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Stress Echocardiography Study With Regadenoson

This study has been terminated.
(Slow enrollment)
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00907764
First received: May 20, 2009
Last updated: May 7, 2012
Last verified: May 2012
History of Changes
  Purpose

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 Intervention Phase
Heart Disease
Coronary Artery Disease
 Drug: regadenoson
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

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

Further study details as provided by Gilead Sciences:

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. [ Time Frame: Within 12 minutes after dosing ] [ Designated as safety issue: No ]

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. [ Time Frame: Up to day 29 after dosing ] [ Designated as safety issue: Yes ]

Enrollment: 22
Study Start Date: April 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT00907764     History of Changes
Other Study ID Numbers: CVT 5127
Study First Received: May 20, 2009
Last Updated: May 7, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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 Antagonists
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 17, 2013