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

• ClinicalTrials.gov Identifier: NCT00878878
• Recruitment Status: Completed
• First Posted: April 9, 2009
• Results First Posted: August 24, 2012
• Last Update Posted: August 24, 2012
• Sponsor: GE Healthcare
• Collaborator: ICON Clinical Research
• Information provided by (Responsible Party): GE Healthcare

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.

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 30 participants
• 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
• Study Start Date: March 2009
• Actual Primary Completion Date: July 2010
• Actual Study Completion Date: July 2010

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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

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
• Other Study ID Numbers: GE-191-004
• First Posted: April 9, 2009
• 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; Systolic Murmurs; Hypertension; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Heart Murmurs