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

Primary Purpose

Pulmonary Hypertension

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Optison (Perflutren Protein-Type A Microspheres Injectable Suspension)
Dextrose
Sponsored by
GE Healthcare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pulmonary Hypertension focused on measuring Pulmonary artery systolic pressure (PASP), Pulmonary Vascular Resistance (PVR), Right Heart Catheterization, Pulmonary hemodynamics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • ICON Development Solutions

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm A

Arm B

Arm Description

Outcomes

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.
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.
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.
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.

Full Information

First Posted
April 8, 2009
Last Updated
July 19, 2012
Sponsor
GE Healthcare
Collaborators
ICON Clinical Research
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1. Study Identification

Unique Protocol Identification Number
NCT00878878
Brief Title
Evaluate Effect of Optison on Pulmonary Artery Systolic Pressure (PASP) and Pulmonary Vascular Resistance (PVR).
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GE Healthcare
Collaborators
ICON Clinical Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension
Keywords
Pulmonary artery systolic pressure (PASP), Pulmonary Vascular Resistance (PVR), Right Heart Catheterization, Pulmonary hemodynamics

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Experimental
Arm Title
Arm B
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Optison (Perflutren Protein-Type A Microspheres Injectable Suspension)
Other Intervention Name(s)
Perflutren Protein-Type A Microspheres Injectable Suspension
Intervention Description
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
Intervention Name(s)
Dextrose
Intervention Description
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 Outcome Measure Information:
Title
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.
Description
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.
Time Frame
Measurements recorded at Baseline, 2 minutes, 6 minutes and 10 minutes post contrast administration
Title
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.
Description
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.
Time Frame
Measurements recorded at Baseline, 2 minutes, 6 minutes and 10 minutes post contrast administration
Secondary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
During the injection and catheterization procedure, and for up to 24 hours post-injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Jefferds
Organizational Affiliation
ICON Development Solutions
Official's Role
Study Director
Facility Information:
Facility Name
ICON Development Solutions
City
Elliott City
State/Province
Maryland
ZIP/Postal Code
21043
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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