Clinical trial NCT03335111: Influence of Bilateral Arm Ischemic Postconditioning on Clinical Prognosis and Outcome in Acute Ischemic Stroke Patients
Official title: The Influence of Bilateral Arm Ischemic Postconditioning on Clinical Prognosis and Outcome in Patients With Acute Ischemic Stroke（BAIPC）
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Remote Ischemic Postconditioning
Keywords: Remote Ischemic Postconditioning
Peripheral Immunity
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2017-11-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: PREVENTION

Brief summary: 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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes of pheripheral serum cytokines
timeFrame: 0d, 1d and 7-10d
measure: Changes of pheripheral immune cells
timeFrame: 0d, 1d and 7-10d
Secondary outcomes:
measure: Changes of National Institute of Health Stroke scale (NIHSS)
timeFrame: Before BAIPC and after BAIPC for one week
measure: Relapse of ischemic stroke
timeFrame: one year after patients' first stroke
Other outcomes:
Locations:
city: Changchun
country: China
facility: First hospital of Jilin University
state: Jilin
Study officials:
affiliation: The First Hospital of Jilin University
name: Jiachun Feng, MD,Phd
role: STUDY_DIRECTOR
References: