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This is a single-arm, open-labeled and phase II futility study. Application of Remote ischemic conditioning (RIC) as an adjunctive therapy to medication were involved in the study. The study is to test whether RIC is effective in preventing ischemic evens after a minor ischemic stroke/transient ischemic attack within 3 months and to explore the safety and compliance of chronic RIC. Medication strategy is based on physician's best judgement.
This is a single-arm, open-labeled and phase II futility study. Application of Remote ischemic conditioning (RIC) as an adjunctive therapy to medication were involved in the study. RIC consisted of five cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuff on bilateral upper limbs twice a day. The study is to test whether RIC is effective in preventing ischemic evens after a minor ischemic stroke/transient ischemic attack within 3 months and to explore the safety and compliance of chronic RIC. Medication strategy is based on physician's best judgement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remote Ischemic Conditioning | Experimental | RIC (remote ischemic conditioning) consists of five cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuff on bilateral upper limbs twice a day. Medication strategy is based on physician's best judgement. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote Ischemic Conditioning | Device | RIC consist of five cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuff on bilateral upper limbs twice a day. Medication strategy is based on physician's best judgement. |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrent rate of ischemic stroke/transient ischemic stroke | within 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-Related Adverse Events | pain and tolerability, redness, bleeding, palpitation | within 3 months |
| Compliance of remote ischemic conditioning | the proportion of patients fulfill the treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrent rate of ischemic stroke/transient ischemic stroke within 1 months | within 1 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xunming Ji, MD, PhD | Xuanwu Hospital, Beijing | Principal Investigator |
| Wuwei Feng, MD, MS | Medical University of South Carolina | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital, Capital Medical University | Beijing | Beijing Municipality | 100053 | China | ||
| First Affiliated Hospital of Hainan Medical University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29363651 | Derived | Liu SM, Zhao WL, Song HQ, Meng R, Li SJ, Ren CH, Ovbiagele B, Ji XM, Feng WW. Rationale and Study Design for a Single-Arm Phase IIa Study Investigating Feasibility of Preventing Ischemic Cerebrovascular Events in High-Risk Patients with Acute Non-disabling Ischemic Cerebrovascular Events Using Remote Ischemic Conditioning. Chin Med J (Engl). 2018 Feb 5;131(3):347-351. doi: 10.4103/0366-6999.223849. |
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| ID | Term |
|---|---|
| D002546 | Ischemic Attack, Transient |
| ID | Term |
|---|---|
| D002545 | Brain Ischemia |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Patients will receive remote ischemic conditioning
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| within 3 months |
| Incidence rate of vascular events | hemorrhage stroke, myocardial infarction and vascular death | within 3 months |
| Improvements in NIH Stroke Scale | improvements in NIH Stroke Scale in patients without recurrence or vascular events | within1, 3 months |
| Improvements in modified Rankin Scale | improvements in modified Rankin Scale Scale in patients without recurrence or vascular events | within 1, 3 months |
| Improvements in Barthel Scale | improvements in Barthel Scale in patients without recurrence or vascular events | within 1,3 months |
| Haikou |
| Hainan |
| 570102 |
| China |
| Taoyuan People's Hospital | Changde | Hunan | China |
| Shengli Oilfield Center Hospital | Dongying | Shandong | 257034 | China |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |