Evaluation and Optimization of PB127 Myocardial Perfusion Echocardiography on Ultrasound Systems

Healthy Clinical Trial

Official title:

A Phase 2 Trial of PB127 Myocardial Perfusion Echocardiography to Evaluate and Optimize Additional Ultrasound Imaging Systems

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00487903
• Other study ID #: 127-015
• Status: Terminated
• Phase: Phase 2
• First received: June 15, 2007
• Last updated: July 1, 2008
• Start date: September 2007
• Est. completion date: March 2008

Study information

• Verified date: July 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 clinical trial is to evaluate various commercially available ultrasound systems and to identify imaging parameters to be used with these systems (along with the contrast agent PB127) as well as to further evaluate the safety of PB127.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Men and women

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:

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

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Healthy
• Myocardial Ischemia

Intervention

Drug:
• PB127 for Injectable Suspension
0.062 mg/kg continuous IV (100-250 mL/hr) during echocardiogram, single dose, infusion not to exceed 60 minutes.

Locations

Country	Name	City	State
United States	Baylor Research Institute	Dallas	Texas
United States	Duke University Medical Center	Durham	North Carolina
United States	Midwest Cardiology Associates	Overland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Point Biomedical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of optimal machine settings and imaging parameters for myocardial perfusion for a variety of ultrasound imaging systems to be used in upcoming clinical trials		24 hours	No