Stress Echocardiography Study With Regadenoson
Information source: CV Therapeutics
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Heart Disease; Coronary Artery Disease
Intervention: regadenoson (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: CV Therapeutics Official(s) and/or principal investigator(s):
Roxy Senior, Principal Investigator, Affiliation: Northwick Park Hospital
Overall contact:
Peter Staehr, M.D., Email: peter.staehr@gilead.com
Summary
Regadenoson is approved in the US under the brand name Lexiscan for myocardial perfusion
imaging. This study will test whether regadenoson is an appropriate stress agent for stress
echocardiography.
Clinical Details
Official title: An Open-Label, Parallel-Group, Exploratory Study to Evaluate the Efficacy and Safety of 400 ug Regadenoson Bolus for Pharmacological Stress Echocardiography
Study design: Diagnostic, Non-Randomized, Open Label, Parallel Assignment
Primary outcome: Cardiac wall motion and perfusion abnormalities at rest and with regadenoson stress, with regadenoson stress and low level exercise, and with regadenoson stress and an echocontrast agent.
Secondary outcome: Various safety data will be collected, including adverse events, heart and blood pressure levels, ECG data, clinical laboratory results, and concomitant medications.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients with a clinically indicated dobutamine echocardiogram showing normal wall
motion at rest and abnormal wall motion with stress
- Patients with a clinically indicated dipyridamole echocardiogram showing normal
perfusion and wall motion at rest and abnormal perfusion with or without abnormal
wall motion with stress
Exclusion Criteria:
- Any condition precluding the safe administration of dobutamine, dipyridamole or
SonoVue for echocardiography
- Pregnant or breast-feeding, or (if pre-menopausal), not practicing acceptable method
of birth control
Locations and Contacts
Peter Staehr, M.D., Email: peter.staehr@gilead.com
Northwick Park Hospital, Harrow HA1 3UJ, United Kingdom; Recruiting
Reinette Hampson, Phone: 011 0208 869 2547
Additional Information
Starting date: April 2009
Ending date: April 2010
Last updated: October 1, 2009
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