| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Acute Ischemic Stroke | Device: remote ischemic conditioning Device: sham remote ischemic conditioning | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 50 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Safety and Effectiveness of Remote Ischemic Conditioning Combined With Intravenous Thrombolysis in Treating Acute Ischemic Stroke |
| Actual Study Start Date : | July 1, 2019 |
| Actual Primary Completion Date : | October 1, 2019 |
| Actual Study Completion Date : | January 1, 2020 |
| Arm | Intervention/treatment |
|---|---|
|
Active Comparator: RIC group
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 re-perfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 200 mm Hg. RIC will be conducted twice within 6 to 24 hours from thrombolysis. Additionally,the patients will be treated with standard medical treatment according to Guidelines for diagnosis and treatment of acute ischemic stroke in China 2014.
|
Device: remote ischemic conditioning
Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min re-perfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 200 mm Hg.
|
|
Placebo Comparator: control group
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 re-perfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mm Hg. RIC will be conducted twice twice within 6 to 24 hours from thrombolysis. Additionally,the patients will be treated with standard medical treatment according to Guidelines for diagnosis and treatment of acute ischemic stroke in China 2014
|
Device: sham remote ischemic conditioning
Sham remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min re-perfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mm Hg.
|
| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
| China, Jilin | |
| The First Hospital of Jilin University | |
| Chang chun, Jilin, China, 130000 | |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | July 14, 2019 | ||||
| First Posted Date ICMJE | July 22, 2019 | ||||
| Last Update Posted Date | January 13, 2020 | ||||
| Actual Study Start Date ICMJE | July 1, 2019 | ||||
| Actual Primary Completion Date | October 1, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures |
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| Original Other Pre-specified Outcome Measures | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Safety and Effectiveness of Remote Ischemic Conditioning Combined With Intravenous Thrombolysis in Treating Acute Ischemic Stroke | ||||
| Official Title ICMJE | Safety and Effectiveness of Remote Ischemic Conditioning Combined With Intravenous Thrombolysis in Treating Acute Ischemic Stroke | ||||
| Brief Summary | 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. | ||||
| Detailed Description | In this study, 50 cases of ischemic stroke who undergo intravenous thrombolysis within 4.5 hours from onset are included. The experimental group receive basic treatment and remote ischemic conditioning for 200mmHg, 2 times within 6 hours to 24 hours from thrombolysis. The control group receive basic treatment and remote ischemic conditioning control for 60mmHg, 2 times within 6 hours to 24 hours from thrombolysis . 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. | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Acute Ischemic Stroke | ||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE |
50 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Actual Study Completion Date ICMJE | January 1, 2020 | ||||
| Actual Primary Completion Date | October 1, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 80 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | China | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT04027621 | ||||
| Other Study ID Numbers ICMJE | SERICT-AIS | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | Yi Yang, The First Hospital of Jilin University | ||||
| Study Sponsor ICMJE | Yi Yang | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| PRS Account | The First Hospital of Jilin University | ||||
| Verification Date | January 2020 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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