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

NCT03335111 | Unknown DMC

• 1 other identifier: BAIPC
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Remote Ischemic Postconditioning

Keywords

Remote Ischemic Postconditioning; Peripheral Immunity

Outcome Measures

Primary Outcomes (2)

• Changes of pheripheral serum cytokines

  We evaluate the changes of the concentration of serum cytokine (IL-4, IL-6, TNF, et.al) at 0d, 1d, 7-10d respectively to demonstrate whether acute stroke would depress the immune state of patients and wether BAIPC can influence the immune state of patients suffering acute stroke.

  0d, 1d and 7-10d

• Changes of pheripheral immune cells

  We evaluate the frequency of pheripheral immune cells (Th1, Th2, Th17 and Treg cells) at 0d, 1d and 7-10d to demonstrate whether acute stroke would depress the immune state of patients and wether BAIPC can influence the immune state of patients suffering acute stroke.

  0d, 1d and 7-10d

Secondary Outcomes (2)

• Changes of National Institute of Health Stroke scale (NIHSS)

  Before BAIPC and after BAIPC for one week

• Relapse of ischemic stroke

  one year after patients' first stroke

Study Arms (2)

ACI with BAIPC

EXPERIMENTAL

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.

Procedure: Intravenous blood collection

ACI without BAIPC

SHAM COMPARATOR

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.

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

Interventions

Remote Ischemic Conditioning Equipment OTHER

BAIPC is 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) for one week.

ACI without BAIPC

Intravenous blood collection PROCEDURE

Nurses will collect 5 ml intravenous blood with anticoagulant and 5ml total blood at 0d, 1d and 7-10d respectively. The blood samples will be stored for laboratory assay. The blood samples only use in this trial.

ACI with BAIPC; ACI without BAIPC

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients with progressive neurological disease or patients that cannot survive more than 1 year
• 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
• 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
• 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
• 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)
• Patients once with intracranial tumors or brain aneurysm, arteriovenous malformation
• 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.
• Patients with severe blood system disease or severe blood coagulation disfunction , platelet \< 100 x 109 / L;
• 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);
• 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 ;
• Patients with BAIPC contraindications, e.g. severe soft tissue injuries, such as the upper extremity fractures or blood vessels lesions.

Sponsors & Collaborators

• The First Hospital of Jilin University: lead

Study Sites (1)

First hospital of Jilin University

Changchun, Jilin, 130000, China

RECRUITING

Study Officials

• Jiachun Feng, MD,Phd

  The First Hospital of Jilin University

  STUDY DIRECTOR

Central Study Contacts

Jiachun Feng, MD,Phd

CONTACT

fengjcfrank@yahoo.com.cn

Di Ma

CONTACT

madi16@126.com.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients without BAIPC 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' .
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: July 31, 2017
• First Posted: November 7, 2017
• Study Start: November 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2019
• Last Updated: November 14, 2017

Record last verified: 2017-11

Locations

CN (1)