT )

  during baseline to 6 months after therapy

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

  during baseline to 6 months after therapy

• The number of patients with palpation for tenderness related to RIC

  during baseline to 6 months after therapy

• The number of patients not tolerating RIC procedure,and refuse to continue the RIC procedure

  during baseline to 6 months after therapy

Study Arms (2)

RIC group

EXPERIMENTAL

The RIC protocol includes five cycles of 5-min inflation to 200mmHg and 5-min deflation.

Device: RIC

sham RIC group

SHAM COMPARATOR

The sham RIC protocol includes five cycles of 5-min inflation to 60mmHg and 5-min deflation.

Device: sham-RIC

Interventions

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.

RIC group

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.

sham RIC group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

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

Beijing, Beijing Municipality, 100053, China

RECRUITING

MeSH Terms

Conditions

Brain Ischemia; Takayasu Arteritis

Condition Hierarchy (Ancestors)

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

Study Officials

• Yi Zhao, MD

  Xuanwu Hospital, Capital Medical University, China, 10053

  PRINCIPAL INVESTIGATOR

• Sijie Li, MD

  Xuanwu Hospital, Capital Medical University, China, 10053

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi Zhao, MD

CONTACT

+8613811038669; zy85070@xwhosp.org

Fang kong, MD

CONTACT

+8613051116280; kongfang90@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: December 21, 2023
• Study Start: January 1, 2024
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

CN (1)