Clinical trial NCT02777099: Impact of Remote Ischemic Postconditioning on Autonomic Function in Stroke Patients
Official title: Impact of Remote Ischemic Postconditioning on Autonomic Function and Prognosis in Clients With Acute Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ischemic Stroke
Keywords: remote ischemic postconditioning
autonomic function
heart rate variability
acute ischemic stroke
prognosis
Lead sponsor: Guangzhou University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2016-05-19
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Heart Rate Variabilities
timeFrame: at the time points of baseline and 7 and 30 days after treatments
Secondary outcomes:
measure: National Institutes of Health Stroke Scale(NIHSS)
timeFrame: at the time points of baseline and 7days after treatments.
measure: Modified Rankin scale(mRS)
timeFrame: at the time points of baseline and 7,30 and 90 days after treatments
measure: Barthel Index(BI)
timeFrame: at the time points of baseline and 7,30 and 90 days after treatments
Other outcomes:
measure: Stroke Recurrence
timeFrame: 90 days after treatments
measure: Mortality
timeFrame: 90 days after treatments
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial Hospital of Chinese Medicine
state: Guangdong
Study officials:
affiliation: Guangdong Provincial Hospital of Traditional Chinese Medicine
name: Lin WEI, MD
role: STUDY_CHAIR
References: