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

Phase 3

Terminated

• Conditions: Coronary Artery Disease

• Registration Number: NCT00584896
• Lead Sponsor: Point Biomedical

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-12-20
• Study First Submitted QC: 2007-12-20
• Study First Posted: 2008-01-02
• Status Verified: 2008-07
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Last Update Submitted: 2008-07-01
• Last Update Posted: 2008-07-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

Not provided

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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
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
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
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

Trial Locations

Locations (40)

University of Arizona Saver Heart Clinic; 🇺🇸 Tucson, Arizona, United States

Cardiovascular Associates of the Peninsula; 🇺🇸 Burlingame, California, 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

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

Connecticut Clinical Research; 🇺🇸 Bridgeport, Connecticut, United States

Alfieri Cardiology; 🇺🇸 Newark, Delaware, United States

Washington Hospital Center Cardiovascular Research Institute; 🇺🇸 Washington, District of Columbia, United States

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