Clinical trial NCT00584714: Long-Term Follow-up Study of Patients Who Received PB127 Ultrasound Imaging Agent
Official title: Long-Term Follow-Up of Selected Patients Enrolled in Phase 3 Clinical Trial 127-014 Using PB127 Ultrasound Imaging Agent
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Coronary Artery Disease
Keywords: ultrasound
perfusion
SPECT
coronary artery disease
chest pain
low probability
angiography
clinical outcomes
Lead sponsor: Point Biomedical
Sponsor class: INDUSTRY
First posted: 2008-01-02
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with low/very low pre-test probability of coronary artery disease enrolled in Protocol 127-014 who did not have or were not schedule to undergo coronary angiography at the time of enrollment and did not have a clinical outcome during the initial 6 month follow-up period.

Brief summary: The purpose of this study is to collect longer term follow-up information concerning health and survival on selected patients who received PB127 for injectable suspension in the pivotal trial (127-014).


Eligibility criteria: Inclusion Criteria:

Patients enrolled in Protocol 127-014 who

1. Were enrolled in Stratum 1
2. Did not undergo angiography during study evaluation
3. Did not have a clinical oucome during the initial 6 month follow-up period as described in Protocol 127-014.

Primary outcomes:
measure: To collect longer-term follow-up clinical information on selected patients enrolled in Protocol 127-014
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona Saver Heart Clinic
state: Arizona
city: Burlingame
country: United States
facility: Cardiovascular Associates of the Peninsula
state: California
city: Long Beach
country: United States
facility: Long Beach VA Medical Center Cardiology Division
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center Division of Cardiology
state: California
city: Roseville
country: United States
facility: Sutter Roseville Medical Center
state: California
city: San Diego
country: United States
facility: University of California San Diego Division of Cardiology
state: California
city: San Francisco
country: United States
facility: San Francisco VA Medical Center NCIRE
state: California
city: Bridgeport
country: United States
facility: Connecticut Clinical Research
state: Connecticut
city: Newark
country: United States
facility: Alfieri Cardiology
state: Delaware
city: Washington
country: United States
facility: Washington Hospital Center Cardiovascular Research Institute
state: District of Columbia
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
city: Overland Park
country: United States
facility: Midwest Cardiology Associates
state: Kansas
city: Shawnee Mission
country: United States
facility: The Center for Cardiovascular Studies Kramer & Crouse Cardiology
state: Kansas
city: Paducah
country: United States
facility: Western Baptist Hospital The Heart Group
state: Kentucky
city: Auburn
country: United States
facility: Androscoggin Cardiovascular Associates
state: Maine
city: South Portland
country: United States
facility: Maine Cardiology Associates
state: Maine
city: Boston
country: United States
facility: Brigham & Women's Hosptial
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic Department of Cardiology
state: Minnesota
city: Kansas City
country: United States
facility: Cardiovascular Consultants
state: Missouri
city: St. Louis
country: United States
facility: St. Louis University Medical Center
state: Missouri
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: New York
country: United States
facility: St. Luke's Roosevelt Hospital Echocardiography Lab
state: New York
city: Stonybrook
country: United States
facility: Stonybrook University Medical Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: High Point
country: United States
facility: Carolina Cardiology Associates
state: North Carolina
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation Department of Cardiology
state: Ohio
city: Columbus
country: United States
facility: Ohio State University College of Medicine and Public Health
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh Cardiovascular Institute
state: Pennsylvania
city: Austin
country: United States
facility: Seton Healthcare Network Brackenridge Hospital
state: Texas
city: Austin
country: United States
facility: Austin Heart
state: Texas
city: Fort Worth
country: United States
facility: Consultants in Cardiology
state: Texas
city: Galveston
country: United States
facility: University of Texas Division of Cardiology
state: Texas
city: Houston
country: United States
facility: Methodist DeBakery Heart Center Cardiovascular Imaging Institute
state: Texas
city: Houston
country: United States
facility: University of Texas Health Science Center Memorial Hermann Heart & Vascular Institute
state: Texas
city: Seattle
country: United States
facility: Harborview Medical Center Department of Cardiology
state: Washington
city: Spokane
country: United States
facility: Heart Clinics Northwest
state: Washington
city: Spokane
country: United States
facility: Inland Cardiology
state: Washington
city: Spokane
country: United States
facility: Northwest Cardiovascular Research Institute Spokane Cardiology
state: Washington
Study officials:
affiliation: POINT Biomedical Corp.
name: Alexander Ehlgen, MD, PhD
role: STUDY_DIRECTOR
References: