Impact of Remote Ischemic Postconditioning on Autonomic Function in Stroke Patients

Ischemic Stroke Clinical Trial

— IRAS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02777099
• Other study ID #: 2014A020212455
• Status: Recruiting
• Phase: N/A
• First received: May 17, 2016
• Last updated: September 27, 2017
• Start date: January 2016
• Est. completion date: December 2018

Study information

• Verified date: September 2017
• Source: Guangzhou University of Traditional Chinese Medicine
• Contact: Lin WEI, MD
• Phone: (08620)81887233
• Email: weilin22[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Guangdong Provincial Hospital of Chinese Medicine	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Stroke Recurrence	Stroke recurrence is commonly used to estimate the prognosis of stroke.	90 days after treatments
Other	Mortality	Mortality is commonly used to estimate the prognosis of stroke.	90 days after treatments
Primary	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.	at the time points of baseline and 7 and 30 days after treatments
Secondary	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.	at the time points of baseline and 7days after treatments.
Secondary	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.	at the time points of baseline and 7,30 and 90 days after treatments
Secondary	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.	at the time points of baseline and 7,30 and 90 days after treatments