Stress Echocardiography Study With Regadenoson

Coronary Artery Disease Clinical Trial

Official title:

An Open-Label, Parallel-Group, Exploratory Study to Evaluate the Efficacy and Safety of 400 ug Regadenoson Bolus for Pharmacological Stress Echocardiography

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00907764
• Other study ID #: CVT 5127
• Status: Terminated
• Phase: Phase 2
• First received: May 20, 2009
• Last updated: January 22, 2014
• Start date: April 2009
• Est. completion date: April 2010

Study information

• Verified date: January 2014
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Heart Disease
• Myocardial Ischemia

Intervention

Drug:
• regadenoson
400 ug, IV

Locations

Country	Name	City	State
United Kingdom	Northwick Park Hospital	Harrow

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes