Dose Finding Study of PB127 Ultrasound Contrast Agent in Healthy Volunteers and Patients With Coronary Artery Disease

Sponsor

Point Biomedical (Industry)

Overall Status

Completed

CT.gov ID

NCT00584818

Collaborator

(none)

205

Enrollment

Locations

Duration (Months)

12.8

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Coronary Artery Disease	Drug: PB127 for Injectable Suspension	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

205 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

A Phase 2 Dose-Finding Clinical Trial of CARDIOsphere® (PB127) in Normal Volunteers and in Patients With Known or Suspected Coronary Artery Disease

Study Start Date :

Nov 1, 2006

Actual Primary Completion Date :

Mar 1, 2008

Actual Study Completion Date :

Mar 1, 2008

Outcome Measures

Primary Outcome Measures

To identify the minimum effective dose of PB127 [24 hours]
To identify the optimal stress infusion rate of PB127 [24 hours]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Stages 1 and 2

Men and women
Ages 18 30
Normal volunteers
No history (or suspicion) of CAD

Stage 3

Men and women with known or suspected CAD
Ages 18 years and older
Scheduled for or undergone clinically indicated coronary angiography within 28 days prior to or following Study Day 1
Coronary angiography within 28 days prior to Study Day 1 and/or SPECT must have been non-interventional
Coronary angiography images available in digital format (non cine) for transmission to core laboratory
Scheduled for or undergone SPECT within 28 days prior to or following Study Day 1

Exclusion Criteria:

Unable to provide written informed consent
Women who are pregnant or lactating
Known hypersensitivity or known contraindication to:
Dipyridamole
Ultrasound contrast agents (including PB127 and excipients)
Blood, blood products, albumin, egg whites, or protein
Use of caffeine or xanthine containing products within the 24 hours prior to PB127 administration on Study Day 1 (Stages 2 and 3)
Previous exposure to PB127
Inadequate echocardiographic windows
Heart transplant
Known right to left shunt, including atrial septal defect
History of CABG
Current uncontrolled ventricular tachycardia, atrial fibrillation, atrial tachycardia, or atrial flutter
Pacemaker or defibrillator
Unstable angina grade CCS Class IV severity with ongoing symptoms and/or ongoing infusion of IV nitroglycerin
Second degree or greater heart block
Hypertension (SPB >200 and/or DBP >110 mmHg on two consecutive readings within 1 hour prior to PB127 administration)
Hypotension (SPB <90 mmHg on two consecutive readings within 1 hour prior to PB127 administration)
Severe aortic stenosis (>100 mmHg peak transvalvar gradient or <0.6 cm2 estimated valve area)
Pulmonary edema within the 7 days prior to Study Day 1
Resting oxygen saturation of less than 90%
Q wave MI or major surgery within the 7 days prior to Study Day 1
PTCA within the 28 days prior to Study Day 1
Chronic obstructive pulmonary disease or bronchospastic airway disease which, in the opinion of the Investigator, is significant enough to contraindicate dipyridamole
Known history of severe pulmonary hypertension characterized by estimated pulmonary artery systolic pressure of >50 mmHg
Liver disease, characterized by or including one or more of the following
Elevated total bilirubin > upper limit of normal
Currently elevated hepatic enzymes >3X upper limit of normal
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Long Beach VA Medical Center Cardiology Division	Long Beach	California	United States	90822
2	University of California San Diego Division of Cardiology	San Diego	California	United States	92103
3	Alfieri Cardiology	Newark	Delaware	United States	19713
4	University of Chicago Medical Center	Chicago	Illinois	United States	60637
5	Midwest Cardiology Associates	Overland Park	Kansas	United States	66209
6	The Center for Cardiovascular Studies Kramer and Crouse Cardiology	Shawnee Mission	Kansas	United States	66204
7	Androscoggin Cardiovascular Associates	Auburn	Maine	United States	04210
8	Cardiovascular Consultants	Kansas City	Missouri	United States	64111
9	St. Louis University Medical Center	St. Louis	Missouri	United States	63110
10	The Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
11	Oregon Health Sciences University	Portland	Oregon	United States	97239
12	University of Pittsburgh Cardiovascular Institute	Pittsburgh	Pennsylvania	United States	15213
13	Seton Healthcare Network Brackenridge Hospital	Austin	Texas	United States	78701
14	Austin Heart	Austin	Texas	United States	78705
15	Inland Cardiology	Spokane	Washington	United States	99204
16	Northwest Cardiovascular Research Institute Spokane Cardiology	Spokane	Washington	United States	99204