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Evaluate Effect of Optison on Pulmonary Artery Systolic Pressure (PASP) and Pulmonary Vascular Resistance (PVR).

NCT ID: NCT00878878

Last Updated: 2012-08-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2010-07-31

Brief Summary

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The design of this study is to conduct a comprehensive safety evaluation of the pulmonary hemodynamic effects of Optison. The study is being conducted in subjects referred for cardiac catheterization for clinical reasons.

Detailed Description

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Conditions

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Pulmonary Hypertension

Keywords

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Pulmonary artery systolic pressure (PASP) Pulmonary Vascular Resistance (PVR) Right Heart Catheterization Pulmonary hemodynamics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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Arm A

Group Type EXPERIMENTAL

Optison (Perflutren Protein-Type A Microspheres Injectable Suspension)

Intervention Type DRUG

Arm A: Single intravenous (IV) injection of 0.5 mL Optison followed by single IV injection of 0.5 mL 5% dextrose.

Arm B: Single IV injection of 0.5 mL 5% dextrose followed by single IV injection of 0.5 mL Optison.

Dextrose

Intervention Type DRUG

Arm A: Single intravenous (IV) injection of 0.5 mL Optison followed by single IV injection of 0.5 mL 5% dextrose.

Arm B: Single IV injection of 0.5 mL 5% dextrose followed by single IV injection of 0.5 mL Optison.

Arm B

Group Type EXPERIMENTAL

Optison (Perflutren Protein-Type A Microspheres Injectable Suspension)

Intervention Type DRUG

Arm A: Single intravenous (IV) injection of 0.5 mL Optison followed by single IV injection of 0.5 mL 5% dextrose.

Arm B: Single IV injection of 0.5 mL 5% dextrose followed by single IV injection of 0.5 mL Optison.

Dextrose

Intervention Type DRUG

Arm A: Single intravenous (IV) injection of 0.5 mL Optison followed by single IV injection of 0.5 mL 5% dextrose.

Arm B: Single IV injection of 0.5 mL 5% dextrose followed by single IV injection of 0.5 mL Optison.

Interventions

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Optison (Perflutren Protein-Type A Microspheres Injectable Suspension)

Arm A: Single intravenous (IV) injection of 0.5 mL Optison followed by single IV injection of 0.5 mL 5% dextrose.

Arm B: Single IV injection of 0.5 mL 5% dextrose followed by single IV injection of 0.5 mL Optison.

Intervention Type DRUG

Dextrose

Arm A: Single intravenous (IV) injection of 0.5 mL Optison followed by single IV injection of 0.5 mL 5% dextrose.

Arm B: Single IV injection of 0.5 mL 5% dextrose followed by single IV injection of 0.5 mL Optison.

Intervention Type DRUG

Other Intervention Names

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Perflutren Protein-Type A Microspheres Injectable Suspension

Eligibility Criteria

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Inclusion Criteria

* Must be already scheduled for left and/or right heart catheterization for clinical reasons.
* Must be in sinus rhythm, without an arrhythmia likely to affect the ability to assess pulmonary hemodynamics by catheterization, as determined by the investigator.
* Women of childbearing potential must be using adequate birth control and have a negative pregnancy test.

Exclusion Criteria

* History of right-to-left, bi-directional, or transient right-to-left cardiac shunts or diagnosed by color flow Doppler echocardiography during screening.
* Hypersensitivity to Optison, perflutren, blood, blood products, or albumin.
* Female subjects who are nursing mothers.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ICON Clinical Research

INDUSTRY

Sponsor Role collaborator

GE Healthcare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christopher Jefferds

Role: STUDY_DIRECTOR

ICON Development Solutions

Locations

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ICON Development Solutions

Elliott, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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GE-191-004

Identifier Type: -

Identifier Source: org_study_id