Effects of Limb Ischemic Postconditioning in Young sICAS (EPIC-sICAS)
Effects of Upper Limb Ischemic Postconditioning on Collateral Circulation in Young Symptomatic Intracranial Atherosclerosis
Study Overview
Detailed Description
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Shaanxi
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Xi'an, Shaanxi, China, 710061
- Recruiting
- The First Affiliated Hospital of Xi'an Jiaotong University
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Contact:
- GuoGang Luo, M.D/Ph.D
- Phone Number: +8618991232449
- Email: lguogang@163.com
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Contact:
- Meng Wei, graduate
- Phone Number: +8613572516964
- Email: 67183723@qq.com
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Principal Investigator:
- GuoGang Luo, M.D/Ph.D
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Principal Investigator:
- XunMing Ji, M.D/Ph.D
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age between 18 to 45 Years old;
- 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;
- National Institutes of Health Stroke Scale(NIHSS) score 0-15
- Written informed consent was signed.
Exclusion Criteria:
- Cerebral hemorrhage and other parts of the active bleeding disease;
- Severe aphasia, unable to express himself;
- A history of brain tumor, brain trauma, cerebral embolism or other brain lesions;
- Severe lesions of severe cardiac, liver or kidney disease, malignancy or other systemic organ dysfunction;
- Blood Pressure< 90 mmHg/60 mmHg or >200 mmHg/110 mmHg after treatment;
- Dementia and mental illness;
- Using angiotensin-converting enzyme inhibitors;
- A history of major surgery or trauma 4 weeks prior to admission;
- Without informed consent.
Elimination Criteria：
- Patients with poor compliance，refuse to take regular treatment and examination;
- patients' condition get exacerbated, with NIHSS score elevate for more than 4.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Remote Ischemic Postconditioning
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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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.
Other Names:
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No Intervention: Control
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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Mean Change of Collateral Circulation from Baseline and at 6 months
Time Frame: Baseline and at 6 months
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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.
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Baseline and at 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Mean Change of Symptomatic Recovery
Time Frame: Baseline and at 14 days, 1 month, 6 months, and 1 year
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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.
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Baseline and at 14 days, 1 month, 6 months, and 1 year
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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.
Time Frame: Baseline and at 10 days
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A higher amount represents a better outcome
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Baseline and at 10 days
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: GuoGang Luo, M.D/Ph.D, First Affiliated Hospital Xi'an Jiaotong University
- Study Director: Xunming Ji, M.D/Ph.D, Capital Medical University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- XIANJ-14ZD25
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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