r-tPA Thrombolytic Therapy in Combination With Remote Ischemic Conditioning for Acute Ischemic Stroke Recovery (rtPA-RIC)
19 juin 2018 mis à jour par: 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
Aperçu de l'étude
Statut
Inconnue
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Anticipé)
60
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Beijing
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Beijing, Beijing, Chine, 100053
- Recrutement
- Xuanwu Hospital, Capital Medical University
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Contact:
- Ruiwen Che, MD
- E-mail: rwcadl@163.com
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Beijing, Beijing, Chine, 101149
- Pas encore de recrutement
- Lu He hospital, Capital Medical University
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Contact:
- Geng, MD
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 80 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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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Dans cette étude, le traitement de conditionnement ischémique à distance était composé de cinq cycles d'ischémie bilatérale des membres supérieurs intervenus par reperfusion, qui était induite par deux brassards placés autour des bras respectivement et gonflés à 200 mm Hg pendant 5 minutes suivis de 5 minutes de reperfusion par dégonflage du brassard.
Autres noms:
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Aucune intervention: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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infarction volume in brain between two groups
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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The score of Modified Rankin scale score
Délai: 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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proportional of Modified Rankin scale scored 0-1
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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）
Délai: 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.
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change from baseline(before rtPA) to 90 days
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level of MMP-9
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
16 juin 2018
Achèvement primaire (Anticipé)
1 février 2019
Achèvement de l'étude (Anticipé)
1 mai 2019
Dates d'inscription aux études
Première soumission
28 août 2016
Première soumission répondant aux critères de contrôle qualité
28 août 2016
Première publication (Estimation)
1 septembre 2016
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
20 juin 2018
Dernière mise à jour soumise répondant aux critères de contrôle qualité
19 juin 2018
Dernière vérification
1 juin 2018
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- RIC-2016
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .