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OpenTrials
Completed

NCT Number: NCT00878878

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

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.

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Key information

Conditions

Pulmonary Hypertension Cardiovascular Diseases Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

ICON Development Solutions

Elliott, Maryland, 21043, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Optison (Perflutren Protein-Type A Microspheres Injectable Suspension)

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.

Other names: Perflutren Protein-Type A Microspheres Injectable Suspension

Dextrose

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.

Primary outcomes

  1. Observed the Change of Pulmonary Artery Systolic Pressure (PASP) Measured by Millimeters of Mercury (mm hg) Within Certain Time Periods. This is Per Sequence and Not a Cross-over Study.

    Time frame: Measurements recorded at Baseline, 2 minutes, 6 minutes and 10 minutes post contrast administration

    Measurement of the Pulmonary artery systolic pressure (PASP) results, which were taken from the subject in millimeters of mercury; a unit of pressure (mm hg), at Baseline and at 2 minutes, 6 minutes and 10 minutes. This is per sequence and not a cross-over study.

  2. Observed the Change of Pulmonary Vascular Resistance (PVR) Measured by Wood Units Within Certain Time Periods. This is Per Sequence and Not a Cross-over Study.

    Time frame: Measurements recorded at Baseline, 2 minutes, 6 minutes and 10 minutes post contrast administration

    Measurement of the pulmonary vascular resistance (PVR) results, which was taken from the subject in Wood Units, taken at Baseline and at 2 minutes, 6 minutes and 10 minutes. This is per sequence and not a cross-over study.

Secondary outcomes

  1. Recorded Any Adverse Events From the Optison and Control Solution (5% Dextrose) Used in Subjects With Normal and Elevated Pulmonary Artery Systolic Pressure (PASP. This is Per Sequence and Not a Cross-over Study.

    Time frame: During the injection and catheterization procedure, and for up to 24 hours post-injection

    Observe subjects with normal pulmonary artery systolic pressure (PASP) and elevated pulmonary artery systolic pressure (PASP) as measured by any adverse events.

    The number of participants were stratified based on a screening pulmonary artery systolic pressure (PASP). Subjects stratified by; 11 subjects that were Normal PASP and 19 subjects that were Elevated PASP.

    This is per sequence and not a cross-over study.

Sponsors and collaborators

Lead sponsor

GE Healthcare

Industry

Collaborators

  • ICON Clinical Research

Registry information

Official study title

A Phase 4, Placebo Controlled, Single-blind, Cross-over Safety Study to Evaluate the Effect of Optison on Pulmonary Artery Systolic Pressure (PASP) and Pulmonary Vascular Resistance (PVR) as Measured by Right Heart Catheterization

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Apr 9, 2009
Registry last updated
Aug 24, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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