Clinical trial NCT00594698: Familiarization and Safety Study of PB127 Ultrasound Contrast Agent
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Coronary Artery Disease
Keywords: Perfusion
Echocardiography
Cardiac angiography
SPECT
Lead sponsor: Point Biomedical
Sponsor class: INDUSTRY
First posted: 2008-01-16
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Technical adequacy and diagnostic quality of PB127 images
timeFrame: 24 hours
Secondary outcomes:
measure: Compliance with image acquisition and Pb127 administration procedures
timeFrame: 24 hours
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Michael Morgan, MD
state: Arizona
city: Scottsdale
country: United States
facility: Heartcare, P.C.
state: Arizona
city: Scottsdale
country: United States
facility: Mayo Clinic Scottsdale
state: Arizona
city: Long Beach
country: United States
facility: Long Beach VA Medical Center Cardiology Division
state: California
city: San Diego
country: United States
facility: University of California San Diego Division of Cardiology
state: California
city: San Francisco
country: United States
facility: San Francisco VA Medical Center NCIRE
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Washington
country: United States
facility: Washington Hospital Center Cardiovascular Research Institute
state: District of Columbia
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Krannert Institute of Cardiology
state: Indiana
city: Shawnee Mission
country: United States
facility: The Center for Cardiovascular Studies Kramer and Crouse Cardiology
state: Kansas
city: Auburn
country: United States
facility: Androscoggin Cardiovascular Associates
state: Maine
city: South Portland
country: United States
facility: Maine Cardiology Associates
state: Maine
city: Boston
country: United States
facility: New England Medical Center
state: Massachusetts
city: Kansas City
country: United States
facility: Cardiovascular Consultants
state: Missouri
city: St. Louis
country: United States
facility: St. Louis University Medical Center
state: Missouri
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: MidWest Cardiologist Research
state: Ohio
city: Eugene
country: United States
facility: Endovascular Research, LLC
state: Oregon
city: Portland
country: United States
facility: Oregon Health Sciences University
state: Oregon
city: Pittsburgh
country: United States
facility: University of Pittsburgh Cardiovascular Institute
state: Pennsylvania
city: Austin
country: United States
facility: Austin Heart
state: Texas
city: Dallas
country: United States
facility: Dallas VA Medical Center
state: Texas
city: Dallas
country: United States
facility: Presbyterian Hospital of Dallas
state: Texas
city: Houston
country: United States
facility: Methodist DeBakery Heart Center Cardiovascular Imaging Institute
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Sciences Center at San Antonio
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Seattle
country: United States
facility: Harborview Medical Center Department of Cardiology
state: Washington
city: Spokane
country: United States
facility: Inland Cardiology
state: Washington
city: Spokane
country: United States
facility: Northwest Cardiovascular Research Institute Spokane Cardiology
state: Washington
Study officials:
affiliation: POINT Biomedical Corp.
name: Alexander Ehlgen, MD, PhD
role: STUDY_DIRECTOR
References: