Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Control group | No Intervention | Participants in the control group receive standard clinical therapy. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote ischemic conditioning | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Change of cerebral blood flow perfusion | The investigators evaluate the change of perfusion capacity of cerebral blood vessels on PWI-MRI. | 180 days |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence times of stroke or transient ischemic attack (TIA) | The investigators evaluate the times of stroke or transient ischemic attack (TIA) recurrence. | 180 days |
| Changes of volume of WMHs |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xunming Ji, MD.PhD | Contact | 010-83199430 | jixm@ccmu.edu.cn | |
| Hongrui Ma, MD | Contact | 17319359172 | beif1995@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xunming Ji, MD.PhD | Xuanwu Hospital, Beijing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital Capital Medical University | Recruiting | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23035060 | Result | 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. | |
| 29042490 | Result |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
The investigators evaluate the the change of volume of WMHs on Flairs-MRI.
| 180 days |
| Change of the direction of white matter cellulose | The investigators evaluate the change of direction of white matter cellulose on DTI-MRI. | 180 days |
| Change of cerebral hemoglobin oxygenation status | The investigators evaluate the change of cerebral hemoglobin oxygenation status on BOLD-rsfMRI. | 180 days |
| Change of collateral circulation | The investigators evaluate the change of collateral circulation on ASL-MRI. | 180 days |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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. |