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| Name | Class |
|---|---|
| Wangjing Hospital, China Academy of Chinese Medical Sciences | OTHER |
| Bejing Fengtai You'anmen Hospital | UNKNOWN |
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Cerebral amyloid angiopathy-related intracerebral (CAAH) hemorrhage is second factor of primary intracerebral hemorrhage. However, no effective prevention and treatment strategies have been established. Remote ischemic conditioning is a neuroprotective strategy. In animal studies,RIC is efficiency in accelerating the absorption of hematoma. Therefore, the investigators plan to carry out this research to evaluate the safety and efficacy of RIC in patients with CAA related ICH.
In China, primary intracerebral hemorrhage accounts for 80-85% of all types of intracerebral hemorrhage, while cerebral amyloid angiopathy-related intracerebral hemorrhage is the second factor, accounting for approximately 20-30%. It is often characterized by repeated and multifocal lobar hemorrhage, which will not only cause neurological deficit on the limbs, but also influence the cognitive level of patients and may even be life-threatening. At present, the role of surgery in CAA-related ICH is controversial, and there is no effective prevention and treatment strategies have been established. Additionally, it is always associated with a low rate of good prognosis(11%-60%) and a high risk of recurrent ICH (10%-60%). Thus, a novel approach which can improve the clinical outcome and reduce the risk of recurrent intracerebral hemorrhage is urgently needed.
Remote ischemic conditioning (RIC) has been developed as a neuroprotective strategy to prevent and treat acute ischemic stroke and small cerebrovascular disease. Additionally, clinical research testified that RIC is safe and feasible for patients with subarachnoid hemorrhage. In animal studies, RIC is efficiency in accelerating the absorption of hematoma. Therefore, the investigators plan to carry out this research to evaluate the safety and efficacy of RIC in patients with CAA related ICH.
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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 autocontrol 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 once daily for consecutive 10-14 days after enrollment. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events | Safety | 90±7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of intracerebral hematoma volume | Intracerebral hematoma volume (ml) is assessed by CT brain scan. | 14± 2 days |
| Changes of perihematomal edema volume | Perihematomal edema volume (ml) is assessed by CT brain scan. |
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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 | |
| Ruiwen Che, MD | Contact | rwcadl@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xunming Ji | 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 |
|---|---|---|---|
| 25692104 | Background | Yamada M. Cerebral amyloid angiopathy: emerging concepts. J Stroke. 2015 Jan;17(1):17-30. doi: 10.5853/jos.2015.17.1.17. Epub 2015 Jan 30. | |
| 20044530 | Background | Arima H, Tzourio C, Anderson C, Woodward M, Bousser MG, MacMahon S, Neal B, Chalmers J; PROGRESS Collaborative Group. Effects of perindopril-based lowering of blood pressure on intracerebral hemorrhage related to amyloid angiopathy: the PROGRESS trial. Stroke. 2010 Feb;41(2):394-6. doi: 10.1161/STROKEAHA.109.563932. Epub 2009 Dec 31. |
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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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| 14± 2 days |
| Incidence rate of the perihematomal edema expansion | The enlargement of perihematomal edema volume (ml) is assessed by CT brain scan. | 14± 2 days |
| Shift of midline brain structure | Shift of midline brain structure (mm) is assessed by CT brain scan | 14± 2 days |
| Prognosis of function outcome at 90 Days | accessed by modified Rankin score | 90±7 days |
| Prognosis of neurological function at 90 Days | The Barthel index will be assessed at follow-up. | 90±7 days |
| Changes of serum biomarker of blood brain barrier (Matrix metalloproteinases,MMPs) | The biomarker of blood brain barrier(MMPs) are assemented by the same laboratory. | 7± 2 days |
| Changes of serum biomarker of inflammatory ( interleukin) | The interleukin will be assemented by the same laboratory. | 7± 2 days |
| Other adverse events related to RIC treatment | Other adverse events related to RIC treatment,such as mucocutaneous hemorrhage,changes in coagulation function and so on. | 90±7 days |
| 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 |