Familiarization and Safety Study of PB127 Ultrasound Contrast Agent

Coronary Artery Disease Clinical Trial

Official title:

A Familiarization and Safety Study of Myocardial Perfusion Contrast Echocardiography With PB127 Ultrasound Contrast Agent in Patients With Suspected Obstructive Coronary Artery Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00594698
• Other study ID #: 127-005
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 4, 2008
• Last updated: July 1, 2008
• Start date: February 2002
• Est. completion date: September 2003

Study information

• Verified date: January 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 evaluate preparation and administration of PB127, echocardiographic images obtained during PB127 administration, and evaluate the safety of PB127.

Description:

The primary objectives of this clinical trial are:

1. To train potential Phase 3 investigational sites in the preparation and andministration of PB127

2. To train potential Phase 3 investigational sites in the acquisition of adequate images

3. To collect additional safety information regarding intravenous administration of PB127

4. To obtain a larger sample of images obtained with the Acuson Sequoia ultrasound system.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: September 2003
• Est. primary completion date: September 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Able to provide written informed consent

2. Scheduled for stress echocardiography, SPECT nuclear imaging and/or coronary angiography within the two weeks prior to or following Study Day 1

3. Adequate visualization of all myocardial segments in at least one imaging plane during screening non-contrast echocardiogram

Exclusion Criteria:

1. Women who were pregnant or lactating

2. Known hypersensitivity or known contraindication to

1. Dipyridamole

2. Other ultrasound contrast agents

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

3. Use of caffeine or xanthine containing products within the 24 hours prior to PB127 MPE

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

5. Atrial fibrillation

6. Permanent pacemaker or defibrillator

7. History of:

1. Complex ventricular arrhythmia

2. Chronic hepatitis

3. 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

4. Chronic obstructive pulmonary disease (COPD) that, in the opinion of the Investigator, was significant enough to contraindicate dipyridamole

5. Bronchospastic airway disease that, in the opinion of the Investigator, was significant enough to contraindicate dipyridamole

6. Coronary artery bypass graft (CABG) within the 7 days prior to Study Day 1

7. Heart transplant

8. Q wave myocardial infarction within the 7 days prior to Study Day 1

9. Cardiac intervention or surgery within the 7 days prior to Study Day 1

8. Hypertension (systolic blood pressure [SBP] >200 mmHg and diastolic blood pressure [DBP] >110 mmHg)

9. Hypotension (SBP <90 mmHg) documented within the 24 hours prior to Study Day 1

10. Significant valvular disease

1. Severe aortic stenosis (>100 mmHg peak transvalvar gradient or <0.6 cm2 estimated valve area)

2. Severe mitral regurgitation (usual clinical criteria plus or minus any of the following: proximal isovelocity surface area [PISA] >1 cm2, forward transmitral gradient of >2 m/sec, unexplained systolic flow reversal or blunting in the pulmonary veins)

3. Severe mitral stenosis (<1.0 cm2 estimated valve area)

11. Congestive heart failure (New York Heart Association [NYHA] Class IV); NYHA classes are defined in Appendix D of the protocol (see Appendix 16.1.1)

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

13. Resting oxygen saturation of < 90%

14. Pulmonary hypertension characterized by estimated pulmonary artery systolic pressure of >50 mmHg by echo or catheter criteria on Study Day 1

15. Unstable angina, Canadian Cardiovascular Society (CCS) Class IV severity, with ongoing symptoms and/or ongoing infusion of intravenous nitroglycerin; CCS grading criteria are provided in Appendix E of the protocol (see Appendix 16.1.1)

16. Second degree heart block or greater

17. Use of intravenous or intracoronary contrast agent within the 24 hours prior to Study Day 1

18. Medical conditions or other circumstances that would significantly decrease the chances of obtaining reliable data or achieving the study objectives, ie, drug dependence, psychiatric disorder, dementia, or other reasons for expected poor compliance with the Investigator's instructions; medical conditions, associated illness, or extenuating circumstances that made it unlikely that a patient can complete the clinical trial or follow-up evaluations

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
0.175 mg/kg diluted in 150 mL 5% Dextrose for Injection in glass bottles, to be administered as a single continuous infusion during image acquisition. Infusion time not to exceed 60 minutes

Locations

Country	Name	City	State
United States	Androscoggin Cardiovascular Associates	Auburn	Maine
United States	Austin Heart	Austin	Texas
United States	New England Medical Center	Boston	Massachusetts
United States	University of Virginia Health System	Charlottesville	Virginia
United States	University of Chicago Medical Center	Chicago	Illinois
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	MidWest Cardiologist Research	Columbus	Ohio
United States	Dallas VA Medical Center	Dallas	Texas
United States	Presbyterian Hospital of Dallas	Dallas	Texas
United States	Endovascular Research, LLC	Eugene	Oregon
United States	Methodist DeBakery Heart Center Cardiovascular Imaging Institute	Houston	Texas
United States	Krannert Institute of Cardiology	Indianapolis	Indiana
United States	Cardiovascular Consultants	Kansas City	Missouri
United States	Long Beach VA Medical Center Cardiology Division	Long Beach	California
United States	Mount Sinai Hospital	New York	New York
United States	Michael Morgan, MD	Phoenix	Arizona
United States	University of Pittsburgh Cardiovascular Institute	Pittsburgh	Pennsylvania
United States	Oregon Health Sciences University	Portland	Oregon
United States	University of Texas Health Sciences Center at San Antonio	San Antonio	Texas
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	University of California San Francisco	San Francisco	California
United States	Heartcare, P.C.	Scottsdale	Arizona
United States	Mayo Clinic Scottsdale	Scottsdale	Arizona
United States	Harborview Medical Center Department of Cardiology	Seattle	Washington
United States	Virginia Mason Medical Center	Seattle	Washington
United States	The Center for Cardiovascular Studies Kramer and Crouse Cardiology	Shawnee Mission	Kansas
United States	Maine Cardiology Associates	South Portland	Maine
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	Washington University School of Medicine	St. Louis	Missouri
United States	Stanford University Medical Center	Stanford	California
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	Technical adequacy and diagnostic quality of PB127 images		24 hours	No
Secondary	Compliance with image acquisition and Pb127 administration procedures		24 hours	No