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

Coronary Artery Disease Clinical Trial

— POINT II  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00584896
• Other study ID #: 127-014
• Status: Terminated
• Phase: Phase 3
• First received: December 20, 2007
• Last updated: July 1, 2008
• Start date: October 2007
• Est. completion date: July 2008

Study information

• Verified date: July 2008
• Source: Point Biomedical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1000
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

1. 18 years old or older and able to provide written informed consent;

2. All subjects must be scheduled for or have undergone SPECT within 28 days prior to or following Study Day 1

3. Subjects with very low/low pre-test probability of coronary artery disease must consent to participate in the extension trial 127-014-A

4. Subjects with very low/low pre-test probability of coronary artery disease must not have a current diagnosis of obstructive CAD on angiogram or prior MI

5. Subjects with very low/low pre-test probability of coronary artery disease with a current diagnosis of obstructive CAD on angiogram or prior MI may be enrolled into Stratum 2

6. Subjects with intermediate or high pre-test probability of coronary artery disease must be scheduled for coronary angiography within the 28 days following Study Day 1

7. Sinus rhythm at the time of the study procedure

8. Adequate visualization of myocardial segments

9. Appropriate candidate for stress testing according to ACC/AHA Guidelines for Exercise Testing

Exclusion Criteria:

1. Women who are pregnant or lactating

2. Known hypersensitivity or known contraindication to:

1. Dipyridamole

2. Ultrasound contrast agents (including PB127 and excipients)

3. Blood, blood products, albumin, egg, or protein

3. Use of caffeine or xanthine containing products within the 24 hours prior to Study Day 1

4. Previous exposure to PB127 Ultrasound Contrast Agent

5. Major surgery within 7 days prior to Study Day 1 (requiring general anesthesia and/or overnight stay)

6. Heart transplant or history of CABG

7. Known hemodynamically significant or symptomatic right-to-left shunt (including shunts that are associated with prior TIAs or strokes)

8. Recent history of sustained ventricular tachycardia

9. Pacemaker or defibrillator

10. Unstable cardiac status

1. 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

2. Decompensated heart failure

3. Second-degree or greater heart block, sick sinus syndrome

4. Frequent (>60/hour) or symptomatic ventricular ectopics at baseline

5. Hypertension (SBP >200 and/or DBP >110 mmHg on two consecutive readings within one hour of PB127 MPE)

6. Hypotension (SBP <90 mmHg)

7. Severe aortic stenosis (>40 mmHg mean gradient or <0.6 cm2/m2 valve area index)

8. Pulmonary edema within the 7 days prior to Study Day 1

9. Resting oxygen saturation of less than 90% on room air

11. Myocardial infarction or cerebral vascular accident / transient ischemic attack within the 28 days prior to Study Day 1

12. Chronic Obstructive Pulmonary Disease (COPD) or bronchospastic airway disease, which in the opinion of the Investigator, is significant enough to contraindicate dipyridamole

13. Known history of severe pulmonary hypertension characterized by estimated pulmonary artery systolic pressure of >50 mmHg

14. Liver disease characterized by one or more of the following

1. Current jaundice

2. Elevated bilirubin > upper limit of normal

3. Currently elevated hepatic enzymes > 2X upper limit of normal

4. Current or previous hepatic viral infection (not including hepatitis A)

5. Chronic hepatitis

15. 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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• PB127 for Injectable Suspension
0.062 mg/kg continuous IV infusion (100-250 mL/hr) during echocardiography, not to exceed 60 minutes infusion, single dose.

Locations

Country	Name	City	State
United States	Androscoggin Cardiovascular Associates	Auburn	Maine
United States	Austin Heart	Austin	Texas
United States	Seton Healthcare Network Brackenridge Hospital	Austin	Texas
United States	Brigham & Women's Hosptial	Boston	Massachusetts
United States	Connecticut Clinical Research	Bridgeport	Connecticut
United States	Cardiovascular Associates of the Peninsula	Burlingame	California
United States	Northwestern University Feinberg School of Medicine	Chicago	Illinois
United States	The Cleveland Clinic Foundation Department of Cardiology	Cleveland	Ohio
United States	Ohio State University College of Medicine and Public Health	Columbus	Ohio
United States	Henry Ford Hospital	Detroit	Michigan
United States	Duke University Medical Center	Durham	North Carolina
United States	Consultants in Cardiology	Fort Worth	Texas
United States	University of Texas Division of Cardiology	Galveston	Texas
United States	Carolina Cardiology Associates	High Point	North Carolina
United States	Methodist DeBakery Heart Center Cardiovascular Imaging Institute	Houston	Texas
United States	University of Texas Health Science Center Memorial Hermann Heart & Vascular Institute	Houston	Texas
United States	Cardiovascular Consultants	Kansas City	Missouri
United States	Long Beach VA Medical Center Cardiology Division	Long Beach	California
United States	Cedars Sinai Medical Center Division of Cardiology	Los Angeles	California
United States	North Shore University Hospital	Manhasset	New York
United States	St. Luke's Roosevelt Hospital Echocardiography Lab	New York	New York
United States	Alfieri Cardiology	Newark	Delaware
United States	University of Oklahoma Health Sciences Center VA Medical Center	Oklahoma City	Oklahoma
United States	Midwest Cardiology Associates	Overland Park	Kansas
United States	Western Baptist Hospital The Heart Group	Paducah	Kentucky
United States	University of Pittsburgh Cardiovascular Institute	Pittsburgh	Pennsylvania
United States	Mayo Clinic Department of Cardiology	Rochester	Minnesota
United States	Sutter Roseville Medical Center	Roseville	California
United States	University of California San Diego Division of Cardiology	San Diego	California
United States	San Francisco VA Medical Center NCIRE	San Francisco	California
United States	Harborview Medical Center Department of Cardiology	Seattle	Washington
United States	The Center for Cardiovascular Studies Kramer & Crouse Cardiology	Shawnee Mission	Kansas
United States	Maine Cardiology Associates	South Portland	Maine
United States	Heart Clinics Northwest	Spokane	Washington
United States	Inland Cardiology	Spokane	Washington
United States	Northwest Cardiovascular Research Institute Spokane Cardiology	Spokane	Washington
United States	St. Louis University Medical Center	St. Louis	Missouri
United States	Stonybrook University Medical Center	Stonybrook	New York
United States	University of Arizona Saver Heart Clinic	Tucson	Arizona
United States	Washington Hospital Center Cardiovascular Research Institute	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Point Biomedical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		72 hours, 6 months	Yes
Secondary	To compare the diagnostic performance of PB127 MPE to SPECT for the detection and/or exclusion of significant obstructive coronary artery disease.		72 hours, 6 months	No
Secondary	To assess the concordance of PB127 MPE with SPECT in the differentiation of defect type (fixed versus reversible) in patients with significant obstructive CAD.		72 hours, 6 months	No
Secondary	To evaluate the diagnostic performance characteristics of PB127 MPE for identifying the location of significant obstructive CAD as defined by quantitative coronary angiography		72 hours	No
Secondary	To assess the change in diagnostic certainty when PB127 MPE and relevant clinical information are combined over relevant clinical information alone.		72 hours, 6 months	No