Microbubbles and Ultrasound in Stroke Trial: MUST Study

This study has been terminated.
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by:
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT00222040
First received: September 15, 2005
Last updated: April 29, 2010
Last verified: June 2008
  Purpose

To determine whether transcranial 2-MHz ultrasound combined with intravenous administration of microbubbles improves early recanalization in patients with acute ischemic stroke caused by middle cerebral artery (MCA) proximal occlusion treated with intravenous alteplase within 3 hours of symptom onset.


Condition Intervention Phase
Acute Ischemic Stroke
Radiation: Ultrasound
Drug: Levovist
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:
  • Rate of early recanalization on post-treatment MR or CT angiography. Recanalization is described using the tIMI classification. [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Rate of symptomatic intracerebral hemorrhage, mortality, Score on the modified Rankin scale [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: June 2004
Study Completion Date: June 2004
Primary Completion Date: June 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Levovist
Radiation: Ultrasound
2-MHz, low intensity transcranial ultrasound
Drug: Levovist
D-Galactose and palmitic palmitique intravenous 4 g
Other Name: Levovist
No Intervention: 2
No specific intervention

Detailed Description:

Proximal MCA occlusion is recognized using MR or CT angiography performed before inclusion. All patients are treated with alteplase according to current guidelines. In addition, patients randomized in the active group are continuously exposed to transcranial 2-MHz ultrasound for 1 hour combined with intravenous administration of microbubbles. Controls are only treated with alteplase. The ultrasound beam is positioned at the thrombus/blood flow interface using color-coded sonography. Galactose-based microbubbles are administered via continuous intravenous infusion over 40 min.

Early recanalization is assessed using MR or CT angiography 4 to 8 hours after symptom onset. The evaluation of angiograms is performed by 2 neuroradiologists blinded to group of randomization and clinical details. The primary outcome measure is the rate of early recanalization. Recanalization is assessed using the TIMI classification. Secondary endpoints include the rate of symptomatic intracerebral hemorrhage, mortality, and functional outcome on the modified Rankin scale at 3 months.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Acute ischemic stroke
  • MCA proximal occlusion on CT or MR angiography
  • Thrombolysis with intravenous alteplase initiated within 3 hours of stroke onset
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00222040

Locations
France
Service de Neurologie
Besancon, France, 25030
Service de Neurologie, Hôpital Gui de Chauliac
Montpellier, France, 34295
Service de Neurologie, Hôpital Sainte Anne
Paris, France, 75674
Service de Neurologie Vasculaire, University Hospital
Toulouse, France, 31059
Service de Neurologie, University Hospital
Tours, France, 37044
Sponsors and Collaborators
University Hospital, Toulouse
Ministry of Health, France
Investigators
Principal Investigator: LARRUE Vincent, MD University Hospital Toulouse, FRANCE
  More Information

Additional Information:
Publications:
Responsible Party: LLAU Marie-Elise, University Hospital Toulouse
ClinicalTrials.gov Identifier: NCT00222040     History of Changes
Other Study ID Numbers: 0302208
Study First Received: September 15, 2005
Last Updated: April 29, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Toulouse:
Stroke
thrombolysis
ultrasound
microbubbles
alteplase

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
SHU 508
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014