Influence of Bilateral Arm Ischemic Postconditioning on Clinical Prognosis and Outcome in Acute Ischemic Stroke Patients (BAIPC)

Jilin University

Status: Unknown

Conditions: Remote Ischemic Postconditioning

Treatments: Other: Remote Ischemic Conditioning Equipment; Procedure: Intravenous blood collection

Study type: Interventional

Funder types: Other

Identifiers

NCT03335111

BAIPC

Details and patient eligibility

About

Influence of bilateral arm ischemic postconditioning （BAIPC）on the injury and protective blood markers and the clinical prognosis and outcome in patients with acute ischemic stroke

Full description

In this study, we explore the influence of bilateral arm ischemic postconditioning (BAIPC) to patients with anterior circulation acute ischemic stroke. Patients with anterior circulation acute ischemic stroke are enrolled and divided into control group and experimental group. Patients in experimental group are administrated with BAIPC within 3 days from the occurrence of stroke. The National Institute of Health stroke scale (NIHSS) will be evaluated at different time point to analyze the influence of BAIPC to acute ischemic patients. The level of IL-4, IL-6，TNF-α as well as the frequency of different sub-populations T cells in the blood at different time point will be detected to explore the possible mechanism of BAIPC protective function.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with ischemic cerebral stroke within 72 hours, NIHSS score between 4 to 15 points;
2. Age between 18-80 years ,gender not limited;
3. freely given informed consent.

Exclusion criteria

1. Patients with progressive neurological disease or patients that cannot survive more than 1 year
2. Patients suspected intracranial artery dissection, moyamoya disease, any known vascular inflammatory disease, radioactive vascular lesions, fibromuscular dysplasia, sickle cell disease, tumor, reversible cerebral vascular contraction and reversible posterior leukoencephalopathy syndrome
3. Patients with Cardioembolism , such as rheumatic mitral or aortic stenosis, artificial heart valve, sick sinus syndrome, left atrial myxoma, left ventricular mural thrombus or valvular vegetations, congestive heart failure, bacterial endocarditis
4. Patients with uncontrollable severe hypertension (after drug treatment, systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg) Patients with subclavian artery stenosis 50% or higher or subclavian artery steal blood syndrome and upper limb arterial occlusion
5. Patients with serum Aspertate aminotransferase or Alanine transaminase concentration 3 times higher than normal ceiling Patients that Creatinine clearance < 0.6 ml/s or serum creatinine >265 umol/l (> 3.0 mg/dl)
6. Patients once with intracranial tumors or brain aneurysm, arteriovenous malformation
7. Patients with intracranial bleeding occurred within 90 days (parenchymal hemorrhage, subarachnoid hemorrhage, subdural out/epidural blood), retinal hemorrhage or visceral bleeding occurred within 30 days.
8. Patients with severe blood system disease or severe blood coagulation disfunction , platelet < 100 x 109 / L;
9. Patients that received major surgery 30 days before or is expected to wthin 12 months (including femoral artery, heart, the aorta or the carotid surgery);
10. Patients whose Target lesion blood vessel had received a stent implantation, angioplasty or other medical treatment, or is expected to above treatments witnin 12 months ;
11. Patients with BAIPC contraindications, e.g. severe soft tissue injuries, such as the upper extremity fractures or blood vessels lesions.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

ACI with BAIPC

Experimental group

Description:

Beside of routine treatment for Anterior circulation infarction(ACI) patients, BAIPC group patients are admistrated by 5 cycles extremities ischemia (5-minute blood-pressure cuff inflation up to 50 mmHg higher than baseline, followed by 5-minute cuff deflation). All subjects will take BAIPC for 1 week using 'Remote Ischemic Conditioning Equipment' .Intravenous blood collection with anticoagulant and 5ml total blood will be administered at 0d, 1d and 7-10d respectively. The blood samples will be stored for laboratory assay. The blood samples only use in this trial.

Treatment:

Procedure: Intravenous blood collection

ACI without BAIPC

Sham Comparator group

Description:

ACI patients in this group only recieve routine treatment for ischemic stroke and are admistrated by 5 cycles extremities ischemia (5-minute blood-pressure cuff inflation using pressure 0 mmHg , followed by 5-minute cuff deflation). All subjects will take BAIPC for 1 week using 'Remote Ischemic Conditioning Equipment' .Intravenous blood collection with anticoagulant and 5ml total blood will be administered at 0d, 1d and 7-10d respectively. The blood samples will be stored for laboratory assay. The blood samples only use in this trial.

Treatment:

Procedure: Intravenous blood collection

Other: Remote Ischemic Conditioning Equipment