Clinical trial NCT00595244: Safety and Efficacy Study of PB127 Ultrasound Contrast Agent in Patients With Suspected Coronary Artery Disease
Official title: CSP 127-006 A Phase 3 Clinical Trial to Assess Perfusion and Obstruction Identified by Non-Invasive Technology Using PB127 Ultrasound Contrast Agent in Patients With Suspected Obstructive Coronary Arter Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Artery Disease
Keywords: Perfusion
Echocardiograpy
SPECT
angiography
Chest pain
Lead sponsor: Point Biomedical
Sponsor class: INDUSTRY
First posted: 2008-01-16
Enrollment: 456
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: This trial is to compare PB127 echocardiography to other heart imaging studies.


Eligibility criteria: Inclusion Criteria:

Stratum 1:

1. Able to provide written informed consent
2. Low (less than 10%) pre-test probability of CAD (Appendix D)
3. Scheduled for clinically indicated stress echocardiography or stress SPECT within the 14 days prior to or following Study Day 1 (prior to coronary angiography) or coronary angiography within the 7 days following Study Day 1
4. Technically adequate unreconstructed stress SPECT data or scheduled for clinically indicated stress SPECT within 14 days of Study Day 1 and prior to coronary angiography
5. Adequate visualization of all myocardial segments in at least one view during non-contrast echocardiography (See Section 5.3.1)
6. No evidence of a right-to-left shunt during non-contrast echocardiography

Stratum 2:

1. Able to provide written informed consent
2. Intermediate (10% to 90%) pre-test probability of CAD (Appendix D)
3. Scheduled for clinically indicated coronary angiography within the 7 days following Study Day 1
4. Technically adequate unreconstructed stress SPECT data or scheduled for stress SPECT within 14 days of Study Day 1 and prior to coronary angiography
5. Adequate visualization of all myocardial segments in at least one view during non-contrast echocardiography (See Section 5.3.1)
6. No evidence of a right-to-left shunt during non-contrast echocardiography

Stratum 3:

1. Able to provide written informed consent
2. High (greater than 90%) pre-test probability of CAD (Appendix D)
3. Scheduled for clinically indicated coronary angiography within the 7 days following Study Day 1
4. Technically adequate unreconstructed stress SPECT data or scheduled for stress SPECT within 14 days of Study Day 1 and prior to coronary angiography
5. Adequate visualization of all myocardial segments in at least one view during non-contrast echocardiography (See Section 5.3.1)
6. No evidence of a right-to-left shunt during non-contrast echocardiography

Exclusion Criteria:

1. Women who are pregnant or lactating
2. Known hypersensitivity or known contraindication to:

   1. Dipyridamole
   2. Ultrasound contrast agents (including PB127 and excipients)
   3. Blood, blood products, albumin, egg, or protein
3. Use of caffeine or xanthine containing products within the 24 hours prior to PB127 MCE
4. Previous exposure to PB127 Ultrasound Contrast Agent
5. Heart transplant
6. Known right-to-left shunt including atrial septal defect
7. Current or history of uncontrolled ventricular tachycardia
8. Current atrial fibrillation, atrial tachycardia, or atrial flutter
9. Pacemaker or defibrillator
10. Unstable cardiac status

    1. Unstable angina grade CCS Class IV severity with ongoing symptoms and/or ongoing infusion of intravenous nitroglycerin (See Appendix F)
    2. Second-degree or greater heart block
    3. Frequent (\>60/hour) or symptomatic ventricular ectopics at baseline
    4. Hypertension (SPB \>200 and/or DBP \>110 mmHg on two consecutive readings within one hour of PB127 MCE)
    5. Hypotension (SPB \<90 mmHg)
    6. Severe aortic stenosis (\>100 mmHg peak transvalvar gradient or \<0.6 cm2 estimated valve area)
    7. Pulmonary edema within the 7 days prior to Study Day 1
    8. Resting oxygen saturation of less than 90%
    9. Q-wave myocardial infarction within the 7 days prior to Study Day 1
    10. PTCA or CABG within the 7 days prior to Study Day 1
11. Chronic Obstructive Pulmonary Disease (COPD) or bronchospastic airway disease which, in the opinion of the Investigator, is significant enough to contraindicate dipyridamole
12. Known history of severe pulmonary hypertension characterized by estimated pulmonary artery systolic pressure of \>50 mmHg
13. Use of intravenous or intracoronary contrast agent other than thallium or technetium within the 24 hours prior to Study Day 1
14. Liver disease (i.e., current or previous hepatic viral infection, chronic hepatitis) characterized by one or more of the following

    1. Current jaundice
    2. Elevated bilirubin \> upper limit of normal
    3. Currently elevated hepatic enzymes \> 2X upper limit of normal
15. 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, 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 Investigator's instructions

Primary outcomes:
measure: To demonstrate the non-inferiority of the diagnostic performance of PB127 MCE versus stress SPECT in the detection and/or exclusion of significant obstructive CAD as defined by QCA or qualifying clinical outcome.
timeFrame: 90 days
Secondary outcomes:
measure: To assess the concordance of PB127 MCE with stress SPECT in differentiating between reversible vs. fixed defects in patients with significant obstructive CAD
timeFrame: 28 days
measure: To compare the diagnostic performance of PB127 MCE with stress SPECT in identifying the location of stenosis as identified by coronary angiography.
timeFrame: 28 days
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Michael Morgan, MD
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: Washington
country: United States
facility: Washington Hospital Center Cardiovascular Research Institute
state: District of Columbia
city: Shawnee Mission
country: United States
facility: The Center for Cardiovascular Studies Kramer & Crouse Cardiology
state: Kansas
city: Boston
country: United States
facility: New England Medical Center
state: Massachusetts
city: St. Louis
country: United States
facility: St. Louis University Medical Center
state: Missouri
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation Department of Cardiology
state: Ohio
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: San Antonio
country: United States
facility: University of Texas Health Sciences Center at San Antonio
state: Texas
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: Northwest Cardiovascular Research Institute Spokane Cardiology
state: Washington
Study officials:
affiliation: POINT Biomedical Corp.
name: Alexander Ehlgen, MD, PhD
role: STUDY_DIRECTOR
References: