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Stress Echocardiography Study With Regadenoson

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ClinicalTrials.gov Identifier: NCT00907764
Recruitment Status : Terminated (Slow enrollment)
First Posted : May 25, 2009
Last Update Posted : January 23, 2014
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

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.

Condition or disease Intervention/treatment Phase
Heart Disease Coronary Artery Disease Drug: regadenoson Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : April 2009
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Regadenoson
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Regadenoson alone Drug: regadenoson
400 ug, IV
Experimental: Regadenoson with exercise Drug: regadenoson
400 ug, IV
Experimental: Regadenoson with contrast agent Drug: regadenoson
400 ug, IV
Experimental: Regadenoson with contrast agent (perfusion) Drug: regadenoson
400 ug, IV



Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00907764


Locations
United Kingdom
Northwick Park Hospital
Harrow, United Kingdom, HA1 3UJ
Sponsors and Collaborators
Gilead Sciences
Investigators
Principal Investigator: Roxy Senior Northwick Park Hospital

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT00907764     History of Changes
Other Study ID Numbers: CVT 5127
First Posted: May 25, 2009    Key Record Dates
Last Update Posted: January 23, 2014
Last Verified: January 2014

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Regadenoson
Adenosine A2 Receptor Agonists
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs