r-tPA Thrombolytic Therapy in Combination With Remote Ischemic Conditioning for Acute Ischemic Stroke Recovery (rtPA-RIC)
19. června 2018 aktualizováno: 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
Přehled studie
Detailní popis
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.
Typ studie
Intervenční
Zápis (Očekávaný)
60
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Beijing
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Beijing, Beijing, Čína, 100053
- Nábor
- Xuanwu Hospital, Capital Medical University
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Kontakt:
- Ruiwen Che, MD
- E-mail: rwcadl@163.com
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Beijing, Beijing, Čína, 101149
- Zatím nenabíráme
- Lu He hospital, Capital Medical University
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Kontakt:
- Geng, MD
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let až 80 let (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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.
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V této studii se kondicionační léčba na dálku skládala z pěti cyklů bilaterální ischemie horní končetiny intervenované reperfuzí, která byla vyvolána dvěma manžetami umístěnými kolem horní části paží a nafouknutá na 200 mm Hg po dobu 5 minut, po kterých následovalo 5 minut reperfuze vypuštěním manžety.
Ostatní jména:
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Žádný zásah: Control group
The participants received r-tPA thrombolytic therapy after diagnosed ischemic stroke.
In addition, all participants receive a standard clinical therapy.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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infarction volume in brain between two groups
Časové okno: measured during 72 h
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assess by MRI-DWI and ADC
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measured during 72 h
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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The score of Modified Rankin scale score
Časové okno: measured at baseline(before RIPC),24 hours, at 5-7 days,30±7 days, 90±7 days
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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
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measured at baseline(before RIPC),24 hours, at 5-7 days,30±7 days, 90±7 days
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proportional of Modified Rankin scale scored 0-1
Časové okno: 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
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measured at baseline(before RIPC),24 hours, at 5-7 days,30±7 days, 90±7 days
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The score of National Institute of Health stroke scale score
Časové okno: measured at baseline(before RIPC),24 hours, at 5-7 days,30±7 days, 90±7 days
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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.
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measured at baseline(before RIPC),24 hours, at 5-7 days,30±7 days, 90±7 days
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The score of Barthel Index(BI)
Časové okno: measured at baseline(before RIPC),24 hours, at 5-7 days,30±7 days, 90±7 days
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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.
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measured at baseline(before RIPC),24 hours, at 5-7 days,30±7 days, 90±7 days
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recurrence of stroke and TIA
Časové okno: changes from baseline(before RIPC) to 90±7 days
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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.
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changes from baseline(before RIPC) to 90±7 days
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death and any other adverse events
Časové okno: changes from baseline(before RIPC) to 90±7 days
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The investigator will record the number.
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changes from baseline(before RIPC) to 90±7 days
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any ICH
Časové okno: changes from baseline(before RIPC) to 90±7 days
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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.
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changes from baseline(before RIPC) to 90±7 days
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Distal radial pulses
Časové okno: during 90 days
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professional doctors will check the distal radial pulses
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during 90 days
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Visual inspection for local edema
Časové okno: during 90 days
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Professional oculists will check the fundus oculi to evaluate whether there is local edema.
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during 90 days
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The number of patients with erythema,and/or skin lesions related to RIC
Časové okno: during 90 days
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Professional doctors will check it and the investigator will record the number.
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during 90 days
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Palpation for tenderness
Časové okno: during 90 days
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Professional doctors will check it.
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during 90 days
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The number of patients not tolerating RIC procedure,and refuse to continue the RIC procedure
Časové okno: during 90 days
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The investigator will record the number.
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during 90 days
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the score of Numeric Rating Scale (NRS)
Časové okno: during 90 days
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The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain.
The score from 0-10. the higher
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during 90 days
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the score of Hamilton Rating Scale for Depression（HAMAD）
Časové okno: change from baseline(before rtPA) to 90 days
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this score was used to provide an indication of depression, and as a guide to evaluate recovery.
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change from baseline(before rtPA) to 90 days
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level of MMP-9
Časové okno: measured at baseline(before RIPC,after rtPA) and 7 days
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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
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measured at baseline(before RIPC,after rtPA) and 7 days
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level of IL-6
Časové okno: measured at baseline(before RIPC,after rtPA) and 7 days
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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
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measured at baseline(before RIPC,after rtPA) and 7 days
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level of HS-CRP
Časové okno: measured at baseline(before RIPC,after rtPA) and 7 days
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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
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measured at baseline(before RIPC,after rtPA) and 7 days
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The level of vascular endothelial growth factor
Časové okno: measured at baseline(before RIPC,after rtPA) and 7 days
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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
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measured at baseline(before RIPC,after rtPA) and 7 days
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
16. června 2018
Primární dokončení (Očekávaný)
1. února 2019
Dokončení studie (Očekávaný)
1. května 2019
Termíny zápisu do studia
První předloženo
28. srpna 2016
První předloženo, které splnilo kritéria kontroly kvality
28. srpna 2016
První zveřejněno (Odhad)
1. září 2016
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
20. června 2018
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
19. června 2018
Naposledy ověřeno
1. června 2018
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- RIC-2016
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
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Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
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