Effects of Limb Ischemic Postconditioning in Young sICAS "EPIC-sICAS"

Recruiting

Phase 2 Results N/A

Update History

28 Jul '15
Trial acronym was updated.
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EPIC-sICAS
Trial name was updated.
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Effects of Limb Ischemic Postconditioning in Young sICAS
The Summary of Purpose was updated.
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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.
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The purpose of this study is to evaluate the protective effects of upper limb ischemic postconditioning on collateral circulation after cerebral Infarction, as an open, randomized controlled, prospective controlled trial.
The description was updated.
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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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Stroke is one of the leading causes of human death and adult disability. Collateral flow is an important determinant of brain tissue protection during an ischemic event. studies using animal models has confirmed that remote ischemic postconditioning (RIPC) can reduce infarct size of cerebral infarction. Investigators hypothesized that postconditioning would reduce infarct volume of ischemic stroke patients, in ways of promoting collateral circulation. Besides,a few drugs were proved to be beneficial to collateral circulation.
The minimum age criteria for eligibility was updated to "18 Years."
The eligibility criteria were updated.
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Inclusion Criteria: 1. Age between 18 to 45 Years old; 2. Symptomatic intracranial atherosclerotic stenosis (sICAS): cranial CTA/MRA/TCD/DSA confirm the diagnosis, patients got ischemic stroke or transient ischemic attack in the brain region supplied by the stenosis artery; 3. National Institutes of Health Stroke Scale(NIHSS) score 0-15 4. Written informed consent was signed. Exclusion Criteria: 1. Cerebral hemorrhage and other parts of the active bleeding disease; 2. Severe aphasia, unable to express himself; 3. A history of brain tumor, brain trauma, cerebral embolism or other brain lesions; 4. Severe lesions of severe cardiac, liver or kidney disease, malignancy or other systemic organ dysfunction; 5. Blood Pressure< 90 mmHg/60 mmHg or >200 mmHg/110 mmHg after treatment; 6. Dementia and mental illness; 7. Using angiotensin-converting enzyme inhibitors; 8. A history of major surgery or trauma 4 weeks prior to admission; 9. Without informed consent. Elimination Criteria: 1. Patients with poor compliance,refuse to take regular treatment and examination; 2. patients' condition get exacerbated, with NIHSS score elevate for more than 4.
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Inclusion Criteria: 1. Age between 50 to 75 Years old 2. First-episode cerebral infarction (NIHSS scores<24,and>4); onset within 72 hours. The atherosclerotic stenosis rate of internal carotid artery is more than 50% to totally occluded,confirmed by ultrasound. 3. Cranial CT/MRI confirm the diagnosis 4. Capable of detecting temple window by TCD 5. written informed consent was signed Exclusion Criteria: 1. Cerebral hemorrhage and other parts of the active bleeding disease 2. Severe aphasia,unable to express himself. 3. A history of cerebral hemorrhage, brain tumor, brain trauma, cerebral embolism or other brain lesions 4. Severe lesions of severe cardiac, liver or kidney disease, malignancy or other systemic organ dysfunction 5. Blood Pressure< 90 mmHg/60 mmHg or >200 mmHg/110 mmHg after treatment 6. Dementia and mental illness 7. Using angiotensin-converting enzyme inhibitors 8. A history of major surgery or trauma 4 weeks prior to admission. 9. Without informed consent Elimination Criteria: 1. Patients with poor compliance,refuse to take regular treatment and examination 2. patients' condition get exacerbated, with NIHSS score elevate for more than 4.
28 May '15
Trial acronym was updated.
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EULIPCCS
Trial name was updated.
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Effects of Upper Limb Ischemic Postconditioning on Collateral Circulation After Stroke
The Summary of Purpose was updated.
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The purpose of this study is to evaluate the protective effects of upper limb ischemic postconditioning on collateral circulation after cerebral Infarction, as an open, randomized controlled, prospective controlled trial.
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The purpose of this study is to evaluate the protective effects of upper limb ischemic postconditioning in combination with drugs (urinary kallidinogenase) on collateral circulation after cerebral Infarction, as an open, nonrandomized controlled, prospective controlled trial.
The minimum age criteria for eligibility was updated to "50 Years."
The eligibility criteria were updated.
New
Inclusion Criteria: 1. Age between 50 to 75 Years old 2. First-episode cerebral infarction (NIHSS scores<24,and>4); onset within 72 hours. The atherosclerotic stenosis rate of internal carotid artery is more than 50% to totally occluded,confirmed by ultrasound. 3. Cranial CT/MRI confirm the diagnosis 4. Capable of detecting temple window by TCD 5. written informed consent was signed Exclusion Criteria: 1. Cerebral hemorrhage and other parts of the active bleeding disease 2. Severe aphasia,unable to express himself. 3. A history of cerebral hemorrhage, brain tumor, brain trauma, cerebral embolism or other brain lesions 4. Severe lesions of severe cardiac, liver or kidney disease, malignancy or other systemic organ dysfunction 5. Blood Pressure< 90 mmHg/60 mmHg or >200 mmHg/110 mmHg after treatment 6. Dementia and mental illness 7. Using angiotensin-converting enzyme inhibitors 8. A history of major surgery or trauma 4 weeks prior to admission. 9. Without informed consent Elimination Criteria: 1. Patients with poor compliance,refuse to take regular treatment and examination 2. patients' condition get exacerbated, with NIHSS score elevate for more than 4.
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Inclusion Criteria: 1. Age between 18 to 75 Years old 2. First-episode cerebral infarction (NIHSS scores<24,and>4); onset within 72 hours. The atherosclerotic stenosis rate of internal carotid artery is more than 50% to totally occluded. 3. Cranial CT/MRI confirm the diagnosis 4. Capable of detecting temple window by TCD 5. written informed consent was signed Exclusion Criteria: 1. Cerebral hemorrhage and other parts of the active bleeding disease 2. Unconsciousness or NIHSS scores>25 3. A history of cerebral hemorrhage, brain tumor, brain trauma, cerebral embolism or other brain lesions 4. Severe lesions of severe cardiac, liver or kidney disease, malignancy or other systemic organ dysfunction 5. Blood Pressure< 90 mmHg/60 mmHg or >200 mmHg/110 mmHg after treatment 6. Dementia and mental illness 7. Using angiotensin-converting enzyme inhibitors 8. A history of major surgery or trauma 4 weeks prior to admission. 9. Allergic constitution: the history of allergy to multi-drug 10. Without informed consent
A location was updated in Xi'an.
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The overall status was updated to "Recruiting" at The First Affiliated Hospital of Xi'an Jiaotong University.