BR1-142 Lumason/SonoVue in Stress Echocardiography
Research type
Research Study
Full title
A Prospective Multicenter Phase III Clinical Evaluation of the Safety and Efficacy of Lumason/SonoVue in Subjects Undergoing Pharmacologic Stress Echocardiography with Dobutamine for the Diagnosis of Coronary Artery Disease
IRAS ID
190759
Contact name
Alberto Spinazzi
Contact email
Sponsor organisation
Bracco Imaging S.p.A.
Eudract number
2015-001962-25
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
IND No. , 46958
Duration of Study in the UK
1 years, 4 months, 31 days
Research summary
Ultrasound is a diagnostic imaging test that uses sound waves to make pictures of the body without using ionizing radiation (X-rays).
It is widely used to diagnose many diseases in the body.An ultrasound of the heart is called an echocardiogram(echo).
An echocardiogram is a non-invasive procedure used to show the heart’s function and structures.
SonoVue has been developed for use as a contrast agent to make the images created using ultrasound equipment clearer to see and understand.
It is a liquid that contains small bubbles of sulfur hexafluoride, which dissolve in the blood and are exhaled.In addition to evaluating the heart at rest,this ultrasound contrast agent can help improve the ability to see the borders of the heart during an examination at stress.
Stress to the heart can be obtained by physical exercise or the use of certain medications.
There is some disadvantage to using physical exercise to perform a stress study like this because it is often difficult to monitor the changes in the heart closely and the imaging results could be unreliable if the patient is breathing too fast.
Dobutamine is the pharmacologic medication that will be used during the stress portion of this study.
A second medication,Atropine,may also be administered during ultrasound examination if needed.
Both of these medications are on the market and are often administered during stress echocardiography.SonoVue® is approved for use in rest and stress ultrasound examinations in Europe,Canada,China,Korea and India.
However,it is currently approved in the US (tradename Lumason) for imaging the heart at rest,but not at stress.This study is one of two studies being performed to collect information and try to obtain approval for its use in the US for the stress ultrasound examination of the heart.
The study will involve approximately 175 subjects across about 10-15 investigational sites in the United States,Canada and Europe.REC name
London - Harrow Research Ethics Committee
REC reference
16/LO/0014
Date of REC Opinion
4 Mar 2016
REC opinion
Further Information Favourable Opinion