Stress Echocardiography Study With Regadenoson

NCT ID: NCT00907764

Last Updated: 2014-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2010-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Disease Coronary Artery Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Regadenoson alone

Group Type EXPERIMENTAL

regadenoson

Intervention Type DRUG

400 ug, IV

Regadenoson with exercise

Group Type EXPERIMENTAL

regadenoson

Intervention Type DRUG

400 ug, IV

Regadenoson with contrast agent

Group Type EXPERIMENTAL

regadenoson

Intervention Type DRUG

400 ug, IV

Regadenoson with contrast agent (perfusion)

Group Type EXPERIMENTAL

regadenoson

Intervention Type DRUG

400 ug, IV

Interventions

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regadenoson

400 ug, IV

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gilead Sciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Roxy Senior

Role: PRINCIPAL_INVESTIGATOR

Northwick Park Hospital

Locations

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Northwick Park Hospital

Harrow, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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CVT 5127

Identifier Type: -

Identifier Source: org_study_id

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