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

NCT ID: NCT00878878

Last Updated: 2012-08-24

Basic Information

• 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

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.

Conditions

Pulmonary Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

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

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

Perflutren Protein-Type A Microspheres Injectable Suspension

Eligibility Criteria

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

ICON Clinical Research

INDUSTRY

Sponsor Role: collaborator

GE Healthcare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher Jefferds

Role: STUDY_DIRECTOR

ICON Development Solutions

Locations

ICON Development Solutions

Elliott, Maryland, United States

Countries

United States

Other Identifiers

GE-191-004

Identifier Type: -

Identifier Source: org_study_id