Back to resultsStress Echocardiography Study With Regadenoson
Primary Purpose
Heart Disease, Coronary Artery Disease
Status
Terminated
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
regadenoson
Sponsored by
About this trial
This is an interventional diagnostic trial for Heart Disease
Eligibility 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
Sites / Locations
- Northwick Park Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Regadenoson alone
Regadenoson with exercise
Regadenoson with contrast agent
Regadenoson with contrast agent (perfusion)
Arm Description
Outcomes
Primary Outcome Measures
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 Measures
Various safety data will be collected, including adverse events, heart and blood pressure levels, ECG data, clinical laboratory results, and concomitant medications.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00907764
Brief Title
Stress Echocardiography Study With Regadenoson
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 Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Terminated
Why Stopped
Slow enrollment
Study Start Date
April 2009 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Disease, Coronary Artery Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Regadenoson alone
Arm Type
Experimental
Arm Title
Regadenoson with exercise
Arm Type
Experimental
Arm Title
Regadenoson with contrast agent
Arm Type
Experimental
Arm Title
Regadenoson with contrast agent (perfusion)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
regadenoson
Intervention Description
400 ug, IV
Primary Outcome Measure Information:
Title
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.
Time Frame
Within 12 minutes after dosing
Secondary Outcome Measure Information:
Title
Various safety data will be collected, including adverse events, heart and blood pressure levels, ECG data, clinical laboratory results, and concomitant medications.
Time Frame
Up to day 29 after dosing
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roxy Senior
Organizational Affiliation
Northwick Park Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwick Park Hospital
City
Harrow
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom
12. IPD Sharing Statement
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Stress Echocardiography Study With Regadenoson
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