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Impact of Remote Ischemic Postconditioning on Autonomic Function in Stroke Patients (IRAS)

Primary Purpose

Ischemic Stroke

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
remote ischemic postconditioning
sham remote ischemic postconditioning
Sponsored by
Guangzhou University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ischemic Stroke focused on measuring remote ischemic postconditioning, autonomic function, heart rate variability, acute ischemic stroke, prognosis

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Diagnosed as ischemic stroke according to the Chinese guideline of diagnosis and treatment of acute ischemic stroke 2010
  2. Age between 18 to 85 years old
  3. initial ischemic stroke within 14 days or less.
  4. National Institutes of Health Stroke Scale (NIHSS)score 0-15
  5. Modified Rankin Scale(mRS)score 1-4
  6. Informed consent

Exclusion Criteria:

  1. Intravenous or arterial thrombolysis, or revascularization
  2. Acute myocardial infarction,atrial fibrillation,arrhythmia,or cardiogenic cerebral embolism
  3. Systolic Blood Pressure(SBP)>200mmHg after medication treatment
  4. Plasma fibrinogen>7g/L
  5. Upper limb fracture or percutaneous injury
  6. Subclavian artery stenosis
  7. With severe cardiac,respiratory,hepatic,and renal dysfunction or malignant tumor
  8. Simultaneous participation in another interventional study
  9. Pregnancy

Sites / Locations

  • Guangdong Provincial Hospital of Chinese MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

RIPostC

sham RIPostC

Arm Description

Receiving RIPostC with pressure set at 200 mmHg. Intervention:Procedure:Remote Ischemic Postconditioning

Receiving sham RIPostC with pressure set at the patient's diastolic blood pressure. Intervention:Procedure:Sham Remote Ischemic Postconditioning

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Modified Rankin scale(mRS)
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.
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.

Full Information

First Posted
May 17, 2016
Last Updated
September 27, 2017
Sponsor
Guangzhou University of Traditional Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02777099
Brief Title
Impact of Remote Ischemic Postconditioning on Autonomic Function in Stroke Patients
Acronym
IRAS
Official Title
Impact of Remote Ischemic Postconditioning on Autonomic Function and Prognosis in Clients With Acute Ischemic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
February 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guangzhou University of Traditional Chinese Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
Keywords
remote ischemic postconditioning, autonomic function, heart rate variability, acute ischemic stroke, prognosis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RIPostC
Arm Type
Experimental
Arm Description
Receiving RIPostC with pressure set at 200 mmHg. Intervention:Procedure:Remote Ischemic Postconditioning
Arm Title
sham RIPostC
Arm Type
Sham Comparator
Arm Description
Receiving sham RIPostC with pressure set at the patient's diastolic blood pressure. Intervention:Procedure:Sham Remote Ischemic Postconditioning
Intervention Type
Procedure
Intervention Name(s)
remote ischemic postconditioning
Other Intervention Name(s)
PIPostC
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
sham remote ischemic postconditioning
Other Intervention Name(s)
sham PIPostC
Intervention Description
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.
Primary Outcome Measure Information:
Title
Heart Rate Variabilities
Description
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.
Time Frame
at the time points of baseline and 7 and 30 days after treatments
Secondary Outcome Measure Information:
Title
National Institutes of Health Stroke Scale(NIHSS)
Description
National Institutes of Health Stroke Scale(NIHSS)is a commonly used scale for quantifing the impairment caused by a stroke objectively.
Time Frame
at the time points of baseline and 7days after treatments.
Title
Modified Rankin scale(mRS)
Description
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.
Time Frame
at the time points of baseline and 7,30 and 90 days after treatments
Title
Barthel Index(BI)
Description
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.
Time Frame
at the time points of baseline and 7,30 and 90 days after treatments
Other Pre-specified Outcome Measures:
Title
Stroke Recurrence
Description
Stroke recurrence is commonly used to estimate the prognosis of stroke.
Time Frame
90 days after treatments
Title
Mortality
Description
Mortality is commonly used to estimate the prognosis of stroke.
Time Frame
90 days after treatments

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed as ischemic stroke according to the Chinese guideline of diagnosis and treatment of acute ischemic stroke 2010 Age between 18 to 85 years old initial ischemic stroke within 14 days or less. National Institutes of Health Stroke Scale (NIHSS)score 0-15 Modified Rankin Scale(mRS)score 1-4 Informed consent Exclusion Criteria: Intravenous or arterial thrombolysis, or revascularization Acute myocardial infarction,atrial fibrillation,arrhythmia,or cardiogenic cerebral embolism Systolic Blood Pressure(SBP)>200mmHg after medication treatment Plasma fibrinogen>7g/L Upper limb fracture or percutaneous injury Subclavian artery stenosis With severe cardiac,respiratory,hepatic,and renal dysfunction or malignant tumor Simultaneous participation in another interventional study Pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lin WEI, MD
Phone
(08620)81887233
Ext
30812
Email
weilin22@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Miaomiao MO, Bachelor
Phone
(08620)81887233
Ext
34528
Email
momiaomiao11@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lin WEI, MD
Organizational Affiliation
Guangdong Provincial Hospital of Traditional Chinese Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Guangdong Provincial Hospital of Chinese Medicine
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lin WEI, MD
Phone
(08620)81887233
Ext
30812
Email
weilin22@126.com
First Name & Middle Initial & Last Name & Degree
Miaomiao MO, Bachelor
Phone
(08620)81887233
Ext
34528
Email
momiaomiao11@126.com
First Name & Middle Initial & Last Name & Degree
Lin WEI, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Impact of Remote Ischemic Postconditioning on Autonomic Function in Stroke Patients

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