Coronary Artery DiseaseNCT00584714
Long-Term Follow-up Study of Patients Who Received PB127 Ultrasound Imaging Agent
An observational study of Coronary Artery Disease, run by Point Biomedical at 39 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 300 participants
- Where
- 39 sitesUnited States
- Study dates
- Oct 2007to Jul 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
39 sites in 1 country.
39 sites in 1 country
United States39 sites
Androscoggin Cardiovascular Associates
Auburn, Maine, 04210
Seton Healthcare Network Brackenridge Hospital
Austin, Texas, 78701
Austin Heart
Austin, Texas, 78705
Brigham & Women's Hosptial
Boston, Massachusetts, 02115
Connecticut Clinical Research
Bridgeport, Connecticut, 06606
Cardiovascular Associates of the Peninsula
Burlingame, California, 94010
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
The Cleveland Clinic Foundation Department of Cardiology
Cleveland, Ohio, 44195
Ohio State University College of Medicine and Public Health
Columbus, Ohio, 43210
Henry Ford Hospital
Detroit, Michigan
Duke University Medical Center
Durham, North Carolina, 27710
Consultants in Cardiology
Fort Worth, Texas, 76104
University of Texas Division of Cardiology
Galveston, Texas, 77555
Carolina Cardiology Associates
High Point, North Carolina, 27262
Methodist DeBakery Heart Center Cardiovascular Imaging Institute
Houston, Texas, 77030
University of Texas Health Science Center Memorial Hermann Heart & Vascular Institute
Houston, Texas, 77030
Cardiovascular Consultants
Kansas City, Missouri, 64111
Long Beach VA Medical Center Cardiology Division
Long Beach, California, 90822
Cedars Sinai Medical Center Division of Cardiology
Los Angeles, California, 90048
North Shore University Hospital
Manhasset, New York, 11030
St. Luke's Roosevelt Hospital Echocardiography Lab
New York, New York, 10025
Alfieri Cardiology
Newark, Delaware, 19713
Midwest Cardiology Associates
Overland Park, Kansas, 66209
Western Baptist Hospital The Heart Group
Paducah, Kentucky, 42001
University of Pittsburgh Cardiovascular Institute
Pittsburgh, Pennsylvania, 15213
Mayo Clinic Department of Cardiology
Rochester, Minnesota, 55905
Sutter Roseville Medical Center
Roseville, California, 95661
University of California San Diego Division of Cardiology
San Diego, California, 92103
San Francisco VA Medical Center NCIRE
San Francisco, California, 94121
Harborview Medical Center Department of Cardiology
Seattle, Washington, 98104
The Center for Cardiovascular Studies Kramer & Crouse Cardiology
Shawnee Mission, Kansas, 66204
Maine Cardiology Associates
South Portland, Maine, 04106
Heart Clinics Northwest
Spokane, Washington, 99204
Inland Cardiology
Spokane, Washington, 99204
Northwest Cardiovascular Research Institute Spokane Cardiology
Spokane, Washington, 99204
St. Louis University Medical Center
St Louis, Missouri, 63110
Stonybrook University Medical Center
Stony Brook, New York, 11794
University of Arizona Saver Heart Clinic
Tucson, Arizona, 85724
Washington Hospital Center Cardiovascular Research Institute
Washington D.C., District of Columbia, 20010
About this study
Official title: Long-Term Follow-Up of Selected Patients Enrolled in Phase 3 Clinical Trial 127-014 Using PB127 Ultrasound Imaging Agent
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).
- Conditions
- Coronary Artery Disease
- Keywords
- ultrasound, perfusion, SPECT, coronary artery disease, chest pain, low probability, angiography, clinical outcomes
- Medical subject headings
- Coronary Artery Disease, Chest Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
To collect longer-term follow-up clinical information on selected patients enrolled in Protocol 127-014
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2008 (estimated)
- Study startOct 2007
- Primary completionJul 2008
- Study completionJul 2008
Why it stopped: Discontinued PB127 development program for business reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Point Biomedical
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Alexander Ehlgen, MD, PhD, Study director, POINT Biomedical Corp.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00584714
- Sponsor's protocol ID
- 127-014-A
- Status last verified
- Jul 2008
- First submitted
- 20 Dec 2007
- Last updated
- 3 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Follow-Up of Selected Patients Enrolled in Phase 3 Clinical Trial 127-014 Using PB127 Ultrasound Imaging Agent
- ClinicalTrials.gov ID
- NCT00584714
- Acronym / sponsor ID
- 127-014-A
- Conditions
- Coronary Artery Disease
- Keywords
- ultrasound, perfusion, SPECT, coronary artery disease, chest pain, low probability, angiography, clinical outcomes
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Discontinued PB127 development program for business reasons
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Point BiomedicalIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 2 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To collect longer-term follow-up clinical information on selected patients enrolled in Protocol 127-014
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Discontinued PB127 development program for business reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2008.
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Ehlgen, MD, PhD study director
POINT Biomedical Corp.
39 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Point Biomedical at 39 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Discontinued PB127 development program for business reasons). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To collect longer-term follow-up clinical information on selected patients enrolled in Protocol 127-014 (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2008.