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The primary objective of the study will be to determine whether remote limb ischemic conditioning (RLIC) together with conventional medication therapy compared with only medication therapy reduces the 3-month risk of composite cardio-cerebral vascular event in patients with a recent TIA or IS caused by occlusion of a cerebral artery.
After screening period, eligible patients will be randomly allocated into 2 groups.In addition, all participants receive an usual clinical therapy.
In this study, Patients in the RLIC group will be treated with Renqiao Remote Ischemic Conditioning Device (Doctormate®) (200mmHg) twice daily and conventional medication; patients in the control group will be treated only with conventional medication. In the study, the RLIC treatment will be comprised of 5 cycles of bilateral upper limb ischemia and reperfusion, which will be induced by 2 cuffs placed around the upper arms respectively and inflated to 200mmHg for 5 minutes followed by 5 minutes of reperfusion by cuff deflation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experiment | Experimental |
| |
| Control | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doctormate®+Medical Management | Combination Product | Patients will be treated with Renqiao Remote Ischemic Conditioning Device (Doctormate®) (200mmHg) twice daily and conventional medication for 3 months. |
| Measure | Description | Time Frame |
|---|---|---|
| 3-month composite cardio-cerebral vascular event rate | During the first 3 months from randomization. |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence of TIA or infarction rate in the area of responsible vessel domination within 3 months | During the first 3 months from randomization. | |
| Changes in National Institutes of Health Stroke Scale(NIHSS) within 3 months | During the first 3 months from randomization. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xunming Ji, MD.PhD | Contact | +86-10-83198952 | jixunming@vip.163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xunming Ji, MD.PhD | Xuanwu Hospital, Beijing | Principal Investigator |
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| ID | Term |
|---|---|
| D002537 | Intracranial Arteriosclerosis |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D011216 | Practice Management, Medical |
| ID | Term |
|---|---|
| D020399 | Practice Management |
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
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| Medical Management | Drug | Patients will be treated with conventional medication for 3 months. |
|
| Changes in modified Rankin Scale(mRS) within 3 months | During the first 3 months from randomization. |
| Changes in Barthel Index(BI) within 3 months | During the first 3 months from randomization. |
| 12-month composite cardio-cerebral vascular event rate | During the first 12 months from randomization. |
| D009422 | Nervous System Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020521 | Stroke |