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| Name | Class |
|---|---|
| Xuanwu Hospital, Beijing | OTHER |
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The purpose of this study is to evaluate the protective effects of upper limb ischemic postconditioning on collateral circulationin young symptomatic intracranial atherosclerosis and the baseline characteristics of trial participants, as an open, randomized controlled, prospective controlled trial.
Stroke is a common cardia-cerebrovascular disease with high morbidity, disability and mortality rate. And more and more young patients account for the increasing morbidity. Among them, Symptomatic intracranial atherosclerotic stenosis(sICAS)is a major cause, especially in Asians.
Currently, traditional therapeutic methods present reluctant achievements on reducing stroke recurrence and pose threat on patients'health because of invasive operation and severe side effects. Therefore, other treatment methods are called for urgently. Remote ischemic post-conditioning refers to local or distal ischemia treatment after the occurrence of cerebral ischemia. Prior research has shown that repeatedly ischemic reperfusion have protective effect on lowering the occurrence rate of ischemic events of patients with carotid stenosis. However, in-depth research on cerebral protection and correlation with collateral circulation has not been proven in an open, definitive clinical trial.
Thus, the EPIC-sICAS trial will provide important information on the protective effects of upper limb ischemic post-conditioning on collateral circulation after cerebral Infarction. Hopefully to present us a very meaningful way to improve the patient's quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remote Ischemic Postconditioning | Experimental | remote ischemic postconditioning(RIPC) treatment was performed by the inflating a cuff around bilateral arms to 180 mmHg with 5 cycles of 3 min inflation and 5 min relax alternation twice a day for the total of 180 consecutive days. |
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| Control | No Intervention | Patients in control group will receive foundation treatment. Foundation treatment: including blood vessel expansion、free radical elimination etc during acute phase and aspirin (100-300 mg/d), and atorvastatin (20 mg/d) till the end of the study (180 consecutive days). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote ischemic postconditioning | Device | Remote ischemic postconditioning(RIPC)treatment was performed by the inflating a cuff around bilateral arms to 180 mmHg with 5 cycles of 3 min inflation and 5 min relax alternation automatically. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change of Collateral Circulation from Baseline and at 6 months | Collateral circulation measured in iconography test: Magnetic Resonance Angiography (MRA)、 Dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI)、Arterial spin-labeled (ASL) perfusion magnetic resonance、Transcranial Cerebral Doppler (TCD)、single photon emission computed tomography(SPECT) Baseline was defined as the onset of stroke within 48h. A higher score represents better collateral circulation status functioning. | Baseline and at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change of Symptomatic Recovery | Functional test: National Institute of Health stroke scale(NIHSS)scores、Activity of Daily Living Scale (ADL) For NIHSS scores, a lower score represents better functioning. For ADL scores, a higher score represents better functioning. | Baseline and at 14 days, 1 month, 6 months, and 1 year |
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Inclusion Criteria:
Exclusion Criteria:
Elimination Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meng Wei, Master | Contact | +8613572516964 | 67183723@qq.com | |
| GuoGang Luo, M.D/Ph.D | Contact | +8618991232449 | lguogang@163.com |
| Name | Affiliation | Role |
|---|---|---|
| GuoGang Luo, M.D/Ph.D | First Affiliated Hospital Xi'an Jiaotong University | Principal Investigator |
| Xunming Ji, M.D/Ph.D | Capital Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Xi'an Jiaotong University | Recruiting | Xi'an | Shaanxi | 710061 | China |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 4, 2018 | |
| Reset | Jan 10, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 4, 2018 | Jan 10, 2019 |
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| Mean Change of serum vascular endothelial growth factor (VEGF) and basic Fibroblast Growth Factor (bFGF) from Baseline and at 10 days. |
A higher amount represents a better outcome |
| Baseline and at 10 days |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |