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
Not provided
The purpose of this study is to determine the efficacy and safety of remote ischemic conditioning combined with intravenous thrombolysis in treating acute ischemic stroke.
In this study, 558 cases of ischemic stroke who undergo intravenous thrombolysis within 4.5 hours from the onset are included in 18 centers in China according to the principle of random, and parallel control. The experimental group receive basic treatment and remote ischemic conditioning for 200mmHg, 2 times per day for 7 consecutive days. The control group receive basic treatment and remote ischemic conditioning control for 60mmHg, 2 times per day for 7 consecutive days. Two groups will be followed up for 90 days to evaluate the efficacy and safety of remote ischemic conditioning combined with intravenous thrombolysis in treating acute ischemic stroke.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RIC+Standard medical treatment | Active Comparator | RIC+Standard medical treatment Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 200 mm Hg. RIC will be conducted twice daily for 7 consecutive days from thrombolysis. Additionally, the patients will be treated with standard medical treatment according to the Guidelines for diagnosis and treatment of acute ischemic stroke in China. |
|
| Sham RIC+Standard medical treatment | Placebo Comparator | Sham RIC+Standard medical treatment Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mm Hg. RIC will be conducted twice daily for 7 consecutive days from thrombolysis. Additionally, the patients will be treated with standard medical treatment according to the Guidelines for diagnosis and treatment of acute ischemic stroke in China. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote ischemic conditioning | Procedure | Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflations of a blood pressure cuff to 200 mm Hg. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with Modified Rankin Scale (mRS) Score 0-1 | Proportion of patients with Modified Rankin Scale (mRS) Score 0-1. Ranged from 0 to 6, a low value represents a better outcome. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| National Institute of Health stroke scale (NIHSS) at 24 hours, and 7 days after IVT. | National Institute of Health stroke scale (NIHSS) at 24 hours, and 7 days after IVT. Ranged from 0 to 42, a low value represents a better outcome. | 24 hours, 7 days |
| Barthel Index (BI) at 24 hours, and 7 days after IVT. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Hospital of Jilin University | Changchun | Jilin | 130000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39772709 | Derived | Guo ZN, Abuduxukuer R, Zhang P, Qu Y, Wang LJ, Zhao JF, Ju DS, Wang JM, Jin HM, Wang WW, Teng RH, Gao JH, Yuan ZM, Gao HF, Jiang YF, Li ZD, He Y, Jiang LG, Li L, Hu XF, Jiang CL, Wang R, Qi YB, Xin H, Jia Y, Yu H, Jin H, Chen HS, Wang DL, Nguyen TN, Yang Y; SERIC-IVT study group. Safety and Efficacy of Remote Ischemic Conditioning in Patients With Intravenous Thrombolysis: The SERIC-IVT Trial. Stroke. 2025 Feb;56(2):335-343. doi: 10.1161/STROKEAHA.124.048509. Epub 2025 Jan 8. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Sham remote ischemic conditioning | Procedure | Sham remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflations of a blood pressure cuff to 60 mm Hg. |
|
Barthel Index (BI) at 24 hours, and 7 days after IVT. Ranged from 0 to 100, a high value represents a better outcome. |
| 24 hours, 7 days |
| Proportion of patients with modified Rankin Scale (mRS) Score 0-2 at 90±3 days after IVT. | Proportion of patients with modified Rankin Scale (mRS) Score 0-2 at 90±3 days after IVT. mRS: Ranged from 0 to 6, a low value represents a better outcome. | 90±3 days |
| Frequency of adverse events during follow-up | All adverse events through 90 days. | 90 days |
| Frequency of Hemorrhagic transformation within 24 hours after IVT. | Frequency of Hemorrhagic transformation within 24 hours after IVT. | 24 hours |
| Mortality within 90 days. | Mortality within 90 days. | 90 days |
| Stroke recurrence rate within 90 days. | Stroke recurrence rate within 90 days. | 90 days |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |