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Ultrasound Enhanced Thrombolytic Therapy of Middle Cerebral Artery Occlusion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00336596
Recruitment Status : Unknown
Verified April 2007 by University of Zurich.
Recruitment status was:  Recruiting
First Posted : June 14, 2006
Last Update Posted : April 27, 2007
Swiss National Science Foundation
Information provided by:
University of Zurich

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Intracranial Embolism Thrombosis Procedure: transcranial ultrasound in patients treated with iv t-PA Phase 3

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transcranial Ultrasound Enhanced Thrombolysis (TRUST)
Study Start Date : June 2006
Estimated Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Primary Outcome Measures :
  1. Symptomatic intracranial hemorrhage (safety)
  2. Functional outcome (efficacy)

Secondary Outcome Measures :
  1. Asymptomatic intracranial hemorrhage 24-48 hours after t-PA infusion
  2. 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
  3. Mean mRS score at 90 days after t-PA infusion
  4. Death occurring during study period
  5. Recanalization at 24-48 hours after t-PA infusion

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00336596

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Contact: Ralf W Baumgartner, MD +41 1 255 56 86

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Kantonsspital Aarau, Department of Neurology Recruiting
Aarau, Switzerland
Contact: Hansjörg Hungerbühler, MD    +41 62 838 66 75   
Principal Investigator: Hansjörg Hungerbühler, MD         
University Hospital of Basel, Department of Neurology Recruiting
Basel, Switzerland
Contact: Stefan Engelter, MD    +41 61 265 25 25   
Principal Investigator: Philippe Lyrer, MD         
Principal Investigator: Stefan Engelter, MD         
University hospital of Bern, Department of Neurology Recruiting
Bern, Switzerland
Contact: Marcel Arnold, MD    +41 31 632 33 32   
Principal Investigator: H.-P. Mattle, MD         
Principal Investigator: Marcel Arnold, MD         
University Hospital of Geneva, Department of Neurology Recruiting
Geneva, Switzerland
Contact: Roman Sztajzel, MD    +41 22 372 83 10   
Principal Investigator: Roman Sztajzel, MD         
University Hospital of Lausanne, Department of Neurology Recruiting
Lausanne, Switzerland
Contact: Patrik Michel, MD    +41 21 314 11 85   
Principal Investigator: Patrik Michel, MD         
University Hospital of Zurich, Department of Neurology Recruiting
Zurich, Switzerland, 8091
Contact: Ralf W Baumgartner, MD    +41 1 255 56 86   
Contact: Dimitrios Georgiadis, MD   
Principal Investigator: Ralf W Baumgartner, MD         
Principal Investigator: Dimitrios Georgiadis, MD         
Sub-Investigator: Hakan Sarikaya, MD         
Sponsors and Collaborators
University of Zurich
Swiss National Science Foundation
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Study Chair: Ralf W Baumgartner, MD University Hospital of Zurich, Department of Neurology, Zurich, Switzerland

Layout table for additonal information Identifier: NCT00336596     History of Changes
Other Study ID Numbers: E-031/2004
First Posted: June 14, 2006    Key Record Dates
Last Update Posted: April 27, 2007
Last Verified: April 2007

Keywords provided by University of Zurich:
middle cerebral artery occlusion
intracranial embolism and thrombosis
ultrasound enhanced thrombolysis
Patients receiving iv thrombolytic therapy (t-PA)

Additional relevant MeSH terms:
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Intracranial Embolism
Infarction, Middle Cerebral Artery
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Intracranial Embolism and Thrombosis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Cerebral Infarction
Brain Infarction
Brain Ischemia
Cerebral Arterial Diseases
Intracranial Arterial Diseases
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action