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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 31, 2014