Brief Summary

Chronic cerebral artery occlusion (CCAO), which is characterized by the pathophysiological change of long-term cerebral hemodynamic disorder, is one of the major risk factors affect the occurrence and recurrence of ischemic stroke. However, the mechanism of CCAO injury is not clear and effective treatment is warranted. The purpose of this study is to investigate the protective effect and underlying mechanism of remote ischemic conditioning (RIC) on CCAO.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

participants targeted

Target at below P25 for not_applicable

Timeline

Completed

Started Apr 2022

Geographic Reach

1 country

1 active site

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

11 months study duration

First Submitted

Initial submission to the registry

March 30, 2022

Completed

23 days until next milestone

Study Start

First participant enrolled

April 22, 2022

Completed

3 days until next milestone

First Posted

Study publicly available on registry

April 25, 2022

Completed

11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed

Last Updated

May 16, 2022

Status Verified

May 1, 2022

Enrollment Period

11 months

First QC Date

March 30, 2022

Last Update Submit

May 13, 2022

Conditions

Cerebral Artery Occlusion

Outcome Measures

Primary Outcomes (1)

Change of cerebral blood flow perfusion
The investigators evaluate the change of perfusion capacity of cerebral blood vessels on PWI-MRI.
180 days

Secondary Outcomes (11)

Recurrence times of stroke or transient ischemic attack (TIA)
180 days
Changes of volume of WMHs
180 days
Change of the direction of white matter cellulose
180 days
Change of cerebral hemoglobin oxygenation status
180 days
Change of collateral circulation
180 days
+6 more secondary outcomes

Other Outcomes (1)

Safety of RIC [Number of patients not tolerating RIC procedure and patients with erythema or skin lesions related to RIC]
180 days

Study Arms (2)

RIC group

EXPERIMENTAL

Participants in the experimental group receive both RIC and standard clinical therapy. The RIC treatment is composed of 5 cycles of bilateral upper limb ischemia for 5 minutes followed by reperfusion for another 5 minutes performed twice a day for a total of 180 consecutive days.The procedure was performed by using an electric autocontrol device with cuffs that inflated to a pressure of 200 mmHg during the ischemic period and deflated during the reperfusion (Patent No.CN200820123637.X, China).

Device: Remote ischemic conditioning

Control group

NO INTERVENTION

Participants in the control group receive standard clinical therapy.

Interventions

Remote ischemic conditioningDEVICE

The LRIC treatment consisted of 5 cycles of bilateral upper limb ischemia for 5 minutes followed by reperfusion for another 5 minutes performed twice a day for a total of 180 consecutive days.The procedure was performed by using an electric autocontrol device with cuffs that inflated to a pressure of 200 mmHg during the ischemic period and deflated during the reperfusion.(Patent No.CN200820123637.X, China).

RIC group

Eligibility Criteria

Age40 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

(1) Age range 40-80 years, regardless of gender;
(2) Digital angiography (DSA) / ultrasound / CT angiography (CTA) / magnetic resonance angiography (MRA) showed unilateral internal carotid artery (ICA) or middle cerebral artery (MCA) occlusion and stenosis of any other cerebral arteries (e.g. the other side of ICA or MCA, basilar artery) \< 50%;
(3) Modified Rankin Scale (mRS) score 0-2;
(4) Symptoms of ischemic cerebrovascular disease (ischemic stroke or TIA) due to ICA or MCA occlusions within 12 months prior to enrollment;
(5) neurological deficits were stable ≥ 30 days after occlusion;
(6) Magnetic resonance perfusion weighted imaging (PWI) showed mean transit time (MTT) ≥ 4s and related cerebral blood flow (rCBF) (symptomatic side/asymptomatic side) \< 0.95;
(7) The subject or its legally authorized representative is able to provide informed reports.

You may not qualify if:

(1) Uncontrolled hypertension despite the use of antihypertensive drugs before enrollment (defined as systolic blood pressure ≥200mmHg);
(2) Stenosis or occlusion of subclavian artery and upper limb artery;
(3) Previous history of cerebral hemorrhage, including intracranial hemorrhage, ischemic stroke hemorrhage transformation, vascular malformation or intracranial tumor or other parts of the active bleeding disease;
(4) History of brain tumor or mental illness or acute stroke ≤6 months;
(5) Suffering from cardiogenic thrombosis diseases, such as mitral stenosis and atrial fibrillation, myocardial infarction, mural thrombosis or valvular vegetations, congestive heart failure or endocarditis within six months;
(6) Obvious disorder of coagulation mechanism;
(7) Severe liver or kidney insufficiency, malignant tumor, or serious diseases requiring medical intervention or surgery;
(8) There is soft tissue or blood vessel injury at the cuff compression site of RIC treatment, or other conditions that cannot tolerate RIC;
(9) Pregnant or lactating women;
(10) Life expectancy \<6 months;
(11) Refusal to sign informed consent, poor compliance, or inability to complete complete treatment, etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Capital Medical Universitylead

Study Sites (1)

Xuanwu Hospital Capital Medical University

Beijing, China

RECRUITING

Related Publications (2)

Meng R, Asmaro K, Meng L, Liu Y, Ma C, Xi C, Li G, Ren C, Luo Y, Ling F, Jia J, Hua Y, Wang X, Ding Y, Lo EH, Ji X. Upper limb ischemic preconditioning prevents recurrent stroke in intracranial arterial stenosis. Neurology. 2012 Oct 30;79(18):1853-61. doi: 10.1212/WNL.0b013e318271f76a. Epub 2012 Oct 3.
PMID: 23035060RESULT
Wang Y, Meng R, Song H, Liu G, Hua Y, Cui D, Zheng L, Feng W, Liebeskind DS, Fisher M, Ji X. Remote Ischemic Conditioning May Improve Outcomes of Patients With Cerebral Small-Vessel Disease. Stroke. 2017 Nov;48(11):3064-3072. doi: 10.1161/STROKEAHA.117.017691. Epub 2017 Oct 17.
PMID: 29042490RESULT

Study Officials

Xunming Ji, MD.PhD
Xuanwu Hospital, Beijing
PRINCIPAL INVESTIGATOR

Central Study Contacts

Xunming Ji, MD.PhD

CONTACT

010-83199430 jixm@ccmu.edu.cn

Hongrui Ma, MD

CONTACT

17319359172 beif1995@163.com

Study Design

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

Study Record Dates

First Submitted

March 30, 2022

First Posted

April 25, 2022

Study Start

April 22, 2022

Primary Completion

March 31, 2023

Study Completion

March 31, 2023

Last Updated

May 16, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing: Will not share

Locations

CN(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (11)

Other Outcomes (1)

Study Arms (2)

RIC group

Control group

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (2)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Locations