NCT00222040

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2004

Geographic Reach
1 country

5 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 15, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
Last Updated

April 30, 2010

Status Verified

June 1, 2008

Enrollment Period

Same day

First QC Date

September 15, 2005

Last Update Submit

April 29, 2010

Conditions

Acute Ischemic Stroke

Keywords

Strokethrombolysisultrasoundmicrobubblesalteplase

Outcome Measures

Primary Outcomes (1)

  • Rate of early recanalization on post-treatment MR or CT angiography. Recanalization is described using the tIMI classification.

Secondary Outcomes (1)

  • Rate of symptomatic intracerebral hemorrhage, mortality, Score on the modified Rankin scale

    3 months

Study Arms (2)

1

EXPERIMENTAL

Levovist

Radiation: UltrasoundDrug: Levovist

2

NO INTERVENTION

No specific intervention

Interventions

UltrasoundRADIATION

2-MHz, low intensity transcranial ultrasound

1
LevovistDRUG

D-Galactose and palmitic palmitique intravenous 4 g

1

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Service de Neurologie

Besançon, 25030, France

Location

Service de Neurologie, Hôpital Gui de Chauliac

Montpellier, 34295, France

Location

Service de Neurologie, Hôpital Sainte Anne

Paris, 75674, France

Location

Service de Neurologie Vasculaire, University Hospital

Toulouse, 31059, France

Location

Service de Neurologie, University Hospital

Tours, 37044, France

Location

Related Publications (3)

  • 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.

    PMID: 11823681BACKGROUND

  • 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.

    PMID: 15219200BACKGROUND

  • 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.

    PMID: 15976968BACKGROUND

MeSH Terms

Conditions

Ischemic StrokeStroke

Interventions

High-Energy Shock WavesSHU 508

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • LARRUE Vincent, MD

    University Hospital, Toulouse, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 15, 2005

First Posted

September 22, 2005

Study Start

June 1, 2004

Primary Completion

June 1, 2004

Study Completion

June 1, 2004

Last Updated

April 30, 2010

Record last verified: 2008-06

Locations

FR(5)