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Ultrasound Enhanced Thrombolytic Therapy of Middle Cerebral Artery Occlusion

Primary Purpose

Intracranial Embolism, Thrombosis

Status
Unknown status
Phase
Phase 3
Locations
Switzerland
Study Type
Interventional
Intervention
transcranial ultrasound in patients treated with iv t-PA
Sponsored by
University of Zurich
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intracranial Embolism focused on measuring middle cerebral artery occlusion, intracranial embolism and thrombosis, ultrasound enhanced thrombolysis, Patients receiving iv thrombolytic therapy (t-PA)

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kantonsspital Aarau, Department of NeurologyRecruiting
  • University Hospital of Basel, Department of NeurologyRecruiting
  • University hospital of Bern, Department of NeurologyRecruiting
  • University Hospital of Geneva, Department of NeurologyRecruiting
  • University Hospital of Lausanne, Department of NeurologyRecruiting
  • University Hospital of Zurich, Department of NeurologyRecruiting

Outcomes

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

Full Information

First Posted
June 13, 2006
Last Updated
April 25, 2007
Sponsor
University of Zurich
Collaborators
Swiss National Science Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00336596
Brief Title
Ultrasound Enhanced Thrombolytic Therapy of Middle Cerebral Artery Occlusion
Official Title
Transcranial Ultrasound Enhanced Thrombolysis (TRUST)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Unknown status
Study Start Date
June 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Zurich
Collaborators
Swiss National Science Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Embolism, Thrombosis
Keywords
middle cerebral artery occlusion, intracranial embolism and thrombosis, ultrasound enhanced thrombolysis, Patients receiving iv thrombolytic therapy (t-PA)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
transcranial ultrasound in patients treated with iv t-PA
Primary Outcome Measure Information:
Title
Symptomatic intracranial hemorrhage (safety)
Title
Functional outcome (efficacy)
Secondary Outcome Measure Information:
Title
Asymptomatic intracranial hemorrhage 24-48 hours after t-PA infusion
Title
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
Title
Mean mRS score at 90 days after t-PA infusion
Title
Death occurring during study period
Title
Recanalization at 24-48 hours after t-PA infusion

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ralf W Baumgartner, MD
Phone
+41 1 255 56 86
Email
ralf.baumgartner@usz.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ralf W Baumgartner, MD
Organizational Affiliation
University Hospital of Zurich, Department of Neurology, Zurich, Switzerland
Official's Role
Study Chair
Facility Information:
Facility Name
Kantonsspital Aarau, Department of Neurology
City
Aarau
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hansjörg Hungerbühler, MD
Phone
+41 62 838 66 75
Email
hansjoerg.hungerbuehler@ksa.ch
First Name & Middle Initial & Last Name & Degree
Hansjörg Hungerbühler, MD
Facility Name
University Hospital of Basel, Department of Neurology
City
Basel
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefan Engelter, MD
Phone
+41 61 265 25 25
Email
sengelter@uhbs.ch
First Name & Middle Initial & Last Name & Degree
Philippe Lyrer, MD
First Name & Middle Initial & Last Name & Degree
Stefan Engelter, MD
Facility Name
University hospital of Bern, Department of Neurology
City
Bern
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcel Arnold, MD
Phone
+41 31 632 33 32
Email
marcel.arnold@insel.ch
First Name & Middle Initial & Last Name & Degree
H.-P. Mattle, MD
First Name & Middle Initial & Last Name & Degree
Marcel Arnold, MD
Facility Name
University Hospital of Geneva, Department of Neurology
City
Geneva
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roman Sztajzel, MD
Phone
+41 22 372 83 10
Email
Roman.Sztajzel@hcuge.ch
First Name & Middle Initial & Last Name & Degree
Roman Sztajzel, MD
Facility Name
University Hospital of Lausanne, Department of Neurology
City
Lausanne
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrik Michel, MD
Phone
+41 21 314 11 85
Email
patrik.michel@chuv.hospvd.ch
First Name & Middle Initial & Last Name & Degree
Patrik Michel, MD
Facility Name
University Hospital of Zurich, Department of Neurology
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ralf W Baumgartner, MD
Phone
+41 1 255 56 86
Email
ralf.baumgartner@usz.ch
First Name & Middle Initial & Last Name & Degree
Dimitrios Georgiadis, MD
Email
dimitrios.georgiadis@usz.ch
First Name & Middle Initial & Last Name & Degree
Ralf W Baumgartner, MD
First Name & Middle Initial & Last Name & Degree
Dimitrios Georgiadis, MD
First Name & Middle Initial & Last Name & Degree
Hakan Sarikaya, MD

12. IPD Sharing Statement

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Ultrasound Enhanced Thrombolytic Therapy of Middle Cerebral Artery Occlusion

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