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

• Sponsor: GE Healthcare (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00878878
• Collaborator: ICON Clinical Research (Industry)
• Enrollment: 30
• Location: 1
• Arms: 2
• Duration (Months): 16
• Patients Per Site Per Month: 1.9

Study Details

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
• 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: Mar 1, 2009
• Actual Primary Completion Date: Jul 1, 2010
• Actual Study Completion Date: Jul 1, 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 Names: 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 Names: 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. [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. [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. [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

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: GE Healthcare
• ClinicalTrials.gov Identifier: NCT00878878
• Other Study ID Numbers: GE-191-004
• First Posted: Apr 9, 2009
• Last Update Posted: Aug 24, 2012
• Last Verified: Jul 1, 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

Study Results

Participant Flow

Arm/Group Title	Optison First, Then Followed by Placebo Control	Placebo Control First, Then Followed by Optison Product
Arm/Group Description	Optison product (Perflutren Protein-Type A Microspheres Injectable Suspension, USP) given first, than the Placebo Control (5% Dextrose). There was a 15 minute interval between the injections.	Placebo Control (5% Dextrose) was used first, then the Optison product (Perflutren Protein-Type A Microspheres Injectable Suspension, USP). There was a 15 minute interval between the injections.
Period Title: Overall Study
STARTED	15	15
COMPLETED	15	15
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Optison First, Then Followed by Placebo Control	Placebo Control First, Then Followed by Optison Product	Total
Arm/Group Description	Optison product (Perflutren Protein-Type A Microspheres Injectable Suspension, USP) given first, than the Placebo Control (5% Dextrose). There was a 15 minute interval between the injections.	Placebo Control (5% Dextrose) was used first, then the Optison product (Perflutren Protein-Type A Microspheres Injectable Suspension, USP). There was a 15 minute interval between the injections.	Total of all reporting groups
Overall Participants	15	15	30
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	9 60%	8 53.3%	17 56.7%
>=65 years	6 40%	7 46.7%	13 43.3%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	53 (16.1)	60 (16.7)	57 (16.5)
Sex: Female, Male (Count of Participants)
Female	7 46.7%	9 60%	16 53.3%
Male	8 53.3%	6 40%	14 46.7%
Region of Enrollment (participants) [Number]
United States	15 100%	15 100%	30 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

The Pulmonary artery systolic pressure (PASP) results were taken at Baseline and at 2 minutes, 6 minutes and 10 minutes.

Arm/Group Title	Optison Given First, Then Placebo Control (5%Dextrose)	Placebo Control (5% Dextrose) Given First, Then Optison
Arm/Group Description	Optison product (Perflutren Protein-Type A Microspheres Injectable Suspension, USP) was given first followed by the Placebo Control (5% Dextrose). There was a 15 minute interval between the injections.	Placebo Control (5% Dextrose) was given first followed by the Optison product (Perflutren Protein-Type A Microspheres Injectable Suspension, USP). There was a 15 minute interval between the injections.
Measure Participants	15	15
PASP (Units: mmHg) - Baseline	55.2 (28.1)	53.7 (27.1)
2 min Post	55.6 (27.9)	53.8 (26.9)
6 min Post	54.1 (28.1)	54.6 (27.7)
10 min Post	54.57 (27.0)	54.9 (27.6)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

The number of participants were stratified based on a screening pulmonary artery systolic pressure (PASP). Subjects stratified by; Normal PASP and Elevated PASP.

Arm/Group Title	Normal Pulmonary Artery Systolic Pressure (PASP)	Elevated Pulmonary Artery Systolic Pressure (PASP)
Arm/Group Description	Observe subjects with normal 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).	Observe subjects with 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).
Measure Participants	11	19
Subjects with Serious adverse event up to 24h post	0	0
Subjects with adverse event-up to 24h post	0	1

3. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

The pulmonary vascular resistance (PVR) results were taken at Baseline and at 2 minutes, 6 minutes and 10 minutes.

Arm/Group Title	Optison Given First, Then Placebo Control (5%Dextrose)	Placebo Control (5% Dextrose) Given First, Then Optison
Arm/Group Description	Optison product (Perflutren Protein-Type A Microspheres Injectable Suspension, USP) was given first followed by the Placebo Control (5% Dextrose). There was a 15 minute interval between the injections.	Placebo Control (5% Dextrose) was given first followed by the Optison product (Perflutren Protein-Type A Microspheres Injectable Suspension, USP). There was a 15 minute interval between the injections.
Measure Participants	15	15
PVR (Units: Wood Units) - Baseline	3.6 (2.9)	3.9 (4.0)
2 min Post	3.67 (3.56)	3.9 (4.4)
6 min Post	3.3 (2.9)	3.87 (3.68)
10 min Post	3.8 (3.4)	3.5 (3.3)

Adverse Events

Arm/Group Title	Optison Product First Followed by Placebo Control (5%Dextrose)		Placebo Control (5% Dextrose) First Followed by the Optison
Arm/Group Description	Optison product (Perflutren Protein-Type A Microspheres Injectable Suspension, USP) given first followed by the Placebo Control (5% Dextrose). There was a 15 minute interval between the injections.		Placebo Control (5% Dextrose) given first followed by the Optison product (Perflutren Protein-Type A Microspheres Injectable Suspension, USP. There was a 15 minute interval between the injections.
All Cause Mortality
	Optison Product First Followed by Placebo Control (5%Dextrose)		Placebo Control (5% Dextrose) First Followed by the Optison
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Optison Product First Followed by Placebo Control (5%Dextrose)		Placebo Control (5% Dextrose) First Followed by the Optison
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/15 (0%)
Other (Not Including Serious) Adverse Events
	Optison Product First Followed by Placebo Control (5%Dextrose)		Placebo Control (5% Dextrose) First Followed by the Optison
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		1/15 (6.7%)
Injury, poisoning and procedural complications
Procedural Pain	0/15 (0%)	0	1/15 (6.7%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.