Ultrasound Enhanced Thrombolytic Therapy of Middle Cerebral Artery Occlusion

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by University of Zurich.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Swiss National Science Foundation
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT00336596
First received: June 13, 2006
Last updated: April 25, 2007
Last verified: April 2007
  Purpose

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 Intervention Phase
Intracranial Embolism
Thrombosis
Procedure: transcranial ultrasound in patients treated with iv t-PA
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Transcranial Ultrasound Enhanced Thrombolysis (TRUST)

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Symptomatic intracranial hemorrhage (safety)
  • Functional outcome (efficacy)

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 400
Study Start Date: June 2006
Estimated Study Completion Date: June 2009
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00336596

Contacts
Contact: Ralf W Baumgartner, MD +41 1 255 56 86 ralf.baumgartner@usz.ch

Locations
Switzerland
Kantonsspital Aarau, Department of Neurology Recruiting
Aarau, Switzerland
Contact: Hansjörg Hungerbühler, MD    +41 62 838 66 75    hansjoerg.hungerbuehler@ksa.ch   
Principal Investigator: Hansjörg Hungerbühler, MD         
University Hospital of Basel, Department of Neurology Recruiting
Basel, Switzerland
Contact: Stefan Engelter, MD    +41 61 265 25 25    sengelter@uhbs.ch   
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    marcel.arnold@insel.ch   
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    Roman.Sztajzel@hcuge.ch   
Principal Investigator: Roman Sztajzel, MD         
University Hospital of Lausanne, Department of Neurology Recruiting
Lausanne, Switzerland
Contact: Patrik Michel, MD    +41 21 314 11 85    patrik.michel@chuv.hospvd.ch   
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    ralf.baumgartner@usz.ch   
Contact: Dimitrios Georgiadis, MD       dimitrios.georgiadis@usz.ch   
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
Investigators
Study Chair: Ralf W Baumgartner, MD University Hospital of Zurich, Department of Neurology, Zurich, Switzerland
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00336596     History of Changes
Other Study ID Numbers: E-031/2004
Study First Received: June 13, 2006
Last Updated: April 25, 2007
Health Authority: Switzerland: Swissmedic

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

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

ClinicalTrials.gov processed this record on April 17, 2014