r-tPA Thrombolytic Therapy in Combination With Remote Ischemic Conditioning for Acute Ischemic Stroke Recovery (rtPA-RIC)
19 giugno 2018 aggiornato da: 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
Panoramica dello studio
Stato
Sconosciuto
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Interventistico
Iscrizione (Anticipato)
60
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
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Beijing
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Beijing, Beijing, Cina, 100053
- Reclutamento
- Xuanwu Hospital, Capital Medical University
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Contatto:
- Ruiwen Che, MD
- Email: rwcadl@163.com
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Beijing, Beijing, Cina, 101149
- Non ancora reclutamento
- Lu He hospital, Capital Medical University
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Contatto:
- Geng, MD
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-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 80 anni (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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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In questo studio, il trattamento di condizionamento ischemico remoto era composto da cinque cicli di ischemia bilaterale dell'arto superiore intervenuta da riperfusione, che è stata indotta da due polsini posizionati rispettivamente attorno alla parte superiore delle braccia e gonfiati a 200 mm Hg per 5 minuti seguiti da 5 minuti di riperfusione mediante sgonfiaggio del bracciale.
Altri nomi:
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Nessun intervento: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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infarction volume in brain between two groups
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
The score of Modified Rankin scale score
Lasso di tempo: 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
Lasso di tempo: 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
|
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The score of National Institute of Health stroke scale score
Lasso di tempo: 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.
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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)
Lasso di tempo: 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.
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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
Lasso di tempo: 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.
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changes from baseline(before RIPC) to 90±7 days
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death and any other adverse events
Lasso di tempo: changes from baseline(before RIPC) to 90±7 days
|
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
Lasso di tempo: 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.
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changes from baseline(before RIPC) to 90±7 days
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Distal radial pulses
Lasso di tempo: during 90 days
|
professional doctors will check the distal radial pulses
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during 90 days
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Visual inspection for local edema
Lasso di tempo: 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
Lasso di tempo: during 90 days
|
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
Lasso di tempo: during 90 days
|
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
Lasso di tempo: during 90 days
|
The investigator will record the number.
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during 90 days
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the score of Numeric Rating Scale (NRS)
Lasso di tempo: 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
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during 90 days
|
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the score of Hamilton Rating Scale for Depression（HAMAD）
Lasso di tempo: 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
Lasso di tempo: 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
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measured at baseline(before RIPC,after rtPA) and 7 days
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level of IL-6
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
16 giugno 2018
Completamento primario (Anticipato)
1 febbraio 2019
Completamento dello studio (Anticipato)
1 maggio 2019
Date di iscrizione allo studio
Primo inviato
28 agosto 2016
Primo inviato che soddisfa i criteri di controllo qualità
28 agosto 2016
Primo Inserito (Stima)
1 settembre 2016
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
20 giugno 2018
Ultimo aggiornamento inviato che soddisfa i criteri QC
19 giugno 2018
Ultimo verificato
1 giugno 2018
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- RIC-2016
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .