Coronary Artery Disease, Healthy
Conditions
Keywords
coronary artery disease, chest pain, healthy volunteers, SPECT, angiogram, ultrasound, echocardiogram, perfusion
Brief summary
The purpose of this study is to determine the dose of PB127 for detection and/or exclusion of coronary artery disease when used with cardiac ultrasound. This study also evaluates the safety of PB127.
Interventions
Stages 1 & 2 0.009 - 0.204 mg/kg continuous IV during rest and stress conditions. Infusion rate of 50 - 125 mL/hr will be adjusted for image quality and diagnostic quality. Infusion limited to 60 minutes or less. Stage 3 - will utilize infusion rate and dose established in Stages 1 & 2. 0.062 mg/kg continuous IV infusion at 150 mL/hr during rest and 100 mL/hr during stress conditions.
Sponsors
Point Biomedical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Stages 1 and 2 1. Men and women 2. Ages 18 30 3. Normal volunteers 4. No history (or suspicion) of CAD Stage 3 1. Men and women with known or suspected CAD 2. Ages 18 years and older 3. Scheduled for or undergone clinically indicated coronary angiography within 28 days prior to or following Study Day 1 1. Coronary angiography within 28 days prior to Study Day 1 and/or SPECT must have been non-interventional 2. Coronary angiography images available in digital format (non cine) for transmission to core laboratory 4. Scheduled for or undergone SPECT within 28 days prior to or following Study Day 1
Exclusion criteria
1. Unable to provide written informed consent 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 (Stages 2 and 3) 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 or major surgery 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To identify the minimum effective dose of PB127 | 24 hours |
| To identify the optimal stress infusion rate of PB127 | 24 hours |
Secondary
| Measure | Time frame |
|---|---|
| To assess the efficacy of PB127 MPE using the dose and stress infusion rate identified in Stages 1 and 2 | 24 hours |
| To evaluate the safety of PB127 | 24 hours |
Countries
United States
Outcome results
None listed