Safety and Efficacy Study of PB127 Ultrasound Contrast Agent in Patients With Suspected Coronary Artery Disease

PHASE3CompletedINTERVENTIONAL
Enrollment

456

Participants

Timeline

Start Date

July 31, 2002

Primary Completion Date

October 31, 2003

Study Completion Date

October 31, 2003

Conditions
Coronary Artery Disease
Interventions
DRUG

PB127 for injectable suspension

0.175 mg/kg diluted in 150 mL Dextrose in Water 5% in glass bottles to be infused at 250 mL/hour until stead state achieve, 150 mL/hour during rest image acquisition, and 100-150 mL/hr during stress image acquistion. Single IV infusion, not to exceed 60 minutes.

Trial Locations (15)

15213

University of Pittsburgh Cardiovascular Institute, Pittsburgh

20010

Washington Hospital Center Cardiovascular Research Institute, Washington D.C.

44195

The Cleveland Clinic Foundation Department of Cardiology, Cleveland

63110

St. Louis University Medical Center, St Louis

66204

The Center for Cardiovascular Studies Kramer & Crouse Cardiology, Shawnee Mission

78229

University of Texas Health Sciences Center at San Antonio, San Antonio

85018

Michael Morgan, MD, Phoenix

90822

Long Beach VA Medical Center Cardiology Division, Long Beach

92103

University of California San Diego Division of Cardiology, San Diego

94121

San Francisco VA Medical Center NCIRE, San Francisco

97239

Oregon Health Sciences University, Portland

98101

Virginia Mason Medical Center, Seattle

98104

Harborview Medical Center Department of Cardiology, Seattle

99204

Northwest Cardiovascular Research Institute Spokane Cardiology, Spokane

02111

New England Medical Center, Boston

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Point Biomedical

INDUSTRY