Coronary Artery DiseasePhase 3POINT IINCT00584896

Safety and Efficacy Study of PB127 Ultrasound Contrast Agent for Diagnosis of Coronary Artery Disease

A Phase 3 study testing PB127 for Injectable Suspension in people with Coronary Artery Disease, run by Point Biomedical at 40 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of this study is to determine if the use of PB127 with cardiac ultrasound assists in the diagnosis or exclusion of coronary artery disease. 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: 1,000 participants
Where: 40 sitesUnited States
Study dates: Oct 2007to Jul 2008
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

None listed.

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 Study Day 1

Show all 32Show fewer

Previous exposure to PB127 Ultrasound Contrast Agent
Major surgery within 7 days prior to Study Day 1 (requiring general anesthesia and/or overnight stay)
Heart transplant or history of CABG
Known hemodynamically significant or symptomatic right-to-left shunt (including shunts that are associated with prior TIAs or strokes)
Recent history of sustained ventricular tachycardia
Pacemaker or defibrillator
Unstable cardiac status
Unstable angina grade CCS Class IV severity (any physical activity causes limiting symptoms; symptoms may be present at rest in a patient with prior exertional angina) with ongoing symptoms and/or ongoing infusion of intravenous nitroglycerin
Decompensated heart failure
Second-degree or greater heart block, sick sinus syndrome
Frequent (>60/hour) or symptomatic ventricular ectopics at baseline
Hypertension (SBP >200 and/or DBP >110 mmHg on two consecutive readings within one hour of PB127 MPE)
Hypotension (SBP <90 mmHg)
Severe aortic stenosis (>40 mmHg mean gradient or <0.6 cm2/m2 valve area index)
Pulmonary edema within the 7 days prior to Study Day 1
Resting oxygen saturation of less than 90% on room air
Myocardial infarction or cerebral vascular accident / transient ischemic attack within the 28 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
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 (not including hepatitis A)
Chronic hepatitis
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

40 sites in 1 country.

City, postcode or hospital

40 sites in 1 country

United States40 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
University of Oklahoma Health Sciences Center VA Medical Center
Oklahoma City, Oklahoma
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

Other trials in United States

About this study

Official title: 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 Artery Disease II

The purpose of this study is to determine if the use of PB127 with cardiac ultrasound assists in the diagnosis or exclusion of coronary artery disease.

Conditions: Coronary Artery Disease
Being tested: PB127 for Injectable Suspension
Keywords: heart disease, coronary artery disease, echocardiogram, ultrasound, angiogram, SPECT, chest pain, perfusion
Medical subject headings: Coronary Artery Disease, Heart Diseases, 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 CARDIOshpere®
0.062 mg/kg continuous IV infusion (100-250 mL/hr) during echocardiography, not to exceed 60 minutes infusion, single dose.

What is being measured

The primary outcome is the main question the study is designed to answer.

To evaluate the diagnostic performance of PB127 MPE for the detection and/or exclusion of significant obstructive coronary artery disease as defined by qualitative coronary angiography or qualifying clinical outcome
Measured: 72 hours, 6 months

Secondary outcomes (4)

To compare the diagnostic performance of PB127 MPE to SPECT for the detection and/or exclusion of significant obstructive coronary artery disease.
Measured: 72 hours, 6 months
To assess the concordance of PB127 MPE with SPECT in the differentiation of defect type (fixed versus reversible) in patients with significant obstructive CAD.
Measured: 72 hours, 6 months
To evaluate the diagnostic performance characteristics of PB127 MPE for identifying the location of significant obstructive CAD as defined by quantitative coronary angiography
Measured: 72 hours
To assess the change in diagnostic certainty when PB127 MPE and relevant clinical information are combined over relevant clinical information alone.
Measured: 72 hours, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2007Jul 2008

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: Interventional
Phase: Phase 3
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 1,000 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00584896
Sponsor's protocol ID: 127-014
Acronym: POINT II
Status last verified: Jul 2008
First submitted: 20 Dec 2007
Last updated: 3 Jul 2008
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Coronary Artery Disease trials

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 3 Clinical Trial to Assess Perfusion and Obstruction Identified by Non-Invasive Technology Using PB127 Ultrasound Contrast Agent in Patients With Suspected Obstructive Coronary Artery Disease II
ClinicalTrials.gov ID: NCT00584896
Acronym / sponsor ID: POINT II / 127-014
Conditions: Coronary Artery Disease
Keywords: heart disease, coronary artery disease, echocardiogram, ultrasound, angiogram, SPECT, chest pain, perfusion
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Discontinued PB127 development program for business reasons
Enrolment: 1,000 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 determine if the use of PB127 with cardiac ultrasound assists in the diagnosis or exclusion of coronary artery disease.

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 (0 listed)

Key exclusion criteria (32 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 Study Day 1
Previous exposure to PB127 Ultrasound Contrast Agent
Major surgery within 7 days prior to Study Day 1 (requiring general anesthesia and/or overnight stay)

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: CARDIOshpere®0.062 mg/kg continuous IV infusion (100-250 mL/hr) during echocardiography, not to exceed 60 minutes infusion, single dose.	Drug	–

Primary outcome

To evaluate the diagnostic performance of PB127 MPE for the detection and/or exclusion of significant obstructive coronary artery disease as defined by qualitative coronary angiography or qualifying clinical outcome
Time frame: 72 hours, 6 months

4 secondary outcomes

To compare the diagnostic performance of PB127 MPE to SPECT for the detection and/or exclusion of significant obstructive coronary artery disease.
Time frame: 72 hours, 6 months
To assess the concordance of PB127 MPE with SPECT in the differentiation of defect type (fixed versus reversible) in patients with significant obstructive CAD.
Time frame: 72 hours, 6 months
To evaluate the diagnostic performance characteristics of PB127 MPE for identifying the location of significant obstructive CAD as defined by quantitative coronary angiography
Time frame: 72 hours
To assess the change in diagnostic certainty when PB127 MPE and relevant clinical information are combined over relevant clinical information alone.
Time frame: 72 hours, 6 months

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

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Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
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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

40 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 40 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 0 inclusion and 32 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 40 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 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 evaluate the diagnostic performance of PB127 MPE for the detection and/or exclusion of significant obstructive coronary artery disease as defined by qualitative coronary angiography or qualifying clinical outcome (time frame: 72 hours, 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00584896.

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.