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

  • United Kingdom
      • 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
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

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

Gilead Sciences

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

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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