r-tPA Thrombolytic Therapy in Combination With Remote Ischemic Conditioning for Acute Ischemic Stroke Recovery (rtPA-RIC)
19 de junio de 2018 actualizado 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
Descripción general del estudio
Estado
Desconocido
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Intervencionista
Inscripción (Anticipado)
60
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Xunming Ji, MD. PhD
- Número de teléfono: +86-10-83198952
- Correo electrónico: jixm@ccmu.edu.cn
Ubicaciones de estudio
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Beijing
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Beijing, Beijing, Porcelana, 100053
- Reclutamiento
- Xuanwu Hospital, Capital Medical University
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Contacto:
- Ruiwen Che, MD
- Correo electrónico: rwcadl@163.com
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Beijing, Beijing, Porcelana, 101149
- Aún no reclutando
- Lu He hospital, Capital Medical University
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Contacto:
- Geng, MD
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 80 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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.
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En este estudio, el tratamiento de acondicionamiento isquémico a distancia estuvo compuesto por cinco ciclos de isquemia bilateral de miembros superiores intervenidos por reperfusión, que fue inducida por dos manguitos colocados alrededor de la parte superior de los brazos respectivamente e inflados a 200 mm Hg durante 5 minutos seguidos de 5 minutos de reperfusión. por desinflado del manguito.
Otros nombres:
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Sin intervención: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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infarction volume in brain between two groups
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The score of Modified Rankin scale score
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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）
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
16 de junio de 2018
Finalización primaria (Anticipado)
1 de febrero de 2019
Finalización del estudio (Anticipado)
1 de mayo de 2019
Fechas de registro del estudio
Enviado por primera vez
28 de agosto de 2016
Primero enviado que cumplió con los criterios de control de calidad
28 de agosto de 2016
Publicado por primera vez (Estimar)
1 de septiembre de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
20 de junio de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
19 de junio de 2018
Última verificación
1 de junio de 2018
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- RIC-2016
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre condicionamiento isquémico
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