r-tPA Thrombolytic Therapy in Combination With Remote Ischemic Conditioning for Acute Ischemic Stroke Recovery (rtPA-RIC)
19. juni 2018 opdateret af: 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
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
60
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Beijing
-
Beijing, Beijing, Kina, 100053
- Rekruttering
- Xuanwu Hospital, Capital Medical University
-
Kontakt:
- Ruiwen Che, MD
- E-mail: rwcadl@163.com
-
Beijing, Beijing, Kina, 101149
- Ikke rekrutterer endnu
- Lu He hospital, Capital Medical University
-
Kontakt:
- Geng, MD
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 80 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
I denne undersøgelse bestod den fjerntliggende iskæmiske konditioneringsbehandling af fem cyklusser af bilateral iskæmi i øvre lemmer interveneret af reperfusion, som blev induceret af to manchetter placeret omkring henholdsvis overarmene og oppustet til 200 mm Hg i 5 minutter efterfulgt af 5 minutters reperfusion. ved manchet deflation.
Andre navne:
|
|
Ingen indgriben: Control group
The participants received r-tPA thrombolytic therapy after diagnosed ischemic stroke.
In addition, all participants receive a standard clinical therapy.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
infarction volume in brain between two groups
Tidsramme: measured during 72 h
|
assess by MRI-DWI and ADC
|
measured during 72 h
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
The score of Modified Rankin scale score
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: during 90 days
|
professional doctors will check the distal radial pulses
|
during 90 days
|
|
Visual inspection for local edema
Tidsramme: 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
Tidsramme: during 90 days
|
Professional doctors will check it and the investigator will record the number.
|
during 90 days
|
|
Palpation for tenderness
Tidsramme: 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
Tidsramme: during 90 days
|
The investigator will record the number.
|
during 90 days
|
|
the score of Numeric Rating Scale (NRS)
Tidsramme: 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）
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
16. juni 2018
Primær færdiggørelse (Forventet)
1. februar 2019
Studieafslutning (Forventet)
1. maj 2019
Datoer for studieregistrering
Først indsendt
28. august 2016
Først indsendt, der opfyldte QC-kriterier
28. august 2016
Først opslået (Skøn)
1. september 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
20. juni 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. juni 2018
Sidst verificeret
1. juni 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- RIC-2016
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .