NCT00907764

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 25, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

January 23, 2014

Status Verified

January 1, 2014

Enrollment Period

1 year

First QC Date

May 20, 2009

Last Update Submit

January 22, 2014

Conditions

Heart DiseaseCoronary Artery Disease

Outcome Measures

Primary Outcomes (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 Outcomes (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

Study Arms (4)

Regadenoson alone

EXPERIMENTAL
Drug: regadenoson

Regadenoson with exercise

EXPERIMENTAL
Drug: regadenoson

Regadenoson with contrast agent

EXPERIMENTAL
Drug: regadenoson

Regadenoson with contrast agent (perfusion)

EXPERIMENTAL
Drug: regadenoson

Interventions

regadenosonDRUG

400 ug, IV

Regadenoson aloneRegadenoson with contrast agentRegadenoson with contrast agent (perfusion)Regadenoson with exercise

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwick Park Hospital

Harrow, HA1 3UJ, United Kingdom

Location

MeSH Terms

Conditions

Heart DiseasesCoronary Artery Disease

Interventions

regadenoson

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesCoronary DiseaseMyocardial IschemiaArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Roxy Senior

    Northwick Park Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2009

First Posted

May 25, 2009

Study Start

April 1, 2009

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

January 23, 2014

Record last verified: 2014-01

Locations

GB(1)