Coronary Artery DiseasePhase 2/3NCT00594698
Familiarization and Safety Study of PB127 Ultrasound Contrast Agent
A Phase 2/3 study testing PB127 for injectable suspension in people with Coronary Artery Disease, run by Point Biomedical at 34 sites in United States.
Trial summary
The purpose of this study is to evaluate preparation and administration of PB127, echocardiographic images obtained during PB127 administration, and evaluate the safety of PB127. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- PB127 for injectable suspension
- Type of treatment
- Injection or infusion
- How many people
- 150 participants
- Where
- 34 sitesUnited States
- Study dates
- Feb 2002to Sep 2003
- Phase
- Phase 2/3
- 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
Who may be able to join
- Able to provide written informed consent
- Scheduled for stress echocardiography, SPECT nuclear imaging and/or coronary angiography within the two weeks prior to or following Study Day 1
- Adequate visualization of all myocardial segments in at least one imaging plane during screening non-contrast echocardiogram
Who cannot join
- Women who were pregnant or lactating
- Known hypersensitivity or known contraindication to
- Dipyridamole
- Other ultrasound contrast agents
- Blood, blood products, albumin, egg, or protein
- Use of caffeine or xanthine containing products within the 24 hours prior to PB127 MPE
Show all 37Show fewer
- Frequent (> 60/hour) or symptomatic ventricular ectopics at baseline
- Atrial fibrillation
- Permanent pacemaker or defibrillator
- History of:
- Complex ventricular arrhythmia
- Chronic hepatitis
- Liver disease characterized by one or more of the following:
- current jaundice
- elevated bilirubin > upper limit of normal
- currently elevated hepatic enzymes > 2X upper limit of normal
- current or previous hepatic viral infection
- Chronic obstructive pulmonary disease (COPD) that, in the opinion of the Investigator, was significant enough to contraindicate dipyridamole
- Bronchospastic airway disease that, in the opinion of the Investigator, was significant enough to contraindicate dipyridamole
- Coronary artery bypass graft (CABG) within the 7 days prior to Study Day 1
- Heart transplant
- Q wave myocardial infarction within the 7 days prior to Study Day 1
- Cardiac intervention or surgery within the 7 days prior to Study Day 1
- Hypertension (systolic blood pressure [SBP] >200 mmHg and diastolic blood pressure [DBP] >110 mmHg)
- Hypotension (SBP <90 mmHg) documented within the 24 hours prior to Study Day 1
- Significant valvular disease
- Severe aortic stenosis (>100 mmHg peak transvalvar gradient or <0.6 cm2 estimated valve area)
- Severe mitral regurgitation (usual clinical criteria plus or minus any of the following: proximal isovelocity surface area [PISA] >1 cm2, forward transmitral gradient of >2 m/sec, unexplained systolic flow reversal or blunting in the pulmonary veins)
- Severe mitral stenosis (<1.0 cm2 estimated valve area)
- Congestive heart failure (New York Heart Association [NYHA] Class IV); NYHA classes are defined in Appendix D of the protocol (see Appendix 16.1.1)
- Pulmonary edema within the 7 days prior to Study Day 1
- Resting oxygen saturation of < 90%
- Pulmonary hypertension characterized by estimated pulmonary artery systolic pressure of >50 mmHg by echo or catheter criteria on Study Day 1
- Unstable angina, Canadian Cardiovascular Society (CCS) Class IV severity, with ongoing symptoms and/or ongoing infusion of intravenous nitroglycerin; CCS grading criteria are provided in Appendix E of the protocol (see Appendix 16.1.1)
- Second degree heart block or greater
- Use of intravenous or intracoronary contrast agent within the 24 hours prior to Study Day 1
- Medical conditions or other circumstances that would significantly decrease the chances of obtaining reliable data or achieving the study objectives, ie, drug dependence, psychiatric disorder, dementia, or other reasons for expected poor compliance with the Investigator's instructions; medical conditions, associated illness, or extenuating circumstances that made it unlikely that a patient can complete the clinical trial or follow-up evaluations
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
United States34 sites
Androscoggin Cardiovascular Associates
Auburn, Maine, 04210
Austin Heart
Austin, Texas, 78705
New England Medical Center
Boston, Massachusetts, 02111
University of Virginia Health System
Charlottesville, Virginia, 22908
University of Chicago Medical Center
Chicago, Illinois, 60637
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
MidWest Cardiologist Research
Columbus, Ohio, 43214
Dallas VA Medical Center
Dallas, Texas, 75216
Presbyterian Hospital of Dallas
Dallas, Texas, 75231
Endovascular Research, LLC
Eugene, Oregon, 97401
Methodist DeBakery Heart Center Cardiovascular Imaging Institute
Houston, Texas, 77030
Krannert Institute of Cardiology
Indianapolis, Indiana, 46202
Cardiovascular Consultants
Kansas City, Missouri, 64111
Long Beach VA Medical Center Cardiology Division
Long Beach, California, 90822
Mount Sinai Hospital
New York, New York, 10029
Michael Morgan, MD
Phoenix, Arizona, 85018
University of Pittsburgh Cardiovascular Institute
Pittsburgh, Pennsylvania, 15213
Oregon Health Sciences University
Portland, Oregon, 97239
University of Texas Health Sciences Center at San Antonio
San Antonio, Texas, 78229
University of California San Diego Division of Cardiology
San Diego, California, 92103
San Francisco VA Medical Center NCIRE
San Francisco, California, 94121
University of California San Francisco
San Francisco, California, 94143
Heartcare, P.C.
Scottsdale, Arizona, 85258
Mayo Clinic Scottsdale
Scottsdale, Arizona, 85259
Virginia Mason Medical Center
Seattle, Washington, 98101
Harborview Medical Center Department of Cardiology
Seattle, Washington, 98104
The Center for Cardiovascular Studies Kramer and Crouse Cardiology
Shawnee Mission, Kansas, 66204
Maine Cardiology Associates
South Portland, Maine, 04106
Inland Cardiology
Spokane, Washington, 99204
Northwest Cardiovascular Research Institute Spokane Cardiology
Spokane, Washington, 99204
St. Louis University Medical Center
St Louis, Missouri, 63110
Washington University School of Medicine
St Louis, Missouri, 63110
Stanford University Medical Center
Stanford, California, 94305
Washington Hospital Center Cardiovascular Research Institute
Washington D.C., District of Columbia, 20010
About this study
Official title: A Familiarization and Safety Study of Myocardial Perfusion Contrast Echocardiography With PB127 Ultrasound Contrast Agent in Patients With Suspected Obstructive Coronary Artery Disease
The purpose of this study is to evaluate preparation and administration of PB127, echocardiographic images obtained during PB127 administration, and evaluate the safety of PB127.
Read the detailed description
The primary objectives of this clinical trial are:
- To train potential Phase 3 investigational sites in the preparation and andministration of PB127
- To train potential Phase 3 investigational sites in the acquisition of adequate images
- To collect additional safety information regarding intravenous administration of PB127
- To obtain a larger sample of images obtained with the Acuson Sequoia ultrasound system.
- Conditions
- Coronary Artery Disease
- Being tested
- PB127 for injectable suspension
- Keywords
- Perfusion, Echocardiography, Cardiac angiography, SPECT
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PB127 for injectable suspensionDrug
Also called CARDIOsphere®
0.175 mg/kg diluted in 150 mL 5% Dextrose for Injection in glass bottles, to be administered as a single continuous infusion during image acquisition. Infusion time not to exceed 60 minutes
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical adequacy and diagnostic quality of PB127 images
Measured: 24 hours
Secondary outcomes (1)
Compliance with image acquisition and Pb127 administration procedures
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2008 (estimated)
- Study startFeb 2002
- Primary completionSep 2003
- Study completionSep 2003
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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
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
- NCT00594698
- Sponsor's protocol ID
- 127-005
- Status last verified
- Jan 2008
- First submitted
- 4 Jan 2008
- Last updated
- 3 Jul 2008
- Results posted
- No
- Data monitoring committee
- Yes
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
- A Familiarization and Safety Study of Myocardial Perfusion Contrast Echocardiography With PB127 Ultrasound Contrast Agent in Patients With Suspected Obstructive Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT00594698
- Acronym / sponsor ID
- 127-005
- Conditions
- Coronary Artery Disease
- Keywords
- Perfusion, Echocardiography, Cardiac angiography, SPECT
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Point BiomedicalIndustry (pharma, biotech, devices)
- Study start
- Feb 2002
- Primary completion
- Sep 2003 (actual)
- Study completion
- Sep 2003 (actual)
- First posted
- 16 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 evaluate preparation and administration of PB127, echocardiographic images obtained during PB127 administration, and evaluate the safety of PB127.
Detailed description
The primary objectives of this clinical trial are:
- To train potential Phase 3 investigational sites in the preparation and andministration of PB127
- To train potential Phase 3 investigational sites in the acquisition of adequate images
- To collect additional safety information regarding intravenous administration of PB127
- To obtain a larger sample of images obtained with the Acuson Sequoia ultrasound system.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Able to provide written informed consent
- Scheduled for stress echocardiography, SPECT nuclear imaging and/or coronary angiography within the two weeks prior to or following Study Day 1
- Adequate visualization of all myocardial segments in at least one imaging plane during screening non-contrast echocardiogram
Key exclusion criteria (37 listed)
- Women who were pregnant or lactating
- Known hypersensitivity or known contraindication to
- Use of caffeine or xanthine containing products within the 24 hours prior to PB127 MPE
- Frequent (> 60/hour) or symptomatic ventricular ectopics at baseline
- Atrial fibrillation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PB127 for injectable suspensionAlso: CARDIOsphere®0.175 mg/kg diluted in 150 mL 5% Dextrose for Injection in glass bottles, to be administered as a single continuous infusion during image acquisition. Infusion time not to exceed 60 minutes | Drug | – |
Primary outcome
Technical adequacy and diagnostic quality of PB127 images
Time frame: 24 hours
1 secondary outcome
Compliance with image acquisition and Pb127 administration procedures
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2008.
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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.
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing PB127 for injectable suspension in people with Coronary Artery Disease, run by Point Biomedical at 34 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 3 inclusion and 37 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: finished, 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 34 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Technical adequacy and diagnostic quality of PB127 images (time frame: 24 hours). 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.