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

Pulmonary Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00878878
• Other study ID #: GE-191-004
• Status: Completed
• Phase: Phase 4
• First received: April 8, 2009
• Last updated: July 19, 2012
• Start date: March 2009
• Est. completion date: July 2010

Study information

• Verified date: July 2012
• Source: GE Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	ICON Development Solutions	Elliott City	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
GE Healthcare	ICON Clinical Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Measurements recorded at Baseline, 2 minutes, 6 minutes and 10 minutes post contrast administration	Yes
Primary	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.	Measurements recorded at Baseline, 2 minutes, 6 minutes and 10 minutes post contrast administration	Yes
Secondary	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.	During the injection and catheterization procedure, and for up to 24 hours post-injection	Yes