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Effects of Limb Ischemic Postconditioning in Young sICAS (EPIC-sICAS)

Primary Purpose

Stroke

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Remote ischemic postconditioning
Sponsored by
Health Science Center of Xi'an Jiaotong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, Remote ischemic postconditioning, symptomatic atherosclerotic intracranial arterial stenosis

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The First Affiliated Hospital of Xi'an Jiaotong UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Remote Ischemic Postconditioning

Control

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

Mean Change of Collateral Circulation from 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 Outcome Measures

Mean Change of Symptomatic Recovery
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.
A higher amount represents a better outcome

Full Information

First Posted
December 17, 2014
Last Updated
February 1, 2017
Sponsor
Health Science Center of Xi'an Jiaotong University
Collaborators
Xuanwu Hospital, Beijing
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1. Study Identification

Unique Protocol Identification Number
NCT02323425
Brief Title
Effects of Limb Ischemic Postconditioning in Young sICAS
Acronym
EPIC-sICAS
Official Title
Effects of Upper Limb Ischemic Postconditioning on Collateral Circulation in Young Symptomatic Intracranial Atherosclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (Actual)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
March 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Health Science Center of Xi'an Jiaotong University
Collaborators
Xuanwu Hospital, Beijing

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, Remote ischemic postconditioning, symptomatic atherosclerotic intracranial arterial stenosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Remote Ischemic Postconditioning
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Remote ischemic postconditioning
Other Intervention Name(s)
limb ischemic postconditioning
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean Change of Collateral Circulation from Baseline and at 6 months
Description
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.
Time Frame
Baseline and at 6 months
Secondary Outcome Measure Information:
Title
Mean Change of Symptomatic Recovery
Description
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.
Time Frame
Baseline and at 14 days, 1 month, 6 months, and 1 year
Title
Mean Change of serum vascular endothelial growth factor (VEGF) and basic Fibroblast Growth Factor (bFGF) from Baseline and at 10 days.
Description
A higher amount represents a better outcome
Time Frame
Baseline and at 10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Meng Wei, Master
Phone
+8613572516964
Email
67183723@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
GuoGang Luo, M.D/Ph.D
Phone
+8618991232449
Email
lguogang@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GuoGang Luo, M.D/Ph.D
Organizational Affiliation
First Affiliated Hospital Xi'an Jiaotong University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xunming Ji, M.D/Ph.D
Organizational Affiliation
Capital Medical University
Official's Role
Study Director
Facility Information:
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meng Wei, graduate
Phone
+8613572516964
Email
67183723@qq.com
First Name & Middle Initial & Last Name & Degree
GuoGang Luo, M.D/Ph.D
Phone
+8618991232449
Email
lguogang@163.com
First Name & Middle Initial & Last Name & Degree
GuoGang Luo, M.D/Ph.D
First Name & Middle Initial & Last Name & Degree
XunMing Ji, M.D/Ph.D

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Effects of Limb Ischemic Postconditioning in Young sICAS

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