Coronary Artery DiseasePhase 2NCT00487903
Evaluation and Optimization of PB127 Myocardial Perfusion Echocardiography on Ultrasound Systems
A Phase 2 study testing PB127 for Injectable Suspension in people with Coronary Artery Disease and Healthy, run by Point Biomedical at 3 sites in United States.
Trial summary
The purpose of this clinical trial is to evaluate various commercially available ultrasound systems and to identify imaging parameters to be used with these systems (along with the contrast agent PB127) as well as to further evaluate the safety of PB127. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease, Healthy
- What is being tested?
- PB127 for Injectable Suspension
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2007to Mar 2008
- Phase
- Phase 2
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Men and women
- Normal volunteers (18 30 years old), with no history of CAD
- Patients (≥ 18 years old) with known or suspected CAD, scheduled for or undergone clinically indicated coronary angiography within 28 days prior to or following Study Day 1
Who cannot join
- Unable to provide written informed consent
- 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 whites, or protein
Show all 29Show fewer
- Use of caffeine or xanthine containing products within the 24 hours prior to PB127 administration on Study Day 1
- Previous exposure to PB127
- Inadequate echocardiographic windows
- Heart transplant
- Known right to left shunt, including atrial septal defect
- History of CABG
- Current uncontrolled ventricular tachycardia, atrial fibrillation, atrial tachycardia, or atrial flutter
- Pacemaker or defibrillator
- Unstable angina grade CCS Class IV severity with ongoing symptoms and/or ongoing infusion of IV nitroglycerin
- Second degree or greater heart block
- Hypertension (SPB >200 and/or DBP >110 mmHg on two consecutive readings within 1 hour prior to PB127 administration)
- Hypotension (SPB <90 mmHg on two consecutive readings within 1 hour prior to PB127 administration)
- 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 MI within the 7 days prior to Study Day 1
- PTCA within the 28 days prior to Study Day 1
- Chronic obstructive pulmonary disease 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
- Liver disease, characterized by or including one or more of the following
- Elevated total bilirubin >upper limit of normal
- Currently elevated hepatic enzymes >3X 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 or 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 clinical investigator's instructions
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Baylor Research Institute
Dallas, Texas, 75226
Duke University Medical Center
Durham, North Carolina, 27710
Midwest Cardiology Associates
Overland Park, Kansas, 66209
About this study
Official title: A Phase 2 Trial of PB127 Myocardial Perfusion Echocardiography to Evaluate and Optimize Additional Ultrasound Imaging Systems
The purpose of this clinical trial is to evaluate various commercially available ultrasound systems and to identify imaging parameters to be used with these systems (along with the contrast agent PB127) as well as to further evaluate the safety of PB127.
- Conditions
- Coronary Artery Disease, Healthy
- Being tested
- PB127 for Injectable Suspension
- Keywords
- Coronary Artery Disease, Echocardiogram, Contrast, Perfusion, Ultrasound, Normal volunteers
- 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®
0.062 mg/kg continuous IV (100-250 mL/hr) during echocardiogram, single dose, infusion not to exceed 60 minutes.
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of optimal machine settings and imaging parameters for myocardial perfusion for a variety of ultrasound imaging systems to be used in upcoming clinical trials
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 posted19 Jun 2007 (estimated)
- Study startSep 2007
- Primary completionMar 2008
- Study completionMar 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 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
- NCT00487903
- Sponsor's protocol ID
- 127-015
- Status last verified
- Jul 2008
- First submitted
- 15 Jun 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
- A Phase 2 Trial of PB127 Myocardial Perfusion Echocardiography to Evaluate and Optimize Additional Ultrasound Imaging Systems
- ClinicalTrials.gov ID
- NCT00487903
- Acronym / sponsor ID
- 127-015
- Conditions
- Coronary Artery Disease, Healthy
- Keywords
- Coronary Artery Disease, Echocardiogram, Contrast, Perfusion, Ultrasound, Normal volunteers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Discontinued PB127 development program for business reasons
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Point BiomedicalIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 19 Jun 2007 (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 clinical trial is to evaluate various commercially available ultrasound systems and to identify imaging parameters to be used with these systems (along with the contrast agent PB127) as well as to further evaluate the safety of PB127.
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
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1. Men and women
- Normal volunteers (18 30 years old), with no history of CAD
- Patients (≥ 18 years old) with known or suspected CAD, scheduled for or undergone clinically indicated coronary angiography within 28 days prior to or following Study Day 1
Key exclusion criteria (29 listed)
- Unable to provide written informed consent
- 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 administration on Study Day 1
- Previous exposure to PB127
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®0.062 mg/kg continuous IV (100-250 mL/hr) during echocardiogram, single dose, infusion not to exceed 60 minutes. | Drug | – |
Primary outcome
Determination of optimal machine settings and imaging parameters for myocardial perfusion for a variety of ultrasound imaging systems to be used in upcoming clinical trials
Time frame: 24 hours
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.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PB127 for Injectable Suspension in people with Coronary Artery Disease and Healthy, run by Point Biomedical at 3 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 29 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 3 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 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?
Determination of optimal machine settings and imaging parameters for myocardial perfusion for a variety of ultrasound imaging systems to be used in upcoming clinical trials (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.