Coronary Artery DiseasePhase 3NCT00595244
Safety and Efficacy Study of PB127 Ultrasound Contrast Agent in Patients With Suspected Coronary Artery Disease
A Phase 3 study testing PB127 for injectable suspension in people with Coronary Artery Disease, run by Point Biomedical at 15 sites in United States.
Trial summary
This trial is to compare PB127 echocardiography to other heart imaging studies. 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
- 456 participants
- Where
- 15 sitesUnited States
- Study dates
- Jul 2002to Oct 2003
- Phase
- Phase 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
- Stratum 1:
- Able to provide written informed consent
- Low (less than 10%) pre-test probability of CAD (Appendix D)
- Scheduled for clinically indicated stress echocardiography or stress SPECT within the 14 days prior to or following Study Day 1 (prior to coronary angiography) or coronary angiography within the 7 days following Study Day 1
- Technically adequate unreconstructed stress SPECT data or scheduled for clinically indicated stress SPECT within 14 days of Study Day 1 and prior to coronary angiography
- Adequate visualization of all myocardial segments in at least one view during non-contrast echocardiography (See Section 5.3.1)
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- No evidence of a right-to-left shunt during non-contrast echocardiography
- Stratum 2:
- Able to provide written informed consent
- Intermediate (10% to 90%) pre-test probability of CAD (Appendix D)
- Scheduled for clinically indicated coronary angiography within the 7 days following Study Day 1
- Technically adequate unreconstructed stress SPECT data or scheduled for stress SPECT within 14 days of Study Day 1 and prior to coronary angiography
- Adequate visualization of all myocardial segments in at least one view during non-contrast echocardiography (See Section 5.3.1)
- No evidence of a right-to-left shunt during non-contrast echocardiography
- Stratum 3:
- Able to provide written informed consent
- High (greater than 90%) pre-test probability of CAD (Appendix D)
- Scheduled for clinically indicated coronary angiography within the 7 days following Study Day 1
- Technically adequate unreconstructed stress SPECT data or scheduled for stress SPECT within 14 days of Study Day 1 and prior to coronary angiography
- Adequate visualization of all myocardial segments in at least one view during non-contrast echocardiography (See Section 5.3.1)
- No evidence of a right-to-left shunt during non-contrast echocardiography
Who cannot join
- Women who are pregnant or lactating
- Known hypersensitivity or known contraindication to:
- Dipyridamole
- Ultrasound contrast agents (including PB127 and excipients)
- Blood, blood products, albumin, egg, or protein
- Use of caffeine or xanthine containing products within the 24 hours prior to PB127 MCE
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- Previous exposure to PB127 Ultrasound Contrast Agent
- Heart transplant
- Known right-to-left shunt including atrial septal defect
- Current or history of uncontrolled ventricular tachycardia
- Current atrial fibrillation, atrial tachycardia, or atrial flutter
- Pacemaker or defibrillator
- Unstable cardiac status
- Unstable angina grade CCS Class IV severity with ongoing symptoms and/or ongoing infusion of intravenous nitroglycerin (See Appendix F)
- Second-degree or greater heart block
- Frequent (>60/hour) or symptomatic ventricular ectopics at baseline
- Hypertension (SPB >200 and/or DBP >110 mmHg on two consecutive readings within one hour of PB127 MCE)
- Hypotension (SPB <90 mmHg)
- Severe aortic stenosis (>100 mmHg peak transvalvar gradient or <0.6 cm2 estimated valve area)
- Pulmonary edema within the 7 days prior to Study Day 1
- Resting oxygen saturation of less than 90%
- Q-wave myocardial infarction within the 7 days prior to Study Day 1
- PTCA or CABG within the 7 days prior to Study Day 1
- Chronic Obstructive Pulmonary Disease (COPD) or bronchospastic airway disease which, in the opinion of the Investigator, is significant enough to contraindicate dipyridamole
- Known history of severe pulmonary hypertension characterized by estimated pulmonary artery systolic pressure of >50 mmHg
- Use of intravenous or intracoronary contrast agent other than thallium or technetium within the 24 hours prior to Study Day 1
- Liver disease (i.e., current or previous hepatic viral infection, chronic hepatitis) 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
- Medical conditions or other circumstances that would significantly decrease the chances of obtaining reliable data or achieving the study objectives (i.e., drug dependence, psychiatric disorder, dementia, or associated illness), extenuating circumstances, medical conditions that make it unlikely that a patient can complete the clinical trial or follow-up evaluations, or other reasons for expected poor compliance with the Investigator's instructions
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
New England Medical Center
Boston, Massachusetts, 02111
The Cleveland Clinic Foundation Department of Cardiology
Cleveland, Ohio, 44195
Long Beach VA Medical Center Cardiology Division
Long Beach, California, 90822
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
Virginia Mason Medical Center
Seattle, Washington, 98101
Harborview Medical Center Department of Cardiology
Seattle, Washington, 98104
The Center for Cardiovascular Studies Kramer & Crouse Cardiology
Shawnee Mission, Kansas, 66204
Northwest Cardiovascular Research Institute Spokane Cardiology
Spokane, Washington, 99204
St. Louis University Medical Center
St Louis, Missouri, 63110
Washington Hospital Center Cardiovascular Research Institute
Washington D.C., District of Columbia, 20010
About this study
Official title: CSP 127-006 A Phase 3 Clinical Trial to Assess Perfusion and Obstruction Identified by Non-Invasive Technology Using PB127 Ultrasound Contrast Agent in Patients With Suspected Obstructive Coronary Arter Disease
This trial is to compare PB127 echocardiography to other heart imaging studies.
- Conditions
- Coronary Artery Disease
- Being tested
- PB127 for injectable suspension
- Keywords
- Perfusion, Echocardiograpy, SPECT, angiography, Chest pain
- Medical subject headings
- Coronary Artery Disease, Chest Pain
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 Dextrose in Water 5% in glass bottles to be infused at 250 mL/hour until stead state achieve, 150 mL/hour during rest image acquisition, and 100-150 mL/hr during stress image acquistion. Single IV infusion, not to exceed 60 minutes.
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate the non-inferiority of the diagnostic performance of PB127 MCE versus stress SPECT in the detection and/or exclusion of significant obstructive CAD as defined by QCA or qualifying clinical outcome.
Measured: 90 days
Secondary outcomes (2)
To assess the concordance of PB127 MCE with stress SPECT in differentiating between reversible vs. fixed defects in patients with significant obstructive CAD
Measured: 28 days
To compare the diagnostic performance of PB127 MCE with stress SPECT in identifying the location of stenosis as identified by coronary angiography.
Measured: 28 days
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 startJul 2002
- Primary completionOct 2003
- Study completionOct 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 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 456 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
- NCT00595244
- Sponsor's protocol ID
- 127-006
- Status last verified
- Jul 2008
- First submitted
- 7 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
- CSP 127-006 A Phase 3 Clinical Trial to Assess Perfusion and Obstruction Identified by Non-Invasive Technology Using PB127 Ultrasound Contrast Agent in Patients With Suspected Obstructive Coronary Arter Disease
- ClinicalTrials.gov ID
- NCT00595244
- Acronym / sponsor ID
- 127-006
- Conditions
- Coronary Artery Disease
- Keywords
- Perfusion, Echocardiograpy, SPECT, angiography, Chest pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 456 participants (actual)
- Lead sponsor
- Point BiomedicalIndustry (pharma, biotech, devices)
- Study start
- Jul 2002
- Primary completion
- Oct 2003 (actual)
- Study completion
- Oct 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.
This trial is to compare PB127 echocardiography to other heart imaging studies.
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 (21 listed)
- Able to provide written informed consent
- Low (less than 10%) pre-test probability of CAD (Appendix D)
- Scheduled for clinically indicated stress echocardiography or stress SPECT within the 14 days prior to or following Study Day 1 (prior to coronary angiography) or coronary angiography within the 7 days following Study Day 1
- Technically adequate unreconstructed stress SPECT data or scheduled for clinically indicated stress SPECT within 14 days of Study Day 1 and prior to coronary angiography
- Adequate visualization of all myocardial segments in at least one view during non-contrast echocardiography (See Section 5.3.1)
Key exclusion criteria (31 listed)
- Women who are pregnant or lactating
- Known hypersensitivity or known contraindication to:
- Use of caffeine or xanthine containing products within the 24 hours prior to PB127 MCE
- Previous exposure to PB127 Ultrasound Contrast Agent
- Heart transplant
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 Dextrose in Water 5% in glass bottles to be infused at 250 mL/hour until stead state achieve, 150 mL/hour during rest image acquisition, and 100-150 mL/hr during stress image acquistion. Single IV infusion, not to exceed 60 minutes. | Drug | – |
Primary outcome
To demonstrate the non-inferiority of the diagnostic performance of PB127 MCE versus stress SPECT in the detection and/or exclusion of significant obstructive CAD as defined by QCA or qualifying clinical outcome.
Time frame: 90 days
2 secondary outcomes
To assess the concordance of PB127 MCE with stress SPECT in differentiating between reversible vs. fixed defects in patients with significant obstructive CAD
Time frame: 28 days
To compare the diagnostic performance of PB127 MCE with stress SPECT in identifying the location of stenosis as identified by coronary angiography.
Time frame: 28 days
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.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PB127 for injectable suspension in people with Coronary Artery Disease, run by Point Biomedical at 15 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 21 inclusion and 31 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 15 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 phase mean?
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?
To demonstrate the non-inferiority of the diagnostic performance of PB127 MCE versus stress SPECT in the detection and/or exclusion of significant obstructive CAD as defined by QCA or qualifying clinical outcome. (time frame: 90 days). 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.