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

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ClinicalTrials.gov Identifier: NCT03335111
Recruitment Status : Unknown
Verified November 2017 by The First Hospital of Jilin University.
Recruitment status was:  Recruiting
First Posted : November 7, 2017
Last Update Posted : November 14, 2017
Sponsor:
Information provided by (Responsible Party):
The First Hospital of Jilin University

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

Condition or disease Intervention/treatment Phase
Remote Ischemic Postconditioning Other: Remote Ischemic Conditioning Equipment Procedure: Intravenous blood collection Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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).
Masking: Single (Participant)
Masking Description: 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' .
Primary Purpose: Prevention
Official Title: The Influence of Bilateral Arm Ischemic Postconditioning on Clinical Prognosis and Outcome in Patients With Acute Ischemic Stroke(BAIPC)
Study Start Date : November 2016
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2019

Arm Intervention/treatment
Experimental: ACI with BAIPC
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
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.

Sham Comparator: ACI without BAIPC
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
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.

Procedure: Intravenous blood collection
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.




Primary Outcome Measures :
  1. Changes of pheripheral serum cytokines [ Time Frame: 0d, 1d and 7-10d ]
    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.

  2. Changes of pheripheral immune cells [ Time Frame: 0d, 1d and 7-10d ]
    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.


Secondary Outcome Measures :
  1. Changes of National Institute of Health Stroke scale (NIHSS) [ Time Frame: Before BAIPC and after BAIPC for one week ]
    We evaluate patients NIHSS before BAIPC and after BAIPC for one week to see wether BAIPC could improve the short term prognosis of patient.Scoring Definitions include level of consciousness, visual field, facial palsy,limb motor,sensory ,language,and dysarthria .The NIHSS captures both motor and non-motor impairments of stroke, and provides a good overview of people's deficits.NIHSS ranges from 0 to 42, with high scores corresponding to increased severity of stroke with worse prognosis.

  2. Relapse of ischemic stroke [ Time Frame: one year after patients' first stroke ]
    We observe the relapse of ischemic stroke after one yearto see wether BAIPC could improve the long term prognosis of patient.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03335111


Contacts
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Contact: Jiachun Feng, MD,Phd fengjcfrank@yahoo.com.cn
Contact: Di Ma madi16@126.com.cn

Locations
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China, Jilin
First hospital of Jilin University Recruiting
Changchun, Jilin, China, 130000
Contact: Jiachun Feng    86+18186871276      
Sponsors and Collaborators
The First Hospital of Jilin University
Investigators
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Study Director: Jiachun Feng, MD,Phd The First Hospital of Jilin University
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Responsible Party: The First Hospital of Jilin University
ClinicalTrials.gov Identifier: NCT03335111    
Other Study ID Numbers: BAIPC
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: November 2017
Keywords provided by The First Hospital of Jilin University:
Remote Ischemic Postconditioning
Peripheral Immunity
Additional relevant MeSH terms:
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Ischemic Stroke
Ischemia
Pathologic Processes
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases