Remote Ischemic Conditioning for Chronic Cerebral Artery Occlusion

Cerebral Artery Occlusion Clinical Trial

Official title:

Safety and Efficacy of Remote Ischemic Conditioning in Patients With Chronic Cerebral Artery Occlusion: A Prospective, Randomized, Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05342714
• Other study ID #: RIC-CCAO
• Status: Recruiting
• Phase: N/A
• Start date: April 22, 2022
• Est. completion date: March 31, 2023

Study information

• Verified date: May 2022
• Source: Capital Medical University
• Contact: Xunming Ji, MD.PhD
• Phone: 010-83199430
• Email: jixm[@]ccmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

CCAO is a cerebrovascular disease due to cerebral hypo-perfusion. It is often associated with repeated ischemic stroke or transient neurological symptoms, progressive cognitive decline and reduction of daily ability. Specific and effective treatment is warranted for symptomatic management of CCAO. RIC is a non-invasive strategy to protect the brain. The clinical trials have demonstrated that daily limb RIC seems to be potentially effective in patients with symptomatic intracranial arterial stenosis in cerebral blood flow and metabolism. RIC can also ameliorate cerebral small vessel disease in slowing cognition decline and reducing white matter. Therefore, it is worth to investigate the neuroprotective mechanism of RIC for CCAO.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• (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.

Exclusion Criteria:

• (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.

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Cerebral Artery Occlusion

Intervention

Device:
• Remote ischemic conditioning
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).

Locations

Country	Name	City	State
China	Xuanwu Hospital Capital Medical University	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

References & 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 — View Citation

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.117.01 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety of RIC [Number of patients not tolerating RIC procedure and patients with erythema or skin lesions related to RIC]	The safety of RIC by the number of patients not tolerating RIC procedure and patients with erythema or skin lesions related to RIC.	180 days
Primary	Change of cerebral blood flow perfusion	The investigators evaluate the change of perfusion capacity of cerebral blood vessels on PWI-MRI.	180 days
Secondary	Recurrence times of stroke or transient ischemic attack (TIA)	The investigators evaluate the times of stroke or transient ischemic attack (TIA) recurrence.	180 days
Secondary	Changes of volume of WMHs	The investigators evaluate the the change of volume of WMHs on Flairs-MRI.	180 days
Secondary	Change of the direction of white matter cellulose	The investigators evaluate the change of direction of white matter cellulose on DTI-MRI.	180 days
Secondary	Change of cerebral hemoglobin oxygenation status	The investigators evaluate the change of cerebral hemoglobin oxygenation status on BOLD-rsfMRI.	180 days
Secondary	Change of collateral circulation	The investigators evaluate the change of collateral circulation on ASL-MRI.	180 days
Secondary	Change of the Montreal Cognitive Assessment (MoCA) score	The investigators evaluate the change of neurobehavioral function by the Montreal Cognitive Assessment (MoCA) score. The minimum value is 0 and maximum value is 30. The higher scores represent the better outcome.	180 days
Secondary	Change of the Verbal Fluency Test (VFT) score	The investigators evaluate the change of neurobehavioral function by the Verbal Fluency Test (VFT) score. The minimum value is 0 and without the maximum value. The higher scores represent the better outcome.	180 days
Secondary	Change of the Digit Span Forward and Backward score	The investigators evaluate the change of neurobehavioral function by the Digit Span Forward and Backward score. The minimum value is 3 and maximum value is 12. The higher scores represent the better outcome.	180 days
Secondary	Change of the Hamilton Depression-17 (HAMD-17) scale	The investigators evaluate the change of neuropsychological function by the Hamilton Depression-17 (HAMD-17) scale. The minimum value is 0 and maximum value is 54. The higher scores represent the worse outcome.	180 days
Secondary	Change of the Hamilton Anxiety (HAMA) scale	The investigators evaluate the change of neuropsychological function by the Hamilton Anxiety (HAMA) scale. The minimum value is 0 and maximum value is 56. The higher scores represent the worse outcome.	180 days
Secondary	Adverse events related to RIC treatment	Adverse events related to RIC treatment, such as mucocutaneous hemorrhage, changes in coagulation function and so on.	From baseline to 180-day treatment