Evaluation and Optimization of PB127 Myocardial Perfusion Echocardiography on Ultrasound Systems
NCT ID: NCT00487903
Last Updated: 2008-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
40 participants
INTERVENTIONAL
2007-09-30
2008-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Interventions
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PB127 for Injectable Suspension
0.062 mg/kg continuous IV (100-250 mL/hr) during echocardiogram, single dose, infusion not to exceed 60 minutes.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Normal volunteers (18 30 years old), with no history of CAD
2. Patients (≥ 18 years old) with known or suspected CAD, scheduled for or undergone clinically indicated coronary angiography within 28 days prior to or following Study Day 1
Exclusion Criteria
2. Women who are pregnant or lactating
3. Known hypersensitivity or known contraindication to:
1. Dipyridamole
2. Ultrasound contrast agents (including PB127 and excipients)
3. Blood, blood products, albumin, egg whites, or protein
4. Use of caffeine or xanthine containing products within the 24 hours prior to PB127 administration on Study Day 1
5. Previous exposure to PB127
6. Inadequate echocardiographic windows
7. Heart transplant
8. Known right to left shunt, including atrial septal defect
9. History of CABG
10. Current uncontrolled ventricular tachycardia, atrial fibrillation, atrial tachycardia, or atrial flutter
11. Pacemaker or defibrillator
12. Unstable angina grade CCS Class IV severity with ongoing symptoms and/or ongoing infusion of IV nitroglycerin
13. Second degree or greater heart block
14. Hypertension (SPB \>200 and/or DBP \>110 mmHg on two consecutive readings within 1 hour prior to PB127 administration)
15. Hypotension (SPB \<90 mmHg on two consecutive readings within 1 hour prior to PB127 administration)
16. Severe aortic stenosis (\>100 mmHg peak transvalvar gradient or \<0.6 cm2 estimated valve area)
17. Pulmonary edema within the 7 days prior to Study Day 1
18. Resting oxygen saturation of less than 90%
19. Q wave MI within the 7 days prior to Study Day 1
20. PTCA within the 28 days prior to Study Day 1
21. Chronic obstructive pulmonary disease or bronchospastic airway disease which, in the opinion of the Investigator, is significant enough to contraindicate dipyridamole
22. Known history of severe pulmonary hypertension characterized by estimated pulmonary artery systolic pressure of \>50 mmHg
23. Liver disease, characterized by or including one or more of the following
1. Elevated total bilirubin \>upper limit of normal
2. Currently elevated hepatic enzymes \>3X upper limit of normal
24. 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
18 Years
ALL
Yes
Sponsors
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Point Biomedical
INDUSTRY
Responsible Party
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Point Biomedical Corp.
Principal Investigators
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Alexander Ehlgen, MD, PhD
Role: STUDY_DIRECTOR
POINT Biomedical Corp.
Locations
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Midwest Cardiology Associates
Overland Park, Kansas, United States
Duke University Medical Center
Durham, North Carolina, United States
Baylor Research Institute
Dallas, Texas, United States
Countries
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Other Identifiers
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127-015
Identifier Type: -
Identifier Source: org_study_id