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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00878878
First Posted: April 9, 2009
Last Update Posted: August 24, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
ICON Clinical Research
Information provided by (Responsible Party):
GE Healthcare
  Purpose
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.

Condition Intervention Phase
Pulmonary Hypertension Drug: Optison (Perflutren Protein-Type A Microspheres Injectable Suspension) Drug: Dextrose Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official 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

Resource links provided by NLM:


Further study details as provided by GE Healthcare:

Primary Outcome Measures:
  • 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.

  • 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 Outcome Measures:
  • 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.



Enrollment: 30
Study Start Date: March 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A Drug: 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.

Other Name: Perflutren Protein-Type A Microspheres Injectable Suspension
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.

Experimental: Arm B Drug: 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.

Other Name: Perflutren Protein-Type A Microspheres Injectable Suspension
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.


  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00878878


Locations
United States, Maryland
ICON Development Solutions
Elliott City, Maryland, United States, 21043
Sponsors and Collaborators
GE Healthcare
ICON Clinical Research
Investigators
Study Director: Christopher Jefferds ICON Development Solutions
  More Information

Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT00878878     History of Changes
Other Study ID Numbers: GE-191-004
First Submitted: April 8, 2009
First Posted: April 9, 2009
Results First Submitted: April 4, 2012
Results First Posted: August 24, 2012
Last Update Posted: August 24, 2012
Last Verified: July 2012

Keywords provided by GE Healthcare:
Pulmonary artery systolic pressure (PASP)
Pulmonary Vascular Resistance (PVR)
Right Heart Catheterization
Pulmonary hemodynamics

Additional relevant MeSH terms:
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases