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The purpose of this study is to determine the safety and feasibility of remote limb ischemic conditioning(RIC) in acute ischemic stroke patients who received r-tPA thrombolytic therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RIC group | Experimental | The upper limb ischemic conditioning is composed of five cycles of upper limb ischemia intervened by reperfusion, which is induced by two cuff placed around the upper arms respectively and inflated to 200 mm Hg for 5 minutes followed by 5 minutes of reperfusion by cuff deflation. This therapy started within 2 hours after r-tPA thrombolytic therapy. In addition, all participants receive a standard clinical therapy. |
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| Control group | No Intervention | The participants received r-tPA thrombolytic therapy after diagnosed ischemic stroke. In addition, all participants receive a standard clinical therapy. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote ischemic conditioning | Device | In this study, the remote ischemic conditioning treatment was composed of five cycles of bilateral upper limb ischemia intervened by reperfusion, which was induced by two cuff placed around the upper arms respectively and inflated to 200 mm Hg for 5 minutes followed by 5 minutes of reperfusion by cuff deflation. Doctormate, IPC-906 |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of RIC after acute ischemic stroke | The proportion of enrolled subjects that completed all the designed RIC procedures. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Objective signs of tissue or neurovascular injury | objective signs of tissue or neurovascular injury felt to be due to cuff inflation. Inspection included palpation of distal radial pulses, visual inspection (for local edema, redness, skin breakdown), and palpation for tenderness | within 7(±24h) days |
| Number of participants with intracranial hemorrhage in two groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital, Capital Medical University | Beijing | XI Cheng District | 100053 | China |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| 7(±24h)days |
| Scores assessed by National Institutes of Health Stroke Scale(NIHSS) | 7(±24h)days |
| The functional outcome at 90 days assessed by modified Rankin scale (mRS). | 90( ±7days) days |
| functional outcome assessed by Barthel Index(BI) | 90( ±7days)days |
| cerebral infarct volume. | The infarct volume of cerebral infarct is evaluated by cranial noncontrast MRI | 3-7 days after stroke onset |
| cerebral infarct volume. | The infarct volume of cerebral infarct is evaluated by cranial noncontrast CT | 3-7 days after stroke onset |
| Cardiovascular parameters during 7 days of RIC treatment. | the blood pressure were measured immediately before RIC and also be measured 5 minutes after RIC. | 7 days |
| the heart rate during 7 days of RIC treatment. | the heart rate were measured immediately before RIC and also be measured 5 minutes after RIC. | 7 days |
| Levels of plasma myoglobin | baseline and 7(±2)days |
| Levels of serum IL-6 | baseline and 7(±2)days |
| Levels of serum HS-CRP | baseline and 7(±2)days |
| Levels of serum HCY | baseline and 7(±2)days |
| Any adverse events | 90(±7)days |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |