NCT00507806

Brief Summary

The study is designed to examine the safety, tolerability, and activity of a combination of microbubbles (perflutren lipid microsphere \[Definity®\]) and continuous monitoring with 2 MHz transcranial Doppler ultrasound (TCD) as an adjunctive therapy to tissue plasminogen activator (tPA) treatment in subjects with acute ischemic stroke.

Trial Health

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Trial Health Score

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

Timeline
Completed

Started Mar 2005

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 25, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 27, 2007

Completed
Last Updated

July 27, 2007

Status Verified

July 1, 2007

First QC Date

July 25, 2007

Last Update Submit

July 25, 2007

Conditions

Acute Ischemic Stroke

Keywords

Acute Ischemic StrokeMicrobubblesTranscranial Doppler ultrasoundTIBISymptomatic Intracranial Hemorrhagemodified Rankin ScaleRecanalizationPerflutren

Outcome Measures

Primary Outcomes (1)

  • Incidence of symptomatic intracranial hemorrhage

    72 hours

Secondary Outcomes (3)

  • Complete recanalization of the occluded artery (TIBI 4-5)

    End of treatment

  • NIHSS score of 0-2

    24 hours

  • Favorable outcome (modified Rankin Scale or NIHSS 0-1)

    3 months

Interventions

perflutren lipid microsphereDRUG
Also known as: Definity

Eligibility Criteria

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

You may qualify if:

  • Measurable focal neurological deficit (National Institutes of Health Stroke Scale \[NIHSS\] score \> 4 points)
  • tPA eligible
  • Occlusion of the middle cerebral artery

You may not qualify if:

  • Right to left cardiac shunt
  • Uncontrolled hypertension
  • Absent temporal windows

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Alexandrov AV, Molina CA, Grotta JC, Garami Z, Ford SR, Alvarez-Sabin J, Montaner J, Saqqur M, Demchuk AM, Moye LA, Hill MD, Wojner AW; CLOTBUST Investigators. Ultrasound-enhanced systemic thrombolysis for acute ischemic stroke. N Engl J Med. 2004 Nov 18;351(21):2170-8. doi: 10.1056/NEJMoa041175.

    PMID: 15548777BACKGROUND

MeSH Terms

Conditions

Ischemic Stroke

Interventions

perflutren

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Andrei Alexandrov, MD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 25, 2007

First Posted

July 27, 2007

Study Start

March 1, 2005

Study Completion

May 1, 2006

Last Updated

July 27, 2007

Record last verified: 2007-07