TerminatedPhase 2

Evaluation and Optimization of PB127 Myocardial Perfusion Echocardiography on Ultrasound Systems

Stopped: Discontinued PB127 development program for business reasons

United States40 participantsStarted 2007-09

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Normal volunteers (18 30 years old), with no history of CAD
✓. 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

✕. 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
✕. Previous exposure to PB127

What they're measuring

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

Timeframe: 24 hours

Trial details

NCT IDNCT00487903

SponsorPoint Biomedical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-03

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