Microbubbles and Ultrasound in Stroke Trial: MUST Study

NCT ID: NCT00222040

Last Updated: 2010-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2004-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Ischemic Stroke

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Stroke thrombolysis ultrasound microbubbles alteplase

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Levovist

Group Type EXPERIMENTAL

Ultrasound

Intervention Type RADIATION

2-MHz, low intensity transcranial ultrasound

Levovist

Intervention Type DRUG

D-Galactose and palmitic palmitique intravenous 4 g

2

No specific intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ultrasound

2-MHz, low intensity transcranial ultrasound

Intervention Type RADIATION

Levovist

D-Galactose and palmitic palmitique intravenous 4 g

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Acute ischemic stroke
* MCA proximal occlusion on CT or MR angiography
* Thrombolysis with intravenous alteplase initiated within 3 hours of stroke onset
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ministry of Health, France

OTHER_GOV

Sponsor Role collaborator

University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

University Hospital Toulouse

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

LARRUE Vincent, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse, France

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Service de Neurologie

Besançon, , France

Site Status

Service de Neurologie, Hôpital Gui de Chauliac

Montpellier, , France

Site Status

Service de Neurologie, Hôpital Sainte Anne

Paris, , France

Site Status

Service de Neurologie Vasculaire, University Hospital

Toulouse, , France

Site Status

Service de Neurologie, University Hospital

Tours, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

Cintas P, Le Traon AP, Larrue V. High rate of recanalization of middle cerebral artery occlusion during 2-MHz transcranial color-coded Doppler continuous monitoring without thrombolytic drug. Stroke. 2002 Feb;33(2):626-8. doi: 10.1161/hs0202.103073.

Reference Type BACKGROUND
PMID: 11823681 (View on PubMed)

Cintas P, Nguyen F, Boneu B, Larrue V. Enhancement of enzymatic fibrinolysis with 2-MHz ultrasound and microbubbles. J Thromb Haemost. 2004 Jul;2(7):1163-6. doi: 10.1111/j.1538-7836.2004.00746.x.

Reference Type BACKGROUND
PMID: 15219200 (View on PubMed)

Viguier A, Petit R, Rigal M, Cintas P, Larrue V. Continuous monitoring of middle cerebral artery recanalization with transcranial color-coded sonography and Levovist. J Thromb Thrombolysis. 2005 Feb;19(1):55-9. doi: 10.1007/s11239-005-0940-6.

Reference Type BACKGROUND
PMID: 15976968 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

0302208

Identifier Type: -

Identifier Source: org_study_id