- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00907764
Stress Echocardiography Study With Regadenoson
January 22, 2014 updated by: Gilead Sciences
An Open-Label, Parallel-Group, Exploratory Study to Evaluate the Efficacy and Safety of 400 ug Regadenoson Bolus for Pharmacological Stress Echocardiography
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
22
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Harrow, United Kingdom, HA1 3UJ
- Northwick Park Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Regadenoson alone
|
400 ug, IV
|
Experimental: Regadenoson with exercise
|
400 ug, IV
|
Experimental: Regadenoson with contrast agent
|
400 ug, IV
|
Experimental: Regadenoson with contrast agent (perfusion)
|
400 ug, IV
|
What is the study measuring?
Primary Outcome Measures
Outcome 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.
Time Frame: Within 12 minutes after dosing
|
Within 12 minutes after dosing
|
Secondary Outcome Measures
Outcome 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.
Time Frame: Up to day 29 after dosing
|
Up to day 29 after dosing
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Roxy Senior, Northwick Park Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2009
Primary Completion (Actual)
April 1, 2010
Study Completion (Actual)
April 1, 2010
Study Registration Dates
First Submitted
May 20, 2009
First Submitted That Met QC Criteria
May 21, 2009
First Posted (Estimate)
May 25, 2009
Study Record Updates
Last Update Posted (Estimate)
January 23, 2014
Last Update Submitted That Met QC Criteria
January 22, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Myocardial Ischemia
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Disease
- Heart Diseases
- Coronary Artery Disease
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Purinergic Agents
- Purinergic P1 Receptor Agonists
- Purinergic Agonists
- Adenosine A2 Receptor Agonists
- Regadenoson
Other Study ID Numbers
- CVT 5127
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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