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

September 27, 2017 updated by: Guangzhou University of Traditional Chinese Medicine

Impact of Remote Ischemic Postconditioning on Autonomic Function and Prognosis in Clients With Acute Ischemic Stroke

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Recruiting
        • Guangdong Provincial Hospital of Chinese Medicine
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lin WEI, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RIPostC
Receiving RIPostC with pressure set at 200 mmHg. Intervention:Procedure:Remote Ischemic Postconditioning
Procedure: remote ischemic postconditioning
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.
Other Names:
  • PIPostC
Sham Comparator: sham RIPostC

Receiving sham RIPostC with pressure set at the patient's diastolic blood pressure.

Intervention:Procedure:Sham Remote Ischemic Postconditioning
Procedure: sham remote ischemic postconditioning
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.
Other Names:
  • sham PIPostC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart Rate Variabilities
Time Frame: at the time points of baseline and 7 and 30 days after treatments
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.
at the time points of baseline and 7 and 30 days after treatments

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
National Institutes of Health Stroke Scale(NIHSS)
Time Frame: at the time points of baseline and 7days after treatments.
National Institutes of Health Stroke Scale(NIHSS)is a commonly used scale for quantifing the impairment caused by a stroke objectively.
at the time points of baseline and 7days after treatments.
Modified Rankin scale(mRS)
Time Frame: at the time points of baseline and 7,30 and 90 days after treatments
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.
at the time points of baseline and 7,30 and 90 days after treatments
Barthel Index(BI)
Time Frame: at the time points of baseline and 7,30 and 90 days after treatments
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.
at the time points of baseline and 7,30 and 90 days after treatments

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stroke Recurrence
Time Frame: 90 days after treatments
Stroke recurrence is commonly used to estimate the prognosis of stroke.
90 days after treatments
Mortality
Time Frame: 90 days after treatments
Mortality is commonly used to estimate the prognosis of stroke.
90 days after treatments

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangzhou University of Traditional Chinese Medicine

Investigators

  • Study Chair: Lin WEI, MD, Guangdong Provincial Hospital of Traditional Chinese Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

February 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

May 17, 2016

First Submitted That Met QC Criteria

May 18, 2016

First Posted (Estimate)

May 19, 2016

Study Record Updates

Last Update Posted (Actual)

September 29, 2017

Last Update Submitted That Met QC Criteria

September 27, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014A020212455

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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