r-tPA Thrombolytic Therapy in Combination With Remote Ischemic Conditioning for Acute Ischemic Stroke Recovery (rtPA-RIC)
19 de junho de 2018 atualizado por: 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
Visão geral do estudo
Status
Desconhecido
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Antecipado)
60
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
-
Beijing
-
Beijing, Beijing, China, 100053
- Recrutamento
- Xuanwu Hospital, Capital Medical University
-
Contato:
- Ruiwen Che, MD
- E-mail: rwcadl@163.com
-
Beijing, Beijing, China, 101149
- Ainda não está recrutando
- Lu He hospital, Capital Medical University
-
Contato:
- Geng, MD
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 80 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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.
|
Neste estudo, o tratamento de condicionamento isquêmico remoto foi composto por cinco ciclos de isquemia bilateral do membro superior intervencionada por reperfusão, que foi induzida por dois manguitos colocados ao redor dos braços, respectivamente, e inflados a 200 mm Hg por 5 minutos, seguidos de 5 minutos de reperfusão pela deflação do manguito.
Outros nomes:
|
|
Sem intervenção: Control group
The participants received r-tPA thrombolytic therapy after diagnosed ischemic stroke.
In addition, all participants receive a standard clinical therapy.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
infarction volume in brain between two groups
Prazo: measured during 72 h
|
assess by MRI-DWI and ADC
|
measured during 72 h
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
The score of Modified Rankin scale score
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: during 90 days
|
professional doctors will check the distal radial pulses
|
during 90 days
|
|
Visual inspection for local edema
Prazo: 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
Prazo: during 90 days
|
Professional doctors will check it and the investigator will record the number.
|
during 90 days
|
|
Palpation for tenderness
Prazo: 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
Prazo: during 90 days
|
The investigator will record the number.
|
during 90 days
|
|
the score of Numeric Rating Scale (NRS)
Prazo: 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）
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
16 de junho de 2018
Conclusão Primária (Antecipado)
1 de fevereiro de 2019
Conclusão do estudo (Antecipado)
1 de maio de 2019
Datas de inscrição no estudo
Enviado pela primeira vez
28 de agosto de 2016
Enviado pela primeira vez que atendeu aos critérios de CQ
28 de agosto de 2016
Primeira postagem (Estimativa)
1 de setembro de 2016
Atualizações de registro de estudo
Última Atualização Postada (Real)
20 de junho de 2018
Última atualização enviada que atendeu aos critérios de controle de qualidade
19 de junho de 2018
Última verificação
1 de junho de 2018
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- RIC-2016
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .