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

NCT ID: NCT06178419

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2025-07-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

RIC group

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

Group Type: EXPERIMENTAL

RIC

Intervention Type: 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 group

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

Group Type: SHAM_COMPARATOR

sham-RIC

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

sham-RIC

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: lead

Responsible Party

ZHAO YI, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yi Zhao, MD

Role: PRINCIPAL_INVESTIGATOR

Xuanwu Hospital, Capital Medical University, China, 10053

Sijie Li, MD

Role: PRINCIPAL_INVESTIGATOR

Xuanwu Hospital, Capital Medical University, China, 10053

Locations

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

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yi Zhao, MD

Role: CONTACT

zy85070@xwhosp.org

+8613811038669

Fang kong, MD

Role: CONTACT

kongfang90@163.com

+8613051116280

Facility Contacts

Yi Zhao, MD

Role: primary

18618360999

Other Identifiers

TARIC-1

Identifier Type: -

Identifier Source: org_study_id