Long-Term Follow-up Study of Patients Who Received PB127 Ultrasound Imaging Agent

This study has been terminated.

Sponsored by:	Point Biomedical
Information provided by:	Point Biomedical
ClinicalTrials.gov Identifier:	NCT00584714

Purpose

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).

Condition
Coronary Artery Disease

MedlinePlus related topics: Coronary Artery Disease Ultrasound

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	Long-Term Follow-Up of Selected Patients Enrolled in Phase 3 Clinical Trial 127-014 Using PB127 Ultrasound Imaging Agent

Further study details as provided by Point Biomedical:

Primary Outcome Measures:

To collect longer-term follow-up clinical information on selected patients enrolled in Protocol 127-014 [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	300
Study Start Date:	October 2007
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
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.

Criteria

Inclusion Criteria:

Patients enrolled in Protocol 127-014 who

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00584714

Show 39 Study Locations

Sponsors and Collaborators

Point Biomedical

Investigators

Study Director:

Alexander Ehlgen, MD, PhD

POINT Biomedical Corp.

More Information

Responsible Party:	POINT Biomedical Corp. ( Tom Ottoboni PhD/Chief Operating Officer )
Study ID Numbers:	127-014-A
Study First Received:	December 20, 2007
Last Updated:	July 1, 2008
ClinicalTrials.gov Identifier:	NCT00584714
Health Authority:	United States: Food and Drug Administration

Keywords provided by Point Biomedical:

ultrasound
perfusion
SPECT
coronary artery disease

chest pain
low probability
angiography
clinical outcomes

Study placed in the following topic categories:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Vascular Diseases

Pain
Arteriosclerosis
Ischemia
Coronary Artery Disease
Chest Pain

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009