Effects of Limb Ischemic Postconditioning in Young sICAS

Overview

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.

Full Title of Study: “Effects of Upper Limb Ischemic Postconditioning on Collateral Circulation in Young Symptomatic Intracranial Atherosclerosis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2018

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.

Interventions

  • Device: 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 automatically.

Arms, Groups and Cohorts

  • 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.
  • 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).

Clinical Trial Outcome Measures

Primary Measures

  • Mean Change of Collateral Circulation from Baseline and at 6 months
    • Time Frame: 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.

Secondary Measures

  • Mean Change of Symptomatic Recovery
    • Time Frame: Baseline and at 14 days, 1 month, 6 months, and 1 year
    • 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.
  • 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
    • A higher amount represents a better outcome

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Health Science Center of Xi’an Jiaotong University
  • Collaborator
    • Xuanwu Hospital, Beijing
  • Provider of Information About this Clinical Study
    • Principal Investigator: Meng Wei, Director, Clinical Research – Health Science Center of Xi’an Jiaotong University
  • Overall Official(s)
    • GuoGang Luo, M.D/Ph.D, Principal Investigator, First Affiliated Hospital Xi’an Jiaotong University
    • Xunming Ji, M.D/Ph.D, Study Director, Capital Medical University
  • Overall Contact(s)
    • Meng Wei, Master, +8613572516964, 67183723@qq.com

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