Coronary Artery Disease, Heart Disease
Conditions
Brief 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.
Interventions
DRUGregadenoson
400 ug, IV
Sponsors
Gilead Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | Within 12 minutes after dosing |
Secondary
| Measure | Time frame |
|---|---|
| Various safety data will be collected, including adverse events, heart and blood pressure levels, ECG data, clinical laboratory results, and concomitant medications. | Up to day 29 after dosing |
Countries
United Kingdom
Outcome results
None listed