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

NCT00878878 | Completed Phase 4 Results DMC

• 1 other identifier: GE-191-004
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Hypertension

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (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

Study Arms (2)

Arm A

EXPERIMENTAL

Drug: Optison (Perflutren Protein-Type A Microspheres Injectable Suspension); Drug: Dextrose

Arm B

EXPERIMENTAL

Drug: Optison (Perflutren Protein-Type A Microspheres Injectable Suspension); Drug: Dextrose

Interventions

Optison (Perflutren Protein-Type A Microspheres Injectable Suspension) DRUG

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.

Also known as: Perflutren Protein-Type A Microspheres Injectable Suspension

Arm A; Arm B

Dextrose DRUG

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.

Arm A; Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GE Healthcare: lead
• ICON Clinical Research: collaborator

Study Sites (1)

ICON Development Solutions

Elliott, Maryland, 21043, United States

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

FS 069; Glucose

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates

Results Point of Contact

• Title: Ruben Sheng, M.D.
• Organization: GE Healthcare

Rubin.Sheng@ge.com

1-609-514-6899

Study Officials

• Christopher Jefferds

  ICON Development Solutions

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2009
• First Posted: April 9, 2009
• Study Start: March 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: August 24, 2012
• Results First Posted: August 24, 2012

Record last verified: 2012-07

Locations

US (1)