Stress Echocardiography Study With Regadenoson

• Sponsor: Gilead Sciences (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00907764
• Collaborator: (none)
• Enrollment: 22
• Location: 1
• Arms: 4
• Duration (Months): 12
• Patients Per Site Per Month: 1.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Disease; Coronary Artery Disease	Drug: regadenoson	Phase 2

Study Design

• Study Type: Interventional
• 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: Apr 1, 2009
• Actual Primary Completion Date: Apr 1, 2010
• Actual Study Completion Date: Apr 1, 2010

Arms and Interventions

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

Outcome Measures

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. [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. [Up to day 29 after dosing]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwick Park Hospital	Harrow		United Kingdom	HA1 3UJ

Sponsors and Collaborators

• Gilead Sciences

Investigators

• Principal Investigator: Roxy Senior, Northwick Park Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gilead Sciences
• ClinicalTrials.gov Identifier: NCT00907764
• Other Study ID Numbers: CVT 5127
• First Posted: May 25, 2009
• Last Update Posted: Jan 23, 2014
• Last Verified: Jan 1, 2014

• Additional relevant MeSH terms: Coronary Artery Disease; Heart Diseases; Regadenoson

Study Results

No Results Posted as of Jan 23, 2014