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

This study has been terminated.
(Discontinued PB127 development program for business reasons)
Sponsor:
Information provided by:
Point Biomedical
ClinicalTrials.gov Identifier:
NCT00584714
First received: December 20, 2007
Last updated: July 1, 2008
Last verified: July 2008
History of Changes
  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

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

Resource links provided by NLM:

U.S. FDA Resources

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 ]

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

  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.
  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

No publications provided

Responsible Party: Tom Ottoboni PhD/Chief Operating Officer, POINT Biomedical Corp.
ClinicalTrials.gov Identifier: NCT00584714     History of Changes
Other Study ID Numbers: 127-014-A
Study First Received: December 20, 2007
Last Updated: July 1, 2008
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

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013