Microbubble-Enhanced Clotbust Treatment of Acute Ischemic Stroke

July 25, 2007 updated by: ImaRx Therapeutics
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of symptomatic intracranial hemorrhage
Time Frame: 72 hours
72 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Complete recanalization of the occluded artery (TIBI 4-5)
Time Frame: End of treatment
End of treatment
NIHSS score of 0-2
Time Frame: 24 hours
24 hours
Favorable outcome (modified Rankin Scale or NIHSS 0-1)
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ImaRx Therapeutics

Investigators

  • Principal Investigator: Andrei Alexandrov, MD, The University of Texas Health Science Center, Houston

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Study Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

July 25, 2007

First Submitted That Met QC Criteria

July 25, 2007

First Posted (Estimate)

July 27, 2007

Study Record Updates

Last Update Posted (Estimate)

July 27, 2007

Last Update Submitted That Met QC Criteria

July 25, 2007

Last Verified

July 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRX-815-401

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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