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

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 Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject) 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:

MedlinePlus related topics: High Blood Pressure Pulmonary Hypertension

Drug Information available for: Perflutren Dextrose

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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.

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party:	GE Healthcare
ClinicalTrials.gov Identifier:	NCT00878878 History of Changes
Other Study ID Numbers:	GE-191-004
Study First Received:	April 8, 2009
Results First Received:	April 4, 2012
Last Updated:	July 19, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by GE Healthcare:

Pulmonary artery systolic pressure (PASP)
Pulmonary Vascular Resistance (PVR)
Right Heart Catheterization
Pulmonary hemodynamics

Additional relevant MeSH terms:

Hypertension
Hypertension, Pulmonary
Vascular Diseases

Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 19, 2013