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Cerebral amyloid angiopathy (CAA) is a common form of cerebral small vessel disease, characterized by symptomatic intracerebral hemorrhage and cognitive impairment. However, no effective prevention and treatment strategies have been established. This study aims to evaluate the safety and efficacy of remote ischemic conditioning on patients with CAA.
CAA is a cerebrovascular disease caused by the deposition of β-amyloid in the walls of arteries, arterioles, and capillaries in the cerebral cortex and overlying leptomeninges. It is often associated with repeated lobar intracerebral hemorrhages, progressive cognitive decline, transient neurological symptoms and gait disturbances. No treatment is specific for symptomatic management of CAA up to date. Remote ischemic conditioning 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 cerebral small-vessel disease in slowing cognition decline and reducing white matter hyperintensities. Thereby, investigators design this study to assess whether RIC has a beneficial effect on CAA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RIC group | Experimental | RIC treatment and regular treatment. |
|
| Regular treatment | No Intervention | Regular treatment alone. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote ischemic conditioning | Device | RIC is a non-invasive therapy that performed by an electric auto-control device with cuff placed on arm. RIC procedures consist of five cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuff on one arm. The procedure will be performed twice daily for consecutive 1 years after enrollment. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of volume of WMHs. | The volume of WMHs was measured on Flairs at 6months and 12months. | From baseline to 6 months and 1 year treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 6 months and 1 year treatment. |
| Incidence of cardio-cerebral vascular events. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xunming Ji, MD PhD | Contact | 010-83199430 | jixm@ccmu.edu.cn | |
| Mengke Zhang, MD | Contact | zwzmk985@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Xunming Ji, MD PhD | Xuanwu Hospital, Beijing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuan Wu Hospital,Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100069 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29042490 | Background | 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. | |
| 31105769 | Background | Chen SJ, Tsai HH, Tsai LK, Tang SC, Lee BC, Liu HM, Yen RF, Jeng JS. Advances in cerebral amyloid angiopathy imaging. Ther Adv Neurol Disord. 2019 May 3;12:1756286419844113. doi: 10.1177/1756286419844113. eCollection 2019. |
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| ID | Term |
|---|---|
| D016657 | Cerebral Amyloid Angiopathy |
| ID | Term |
|---|---|
| D002539 | Cerebral Arterial Diseases |
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
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Incidence of cardiovascular and cerebrovascular events,such as Intracranial hemorrhage, subarachnoid hemorrhage, CAA-related transient focal neurological episodes(CAA-TFNEs), CAA-related Inflammation(CAA-ri),ischemic stroke during follow-up. |
| From baseline to 6 months and 1 year treatment. |
| Changes of the cerebral blood flow in MRI ASL. | Changes of the CBF are assessed by Arterial Spin Labeling (ASL) MRI techniques at 6months and 12months. | From baseline to 6 months and 1 year treatment. |
| Changes of cognition evaluation on MoCA. | We used MoCA to evaluate the cognitive functions,of subjects at 6months and 12months, such as memory, execution, visuospatial function and so on. | From baseline to 6 months and 1 year treatment. |
| Changes of cognition evaluation on TMT tests. | We used TMT tests to evaluate execution and and so on at 6months and 12months. | From baseline to 6 months and 1 year treatment. |
| Changes of cognition evaluation on stroop tests. | We used stroop tests to evaluate execution and and so on at 6months and 12months. | From baseline to 6 months and 1 year treatment. |
| Changes in evaluation of Timed-Up-and-Go tests. | We used Timed-Up-and-Go tests to evaluate the gait function of subjects at 6months and 12months. | From baseline to 6 months and 1 year treatment. |
| Changes of the whole volume of microbleeds. | The volume of microbleeds was measured on QSM at 6months and 12months. | From baseline to 6 months and 1 year treatment. |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000686 | Amyloidosis |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |