- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02886390
r-tPA Thrombolytic Therapy in Combination With Remote Ischemic Conditioning for Acute Ischemic Stroke Recovery (rtPA-RIC)
19. Juni 2018 aktualisiert von: 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
Studienübersicht
Status
Unbekannt
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Voraussichtlich)
60
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
Beijing
-
Beijing, Beijing, China, 100053
- Rekrutierung
- Xuanwu Hospital, Capital Medical University
-
Kontakt:
- Ruiwen Che, MD
- E-Mail: rwcadl@163.com
-
Beijing, Beijing, China, 101149
- Noch keine Rekrutierung
- Lu He hospital, Capital Medical University
-
Kontakt:
- Geng, MD
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 80 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
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.
|
In dieser Studie bestand die ischämische Fernkonditionierungsbehandlung aus fünf Zyklen bilateraler Ischämie der oberen Extremitäten, interveniert durch Reperfusion, die durch zwei Manschetten induziert wurde, die jeweils um die Oberarme gelegt und für 5 Minuten auf 200 mm Hg aufgeblasen wurden, gefolgt von 5 Minuten Reperfusion durch Manschettendeflation.
Andere Namen:
|
Kein Eingriff: Control group
The participants received r-tPA thrombolytic therapy after diagnosed ischemic stroke.
In addition, all participants receive a standard clinical therapy.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
infarction volume in brain between two groups
Zeitfenster: measured during 72 h
|
assess by MRI-DWI and ADC
|
measured during 72 h
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
The score of Modified Rankin scale score
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: during 90 days
|
professional doctors will check the distal radial pulses
|
during 90 days
|
Visual inspection for local edema
Zeitfenster: 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
Zeitfenster: during 90 days
|
Professional doctors will check it and the investigator will record the number.
|
during 90 days
|
Palpation for tenderness
Zeitfenster: 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
Zeitfenster: during 90 days
|
The investigator will record the number.
|
during 90 days
|
the score of Numeric Rating Scale (NRS)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
16. Juni 2018
Primärer Abschluss (Voraussichtlich)
1. Februar 2019
Studienabschluss (Voraussichtlich)
1. Mai 2019
Studienanmeldedaten
Zuerst eingereicht
28. August 2016
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
28. August 2016
Zuerst gepostet (Schätzen)
1. September 2016
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
20. Juni 2018
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
19. Juni 2018
Zuletzt verifiziert
1. Juni 2018
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- RIC-2016
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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