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Safety and Efficacy Study of PB127 Ultrasound Contrast Agent for Diagnosis of Coronary Artery Disease (POINT II)

This study has been terminated.
(Discontinued PB127 development program for business reasons)
Sponsor:
Information provided by:
Point Biomedical
ClinicalTrials.gov Identifier:
NCT00584896
First received: December 20, 2007
Last updated: July 1, 2008
Last verified: July 2008
  Purpose

The purpose of this study is to determine if the use of PB127 with cardiac ultrasound assists in the diagnosis or exclusion of coronary artery disease.


Condition Intervention Phase
Coronary Artery Disease
Drug: PB127 for Injectable Suspension
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 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 Artery Disease II

Resource links provided by NLM:


Further study details as provided by Point Biomedical:

Primary Outcome Measures:
  • To evaluate the diagnostic performance of PB127 MPE for the detection and/or exclusion of significant obstructive coronary artery disease as defined by qualitative coronary angiography or qualifying clinical outcome [ Time Frame: 72 hours, 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To compare the diagnostic performance of PB127 MPE to SPECT for the detection and/or exclusion of significant obstructive coronary artery disease. [ Time Frame: 72 hours, 6 months ] [ Designated as safety issue: No ]
  • To assess the concordance of PB127 MPE with SPECT in the differentiation of defect type (fixed versus reversible) in patients with significant obstructive CAD. [ Time Frame: 72 hours, 6 months ] [ Designated as safety issue: No ]
  • To evaluate the diagnostic performance characteristics of PB127 MPE for identifying the location of significant obstructive CAD as defined by quantitative coronary angiography [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • To assess the change in diagnostic certainty when PB127 MPE and relevant clinical information are combined over relevant clinical information alone. [ Time Frame: 72 hours, 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: October 2007
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: PB127 for Injectable Suspension
    0.062 mg/kg continuous IV infusion (100-250 mL/hr) during echocardiography, not to exceed 60 minutes infusion, single dose.
    Other Name: CARDIOshpere®
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  1. 18 years old or older and able to provide written informed consent;
  2. All subjects must be scheduled for or have undergone SPECT within 28 days prior to or following Study Day 1
  3. Subjects with very low/low pre-test probability of coronary artery disease must consent to participate in the extension trial 127-014-A
  4. Subjects with very low/low pre-test probability of coronary artery disease must not have a current diagnosis of obstructive CAD on angiogram or prior MI
  5. Subjects with very low/low pre-test probability of coronary artery disease with a current diagnosis of obstructive CAD on angiogram or prior MI may be enrolled into Stratum 2
  6. Subjects with intermediate or high pre-test probability of coronary artery disease must be scheduled for coronary angiography within the 28 days following Study Day 1
  7. Sinus rhythm at the time of the study procedure
  8. Adequate visualization of myocardial segments
  9. Appropriate candidate for stress testing according to ACC/AHA Guidelines for Exercise Testing

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 Study Day 1
  4. Previous exposure to PB127 Ultrasound Contrast Agent
  5. Major surgery within 7 days prior to Study Day 1 (requiring general anesthesia and/or overnight stay)
  6. Heart transplant or history of CABG
  7. Known hemodynamically significant or symptomatic right-to-left shunt (including shunts that are associated with prior TIAs or strokes)
  8. Recent history of sustained ventricular tachycardia
  9. Pacemaker or defibrillator
  10. Unstable cardiac status

    1. Unstable angina grade CCS Class IV severity (any physical activity causes limiting symptoms; symptoms may be present at rest in a patient with prior exertional angina) with ongoing symptoms and/or ongoing infusion of intravenous nitroglycerin
    2. Decompensated heart failure
    3. Second-degree or greater heart block, sick sinus syndrome
    4. Frequent (>60/hour) or symptomatic ventricular ectopics at baseline
    5. Hypertension (SBP >200 and/or DBP >110 mmHg on two consecutive readings within one hour of PB127 MPE)
    6. Hypotension (SBP <90 mmHg)
    7. Severe aortic stenosis (>40 mmHg mean gradient or <0.6 cm2/m2 valve area index)
    8. Pulmonary edema within the 7 days prior to Study Day 1
    9. Resting oxygen saturation of less than 90% on room air
  11. Myocardial infarction or cerebral vascular accident / transient ischemic attack within the 28 days prior to Study Day 1
  12. Chronic Obstructive Pulmonary Disease (COPD) or bronchospastic airway disease, which in the opinion of the Investigator, is significant enough to contraindicate dipyridamole
  13. Known history of severe pulmonary hypertension characterized by estimated pulmonary artery systolic pressure of >50 mmHg
  14. Liver disease 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
    4. Current or previous hepatic viral infection (not including hepatitis A)
    5. Chronic hepatitis
  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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00584896

  Show 40 Study Locations
Sponsors and Collaborators
Point Biomedical
Investigators
Study Director: Alexander Ehlgen, MD, PhD POINT Biomedical Corp
  More Information

No publications provided

Responsible Party: Tom Ottoboni, PhD/Chief Operating Officer, POINT Biomedical Corp.
ClinicalTrials.gov Identifier: NCT00584896     History of Changes
Other Study ID Numbers: 127-014
Study First Received: December 20, 2007
Last Updated: July 1, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Point Biomedical:
heart disease
coronary artery disease
echocardiogram
ultrasound
angiogram
SPECT
chest pain
perfusion

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2014