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

10 november 2017 bijgewerkt door: The First Hospital of Jilin University

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

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

Studie Overzicht

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Verwacht)

100

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

    • Jilin
      • Changchun, Jilin, China, 130000
        • Werving
        • First Hospital of Jilin University
        • Contact:
          • Jiachun Feng
          • Telefoonnummer: 86+18186871276

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 80 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
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-vergelijker: 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.
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.
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Changes of pheripheral serum cytokines
Tijdsspanne: 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.
0d, 1d and 7-10d
Changes of pheripheral immune cells
Tijdsspanne: 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.
0d, 1d and 7-10d

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Changes of National Institute of Health Stroke scale (NIHSS)
Tijdsspanne: 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.
Before BAIPC and after BAIPC for one week
Relapse of ischemic stroke
Tijdsspanne: 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.
one year after patients' first stroke

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Studie directeur: Jiachun Feng, MD,Phd, The First Hospital of Jilin University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 november 2016

Primaire voltooiing (Verwacht)

1 januari 2018

Studie voltooiing (Verwacht)

1 januari 2019

Studieregistratiedata

Eerst ingediend

31 juli 2017

Eerst ingediend dat voldeed aan de QC-criteria

2 november 2017

Eerst geplaatst (Werkelijk)

7 november 2017

Updates van studierecords

Laatste update geplaatst (Werkelijk)

14 november 2017

Laatste update ingediend die voldeed aan QC-criteria

10 november 2017

Laatst geverifieerd

1 november 2017

Meer informatie

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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