- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00336596
Ultrasound Enhanced Thrombolytic Therapy of Middle Cerebral Artery Occlusion
25. april 2007 opdateret af: University of Zurich
Transcranial Ultrasound Enhanced Thrombolysis (TRUST)
The purpose of the present, randomized, controlled multicenter phase III trial is to investigate the safety and efficacy of continuous 1-hour insonation of occluded middle cerebral artery with 2 MHz TCCS in stroke patients treated with intravenous tissue plasminogen activator (t-PA) within 3 hours after symptom onset.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Thrombolysis with intravenous(iv) tissue plasminogen activator (t-PA) is the only effective and approved therapy for acute ischemic stroke.
The most frequent cause of ischemic stroke is thrombosis of the middle cerebral artery (MCA).
Preliminary in vitro, animal and human studies suggest that ultrasound accelerates thrombolysis induced by t-PA, and recanalization of acute MCA occlusion due to thrombolysis is an independent predictor of good clinical outcome.
Thus, insonation of an occluded MCA through the temporal bone in stroke patients who are treated with iv t-PA might enhance recanalization and improve clinical outcome.
The present prospective, randomized, controlled multicenter pilot study will investigate the safety and efficacy of continuous 1-hour insonation of the occluded MCA with 2 MHz transcranial color duplex sonography in patients with ischemic stroke treated with iv t-PA within 3 hours after symptom onset.
It is planned to randomize 400 patients in 6 Swiss centers during an enrolment period of 33 months with an individual follow up of 3 months.
The study endpoints include safety and efficacy assessments.
The primary safety endpoint is to determine the rate of symptomatic intracranial hemorrhage (ICH) in both treatment groups.
The primary efficacy endpoint is to determine whether a good functional outcome (modified Rankin scale, mRs, score of 0-2) differs between both treatment groups.
Secondary endpoints include (1) asymptomatic ICH occuring during or within the first 24-48 hours after t-PA infusion, (2) early clinical recovery by 10 or more National Institute of Health Stroke Scale (NIHSS) points or dramatic recovery (total NIHSS score of 3 or less) at 24-48 hours after t-PA infusion, (3) mean mRS score at 90 days after t-PA infusion, (4) death occuring during the study period, and (5) recanalization at 24-48 hours after t-PA infusion.
Undersøgelsestype
Interventionel
Tilmelding
400
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Ralf W Baumgartner, MD
- Telefonnummer: +41 1 255 56 86
- E-mail: ralf.baumgartner@usz.ch
Studiesteder
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-
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Aarau, Schweiz
- Rekruttering
- Kantonsspital Aarau, Department of Neurology
-
Kontakt:
- Hansjörg Hungerbühler, MD
- Telefonnummer: +41 62 838 66 75
- E-mail: hansjoerg.hungerbuehler@ksa.ch
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Ledende efterforsker:
- Hansjörg Hungerbühler, MD
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Basel, Schweiz
- Rekruttering
- University Hospital of Basel, Department of Neurology
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Kontakt:
- Stefan Engelter, MD
- Telefonnummer: +41 61 265 25 25
- E-mail: sengelter@uhbs.ch
-
Ledende efterforsker:
- Philippe Lyrer, MD
-
Ledende efterforsker:
- Stefan Engelter, MD
-
Bern, Schweiz
- Rekruttering
- University hospital of Bern, Department of Neurology
-
Kontakt:
- Marcel Arnold, MD
- Telefonnummer: +41 31 632 33 32
- E-mail: marcel.arnold@insel.ch
-
Ledende efterforsker:
- H.-P. Mattle, MD
-
Ledende efterforsker:
- Marcel Arnold, MD
-
Geneva, Schweiz
- Rekruttering
- University Hospital of Geneva, Department of Neurology
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Kontakt:
- Roman Sztajzel, MD
- Telefonnummer: +41 22 372 83 10
- E-mail: Roman.Sztajzel@hcuge.ch
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Ledende efterforsker:
- Roman Sztajzel, MD
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Lausanne, Schweiz
- Rekruttering
- University Hospital of Lausanne, Department of Neurology
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Kontakt:
- Patrik Michel, MD
- Telefonnummer: +41 21 314 11 85
- E-mail: patrik.michel@chuv.hospvd.ch
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Ledende efterforsker:
- Patrik Michel, MD
-
Zurich, Schweiz, 8091
- Rekruttering
- University Hospital of Zurich, Department of Neurology
-
Kontakt:
- Ralf W Baumgartner, MD
- Telefonnummer: +41 1 255 56 86
- E-mail: ralf.baumgartner@usz.ch
-
Kontakt:
- Dimitrios Georgiadis, MD
- E-mail: dimitrios.georgiadis@usz.ch
-
Ledende efterforsker:
- Ralf W Baumgartner, MD
-
Ledende efterforsker:
- Dimitrios Georgiadis, MD
-
Underforsker:
- Hakan Sarikaya, MD
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- acute ischemic stroke in the MCA territory according to clinical and cranial computed tomography (CT) or cranial MR imaging (MRI) findings
- patient undergoing iv thrombolysis with t-PA within 3 hours after stroke onset
- Occlusion of sphenoidal (M1) or insular (M2) segment of the MCA at CT (CTA), MR (MRA) or catheter (CA) angiography
- appropriate temporal bony window without echocontrast agents for insonation with TCCS
- full functional independence prior to present stroke (mRS 0-1), use of a cane for walking due to comorbid condition is acceptable
- written informed consent, signed and dated by the subject (or subject's authorized representative, if allowed by local laws) and by the person obtaining the consent, indicating agreement to comply with all protocol-specific procedures
Exclusion Criteria:
- unconsciousness (more than 2 points on item 1a on NIHSS)
- history of intracranial hemorrhage, arteriovenous malformation or aneurysm
- severe cranio-cerebral trauma within the last 3 months
- symptoms of subarachnoidal hemorrhage
- time of symptom onset unclear
- large surgical intervention or trauma within the last 10 days
- expected survival below 90 days after iv t-PA treatment
- severe hepatic disease, esophageal varices, acute pancreatitis
- septic embolism, endocarditis, pericarditis after myocardial infarction
- pregnancy or childbirth within the last 30 days or nursing mothers
- history of hemorrhagic diathesis or coagulopathy
- untreatable increase of arterial blood pressure (>185mmHg systolic, >110mmHg diastolic)
- intracranial hemorrhage, arteriovenous malformations or aneurysm at brain imaging
- thrombocytes <100'000 per microliter
- international normalized ratio (INR)>1.7 or partial thromboplastin time (PTT) prolongated
- serum glucose <2.7mmol/l or >22.2mmol/l
- severe renal insufficiency or other contraindications against CT-contrast agents
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
---|
Symptomatic intracranial hemorrhage (safety)
|
Functional outcome (efficacy)
|
Sekundære resultatmål
Resultatmål |
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Asymptomatic intracranial hemorrhage 24-48 hours after t-PA infusion
|
Early clinical recovery by 10 or more NIHSS points or dramatic recovery (total NIHSS 3 or less)at 24-48 hours after t-PA infusion
|
Mean mRS score at 90 days after t-PA infusion
|
Death occurring during study period
|
Recanalization at 24-48 hours after t-PA infusion
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Studiestol: Ralf W Baumgartner, MD, University Hospital of Zurich, Department of Neurology, Zurich, Switzerland
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juni 2006
Studieafslutning (Forventet)
1. juni 2009
Datoer for studieregistrering
Først indsendt
13. juni 2006
Først indsendt, der opfyldte QC-kriterier
13. juni 2006
Først opslået (Skøn)
14. juni 2006
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
27. april 2007
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
25. april 2007
Sidst verificeret
1. april 2007
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Iskæmi
- Patologiske processer
- Nekrose
- Hjerte-kar-sygdomme
- Karsygdomme
- Cerebrovaskulære lidelser
- Hjernesygdomme
- Sygdomme i centralnervesystemet
- Sygdomme i nervesystemet
- Embolisme og trombose
- Hjerneiskæmi
- Infarkt
- Slag
- Hjerneinfarkt
- Cerebrale arterielle sygdomme
- Intrakranielle arterielle sygdomme
- Intrakraniel emboli og trombose
- Tromboemboli
- Cerebralt infarkt
- Embolisme
- Trombose
- Infarkt, mellemhjernearterie
- Intrakraniel emboli
Andre undersøgelses-id-numre
- E-031/2004
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .