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

September 12, 2024 updated by: ZHAO YI, MD, Xuanwu Hospital, Beijing

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100053
        • Recruiting
        • Department of Rheumatology and Allergy, Xuanwu Hospital, Capital Medical University, Beijing, China
        • Contact:
          • Yi Zhao, MD
          • Phone Number: 18618360999

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: RIC group
The RIC protocol includes five cycles of 5-min inflation to 200mmHg and 5-min deflation.
Device: 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 Comparator: sham RIC group
The sham RIC protocol includes five cycles of 5-min inflation to 60mmHg and 5-min deflation.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
during baseline to 6 months after therapy

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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 change value of arterial transit time ( ATT ) in pCASL hypoperfusion area compared with baseline
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
Professional doctors will check it and the investigator will record the number.
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
Professional doctors will definite whether there's a palpation for tenderness and record the number.
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 investigator will record the number.
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
The investigator will record the number.
during baseline to 6months after therapy
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.
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 blood pressure (BP) will be compared with baseline
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 erythrocyte sedimentation rate (ESR) will be compared with baseline
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 protein (CRP) will be compared with baseline
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 interleukin 6 (IL-6) will be compared with baseline
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 values of serum level of vascular endothelial growth factor (VEGF) will be compared with baseline.
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 nerve growth factor (NGF) will be compared with baseline.
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 endothelin-1 (ET-1) will be compared with baseline.
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 angiotensin converting enzyme (ACE) will be compared with baseline.
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 activating factor (PAF) will be compared with baseline.
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 serum level of platelet growth factor ( PDGF ) will be compared with baseline.
during baseline to 6months after therapy
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.
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 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.
during baseline to 6months after therapy
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.
during baseline to 6months after therapy
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.
during baseline to 6months after therapy
Rate of the usage of glucocorticoids
Time Frame: during baseline to 6months after therapy
The investigator will observe and record the usage of glucocorticoids.
during baseline to 6months after therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xuanwu Hospital, Beijing

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yi Zhao, MD, Xuanwu Hospital, Capital Medical University, China, 10053
  • Principal Investigator: Sijie Li, MD, Xuanwu Hospital, Capital Medical University, China, 10053

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 21, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 21, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 19, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TARIC-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings