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

Guangzhou University of Traditional Chinese Medicine

Status: Unknown

Conditions: Ischemic Stroke

Treatments: Procedure: remote ischemic postconditioning; Procedure: sham remote ischemic postconditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT02777099

2014A020212455

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups

RIPostC

Experimental group

Description:

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

Treatment:

Procedure: remote ischemic postconditioning

sham RIPostC

Sham Comparator group

Description:

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

Treatment:

Procedure: sham remote ischemic postconditioning