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| Name | Class |
|---|---|
| National Natural Science Foundation of China | OTHER_GOV |
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This study is a prospective, randomized, single-center trial, designed to observe the effect of remote limb ischemic preconditioning on ischemic cerebral vascular disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RIPC+stroke secondary prevension | Experimental | Procedure/Surgery: Remote Ischemic Preconditioning (RIPC) The detail of RIPC included five cycles of bilateral upper limbs 5/5 min. of ischemia and reperfusion alternation. Limb ischemia was induced by inflating tourniquets to 200 mmHg. This process was placed on both arms every day. Procedure:stroke secondary prevention(Such as Antiplatelet therapy, Cholesterol-lowering therapymaintain blood pressure and blood sugar normal) |
|
| stroke secondary prevention | No Intervention | Procedure:stroke secondary prevention(Such as Antiplatelet therapy, Cholesterol-lowering therapymaintain blood pressure and blood sugar normal) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote ischemic preconditioning (RIPC) | Procedure | The detail of RIPC included five cycles of bilateral upper limbs 5/5 min. of ischemia and reperfusion alternation. Limb ischemia was induced by inflating tourniquets to 200 mmHg. This process was placed on both arms every day. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure and Heart Rates; | at the time points of baseline and 1, 15 and 30 days after BLIPC treatment | |
| Plasma Biomarkers of Coagulation and Fibrinolysis | blood samples were collected one hour after every times of BLIPC procedure ended, and assayed with the immuno-turbidimetry assay on the coagulation laboratory autoanalyzer | the time points of baseline and 1, 15 and 30 days after BLIPC treatment |
| Number of Patients Who Got New Brain Lesions | We compared the number of patients who got new lesions in the Diffusion-weighted magnetic resonance imaging (DWI-MRI) | 300 days after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| The Time Point Until the First Stroke Recurrence, | These patients underwent MRI/DWI at the time of first recurrence; patients without symptoms recurrence underwent follow-up MRI/DWI at 300 days. | At the 300-day after the initial treatment |
| Brain Perfusion Improvement Are Evaluated With SPECT and TCD |
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Inclusion criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital, Capital Medical University | Xicheng District | Beijing P.R. | 100053 | China |
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| ID | Title | Description |
|---|---|---|
| FG000 | RIPC+Stroke Secondary Prevension | Procedure/Surgery: RIPC The detail of RIPC included five cycles of bilateral upper limbs 5/5 min. of ischemia and reperfusion alternation. Limb ischemia was induced by inflating tourniquets to 200 mmHg. This process was placed on both arms every day. Procedure:stroke secondary prevention |
| FG001 | Stroke Secondary Prevention | Procedure:stroke secondary prevention |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | RIPC+Stroke Secondary Prevension | Procedure/Surgery: RIPC The detail of RIPC included five cycles of bilateral upper limbs 5/5 min. of ischemia and reperfusion alternation. Limb ischemia was induced by inflating tourniquets to 200 mmHg. This process was placed on both arms every day. Procedure:stroke secondary prevention |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Blood Pressure and Heart Rates; | Not Posted | at the time points of baseline and 1, 15 and 30 days after BLIPC treatment | |||||||||||||
| Primary | Plasma Biomarkers of Coagulation and Fibrinolysis | blood samples were collected one hour after every times of BLIPC procedure ended, and assayed with the immuno-turbidimetry assay on the coagulation laboratory autoanalyzer | Not Posted | the time points of baseline and 1, 15 and 30 days after BLIPC treatment |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | RIPC+Stroke Secondary Prevension | Procedure/Surgery: RIPC The detail of RIPC included five cycles of bilateral upper limbs 5/5 min. of ischemia and reperfusion alternation. Limb ischemia was induced by inflating tourniquets to 200 mmHg. This process was placed on both arms every day. Procedure:stroke secondary prevention |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| transient sporadic subcutaneous bleeding points | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Xunming Ji, M.D.,Ph.D. | XuanWu Hospital, Capital Medical University | 8683198127 | jixm70@hotmail.com , Jixm@ccmu.edu.cn |
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| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
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Brain perfusion status were evalvated by SPECT SPECT scanning was performed using a dual headed rotating gamma camera at 30 minutes after intravenous 99mTc-ECD (25mCi) bolus injection and at 40 minutes after 18F -FDG bolus injection. |
| 300-day after treatment |
| Withdrawal by Subject |
|
| Stroke Secondary Prevention |
Procedure:stroke secondary prevention |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Primary | Number of Patients Who Got New Brain Lesions | We compared the number of patients who got new lesions in the Diffusion-weighted magnetic resonance imaging (DWI-MRI) | Posted | Number | participants | 300 days after treatment |
|
|
|
|
| Secondary | The Time Point Until the First Stroke Recurrence, | These patients underwent MRI/DWI at the time of first recurrence; patients without symptoms recurrence underwent follow-up MRI/DWI at 300 days. | Not Posted | At the 300-day after the initial treatment |
| Secondary | Brain Perfusion Improvement Are Evaluated With SPECT and TCD | Brain perfusion status were evalvated by SPECT SPECT scanning was performed using a dual headed rotating gamma camera at 30 minutes after intravenous 99mTc-ECD (25mCi) bolus injection and at 40 minutes after 18F -FDG bolus injection. | Not Posted | 300-day after treatment |
| 0 |
| 51 |
| 3 |
| 51 |
| EG001 | Stroke Secondary Prevention | Procedure:stroke secondary prevention | 0 | 52 | 0 | 52 |
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| D002318 | Cardiovascular Diseases |