Microbubble-Enhanced Clotbust Treatment of Acute Ischemic Stroke

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

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2006-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Ischemic Stroke

Keywords

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Acute Ischemic Stroke Microbubbles Transcranial Doppler ultrasound TIBI Symptomatic Intracranial Hemorrhage modified Rankin Scale Recanalization Perflutren

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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perflutren lipid microsphere

Intervention Type DRUG

Other Intervention Names

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Definity

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Andrei Alexandrov, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

References

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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.

Reference Type BACKGROUND

PMID: 15548777 (View on PubMed)

Other Identifiers

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MRX-815-401

Identifier Type: -

Identifier Source: org_study_id