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r-tPA Thrombolytic Therapy in Combination With Remote Ischemic Conditioning for Acute Ischemic Stroke Recovery (rtPA-RIC)

19 juni 2018 bijgewerkt door: Ji Xunming,MD,PhD, Capital Medical University

Intravenous Rt-PA Thrombolysis Combined With Remote Ischemic Post-Conditioning for Acute Ischemic Stroke Patients

to detect the efficiency and safety of intravenous rtPA combined with RIPC in acute ischemic stroke patients

Studie Overzicht

Toestand

Onbekend

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Remote ischemic post-conditioning, which consists of several brief cycles of intermittent ischemia-reperfusion of the arm or leg, may potentially confer a powerful systemic protection against prolonged ischemia in a distant organ. Numerous reports have confirmed it strongest endogenous neuroprotection against brain injury after stroke. Ren et al demonstrated that remote ischemic post-conditioning (RIPC) performed in the hind limbs can not only significantly reduce the stroke volume within 3 hours in rat model, but also ameliorate the outcome of the behavioral test. A long-term repeated RIPC therapy can also help improving neurological functions. A combination of RIPC and tPA can help with neuroprotection which improves the neurological functions. Thus, it is meaningful to transform these basic experimental results to the clinical treatment. In the RECAST-1 trial, RIC has shown it safety and efficiency in AIS patients without tPA. However, there is no further explanation for the patients with IVT. Thus, in this study, we aim to demonstrate the efficiency and safety of RIPC in AIS patients performed rt-PA within 4.5 hours.

Studietype

Ingrijpend

Inschrijving (Verwacht)

60

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

  • China
    • Beijing
      • Beijing, Beijing, China, 100053
        • Werving
        • Xuanwu Hospital, Capital Medical University
        • Contact:
      • Beijing, Beijing, China, 101149
        • Nog niet aan het werven
        • Lu He hospital, Capital Medical University
        • Contact:
          • Geng, MD

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:

  • Male or female, age≥18;
  • Clinical sign and symptoms consistent with the diagnosis of an acute ischemic stroke, onset of stroke symptoms within 4.5 h before initiation of intravenous rt-PA thrombolytic therapy;
  • Baseline National Institutes of Health Stroke Scale (NIHSS) score of 4-15 (assessed before intravenous alteplase), mRS ≤1 before onset of stroke symptom;
  • No contraindication for MRI.
  • Informed consent obtained

Exclusion Criteria:

  • Cardioembolism；
  • Contraindication for remote ischemic conditioning: severe soft tissue injury, fracture, or peripheral vascular disease in the upper limbs;
  • Life expectancy < 1 year;
  • Pregnant or breast-feeding women;
  • Unwilling to be followed up or poor compliance for treatment; (5) Patients being enrolled or having been enrolled in other clinical trial within 3 months prior to this clinical trial.

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: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: RIC group
The upper limb ischemic conditioning is composed of five cycles of bilateral upper limb ischemia intervened by reperfusion, which is induced by two cuff placed around the upper arms respectively and inflated to 200 mm Hg for 5 minutes followed by 5 minutes of reperfusion by cuff deflation. This therapy started within 2 hours after r-tPA thrombolytic therapy. In addition, all participants receive a standard clinical therapy.
Apparaat: ischemische conditionering
In deze studie bestond de ischemische conditioneringsbehandeling op afstand uit vijf cycli van bilaterale ischemie van de bovenste ledematen onderbroken door reperfusie, die werd geïnduceerd door respectievelijk twee manchetten rond de bovenarmen te plaatsen en opgeblazen tot 200 mm Hg gedurende 5 minuten, gevolgd door 5 minuten reperfusie. door het leeglopen van de manchet.
Andere namen:
  • Doctoraat, IPC-906
Geen tussenkomst: Control group
The participants received r-tPA thrombolytic therapy after diagnosed ischemic stroke. In addition, all participants receive a standard clinical therapy.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
infarction volume in brain between two groups
Tijdsspanne: measured during 72 h
assess by MRI-DWI and ADC
measured during 72 h

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
The score of Modified Rankin scale score
Tijdsspanne: measured at baseline(before RIPC),24 hours, at 5-7 days,30±7 days, 90±7 days
The Modified Rankin Scale Score (mRS) is the most comprehensive and most widely used primary outcome measurement to assess the neurological functional disability in contemporary acute stroke trials. The mRS is an ordinal, graded interval scale that assigns patients among 7 global disability levels, which ranges from 0 (no symptom) to 5 (severe disability) and 6 (death). We will use mRS to evaluate the degree of disability or dependence during daily activities. The mRS will be assessed by certified study investigator, who is blinded to the treatment assignment, at 90 days postoperation. The distribution of mRS will be compared between groups
measured at baseline(before RIPC),24 hours, at 5-7 days,30±7 days, 90±7 days
proportional of Modified Rankin scale scored 0-1
Tijdsspanne: measured at baseline(before RIPC),24 hours, at 5-7 days,30±7 days, 90±7 days
The Modified Rankin Scale Score (mRS) is the most comprehensive and most widely used primary outcome measurement to assess the neurological functional disability in contemporary acute stroke trials. The mRS is an ordinal, graded interval scale that assigns patients among 7 global disability levels, which ranges from 0 (no symptom) to 5 (severe disability) and 6 (death). We will use mRS to evaluate the degree of disability or dependence during daily activities. The mRS will be assessed by certified study investigator, who is blinded to the treatment assignment, at 90 days postoperation. The distribution of mRS will be compared between groups
measured at baseline(before RIPC),24 hours, at 5-7 days,30±7 days, 90±7 days
The score of National Institute of Health stroke scale score
Tijdsspanne: measured at baseline(before RIPC),24 hours, at 5-7 days,30±7 days, 90±7 days
National Institute of Health Stroke Scale (NIHSS) is considered as a standardized assessment of neurological functions in the acute phase of stroke, and it is generally used to quantify patient's neurological impairments on 15 items in 11 fields of different neurological status.The score of the scale ranges from 0 to 42.And higher score indicates worse neurological function.
measured at baseline(before RIPC),24 hours, at 5-7 days,30±7 days, 90±7 days
The score of Barthel Index(BI)
Tijdsspanne: measured at baseline(before RIPC),24 hours, at 5-7 days,30±7 days, 90±7 days
the BI is used to measure performance in activities of daily living.The score of the scale ranges from 0 to 100. And lower score indicates worse activities of daily living.
measured at baseline(before RIPC),24 hours, at 5-7 days,30±7 days, 90±7 days
recurrence of stroke and TIA
Tijdsspanne: changes from baseline(before RIPC) to 90±7 days
Stroke recurrence was defined as sudden functional deterioration in neurologic status with a decrease of 4 or more in the NIHSS, or a new stroke lesion on MRI/DWI located at the territory of the affected intracranial arteries.
changes from baseline(before RIPC) to 90±7 days
death and any other adverse events
Tijdsspanne: changes from baseline(before RIPC) to 90±7 days
The investigator will record the number.
changes from baseline(before RIPC) to 90±7 days
any ICH
Tijdsspanne: changes from baseline(before RIPC) to 90±7 days
Head computed tomography or magnetic reasoning imaging (MRI) scan will be performed to confirm intracerebral hemorrhage, and the imaging will be evaluated by two independent neuroradiologists who are blinded to the study assignment.
changes from baseline(before RIPC) to 90±7 days
Distal radial pulses
Tijdsspanne: during 90 days
professional doctors will check the distal radial pulses
during 90 days
Visual inspection for local edema
Tijdsspanne: during 90 days
Professional oculists will check the fundus oculi to evaluate whether there is local edema.
during 90 days
The number of patients with erythema,and/or skin lesions related to RIC
Tijdsspanne: during 90 days
Professional doctors will check it and the investigator will record the number.
during 90 days
Palpation for tenderness
Tijdsspanne: during 90 days
Professional doctors will check it.
during 90 days
The number of patients not tolerating RIC procedure,and refuse to continue the RIC procedure
Tijdsspanne: during 90 days
The investigator will record the number.
during 90 days
the score of Numeric Rating Scale (NRS)
Tijdsspanne: during 90 days
The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. The score from 0-10. the higher
during 90 days
the score of Hamilton Rating Scale for Depression（HAMAD）
Tijdsspanne: change from baseline(before rtPA) to 90 days
this score was used to provide an indication of depression, and as a guide to evaluate recovery.
change from baseline(before rtPA) to 90 days
level of MMP-9
Tijdsspanne: measured at baseline(before RIPC,after rtPA) and 7 days
Blood samples will be drawn from cubital vein to test these biomarkers.These samples will be centrifuged immediately after collection and stored at - 80 until batch evaluation
measured at baseline(before RIPC,after rtPA) and 7 days
level of IL-6
Tijdsspanne: measured at baseline(before RIPC,after rtPA) and 7 days
Blood samples will be drawn from cubital vein to test these biomarkers.These samples will be centrifuged immediately after collection and stored at - 80 until batch evaluation
measured at baseline(before RIPC,after rtPA) and 7 days
level of HS-CRP
Tijdsspanne: measured at baseline(before RIPC,after rtPA) and 7 days
Blood samples will be drawn from cubital vein to test these biomarkers.These samples will be centrifuged immediately after collection and stored at - 80 until batch evaluation
measured at baseline(before RIPC,after rtPA) and 7 days
The level of vascular endothelial growth factor
Tijdsspanne: measured at baseline(before RIPC,after rtPA) and 7 days
Blood samples will be drawn from cubital vein to test these biomarkersThese samples will be centrifuged immediately after collection and stored at - 80 until batch evaluation
measured at baseline(before RIPC,after rtPA) and 7 days

Medewerkers en onderzoekers

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

Sponsor

Capital Medical 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 (Werkelijk)

16 juni 2018

Primaire voltooiing (Verwacht)

1 februari 2019

Studie voltooiing (Verwacht)

1 mei 2019

Studieregistratiedata

Eerst ingediend

28 augustus 2016

Eerst ingediend dat voldeed aan de QC-criteria

28 augustus 2016

Eerst geplaatst (Schatting)

1 september 2016

Updates van studierecords

Laatste update geplaatst (Werkelijk)

20 juni 2018

Laatste update ingediend die voldeed aan QC-criteria

19 juni 2018

Laatst geverifieerd

1 juni 2018

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • RIC-2016

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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