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The purpose of this study is to determine whether remote ischemic postconditioning (RIPostC) initiates autonomic nervous system response and affects the prognosis in patients with acute ischemic stroke.
Remote ischemic postconditioning (RIPostC) has proven effective in reducing the ischemia-reperfusion injury. But the defensive mechanism of RIPostC still unclear. Stroke is frequently associated with autonomic dysfunction. Heart rate variability (HRV) represents the autonomic nervous system activity.This study aims to investigate whether RIPostC correlates with autonomic function and thus predicts prognosis of stroke.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RIPostC | Experimental | Receiving RIPostC with pressure set at 200 mmHg. Intervention:Procedure:Remote Ischemic Postconditioning |
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| sham RIPostC | Sham Comparator | Receiving sham RIPostC with pressure set at the patient's diastolic blood pressure. Intervention:Procedure:Sham Remote Ischemic Postconditioning |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| remote ischemic postconditioning | Procedure | Remote ischemic postconditioning was performed by 4 cycles of upper-limb ischemia and reperfusion.The upper-limb ischemia was induced by inflating a blood pressure cuff on a healthy upper arm to 200 mmHg for 5 min,and then deflating it for 5 min.Each patients in the PIPostC group will have the treatment once a day for 30 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Heart Rate Variabilities | Heart rate variability (HRV) is one of the most promising markers represent for autonomic function.We assess the changes from baseline heart rate variability to 7days and 30days. | at the time points of baseline and 7 and 30 days after treatments |
| Measure | Description | Time Frame |
|---|---|---|
| National Institutes of Health Stroke Scale(NIHSS) | National Institutes of Health Stroke Scale(NIHSS)is a commonly used scale for quantifing the impairment caused by a stroke objectively. | at the time points of baseline and 7days after treatments. |
| Modified Rankin scale(mRS) |
| Measure | Description | Time Frame |
|---|---|---|
| Stroke Recurrence | Stroke recurrence is commonly used to estimate the prognosis of stroke. | 90 days after treatments |
| Mortality | Mortality is commonly used to estimate the prognosis of stroke. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lin WEI, MD | Contact | (08620)81887233 | 30812 | weilin22@126.com |
| Miaomiao MO, Bachelor | Contact | (08620)81887233 | 34528 | momiaomiao11@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Lin WEI, MD | Guangdong Provincial Hospital of Traditional Chinese Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial Hospital of Chinese Medicine | Recruiting | Guangzhou | Guangdong | 510120 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37329785 | Derived | Liang H, Ye R, Zhang X, Ye H, Ouyang W, Cai S, Wei L. Autonomic function may mediate the neuroprotection of remote ischemic postconditioning in stroke: A randomized controlled trial. J Stroke Cerebrovasc Dis. 2023 Aug;32(8):107198. doi: 10.1016/j.jstrokecerebrovasdis.2023.107198. Epub 2023 Jun 15. |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| sham remote ischemic postconditioning | Procedure | Sham remote ischemic postconditioning was performed by 4 cycles of upper-limb ischemia and reperfusion. The upper-limb ischemia was induced by inflating a blood pressure cuff on a healthy upper arm to the patient's actual diastolic blood pressure for 5 min,and then deflating it for 5 min.Each patients in the sham PIPostC group will have the sham treatment once a day for 30 days. |
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The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.The scale runs from 0-6, running from perfect health without symptoms to death.0 - No symptoms.1 - No significant disability. Able to carry out all usual activities, despite some symptoms.2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.3 - Moderate disability. Requires some help, but able to walk unassisted.4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.6 - Dead. |
| at the time points of baseline and 7,30 and 90 days after treatments |
| Barthel Index(BI) | The Barthel Index scale is an ordinal scale used to measure performance in activities of daily living (ADL). Each performance item is rated on this scale with a given number of points assigned to each level or ranking.It uses ten variables describing ADL and mobility. A higher number is associated with a greater likelihood of being able to live at home with a degree of independence following discharge from hospital.The ten variables addressed in the Barthel scale are:presence or absence of fecal incontinence;presence or absence of urinary incontinence;help needed with grooming;help needed with toilet use help needed with feeding;help needed with transfers (e.g. from chair to bed) help needed with walking;help needed with dressing;help needed with climbing stairs;and help needed with bathing. | at the time points of baseline and 7,30 and 90 days after treatments |
| 90 days after treatments |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |