BR1-125, study to compare SonoVue® enhanced MCE to ECG-Gated SPECT

• Research type

  Research Study

• Full title

  A phase III study to compare SonoVue® enhanced myocardial echocardiography (MCE) to single photon emission computerized tomography (ECG-GATED SPECT), at rest and at peak of low-dose Dipyridamole stress test, in the assessment of significant coronary artery disease (CAD) in patients with suspect or known CAD using Coronary Angiography as Gold Standard

• Contact name

  Roxy Senior

• Sponsor organisation

  Bracco imaging S.p.A

• Eudract number

  2007-003492-39

• ISRCTN Number

  IRAS

• Research summary

  Echocardiography is a routine, very safe and widely used diagnostic procedure based on the use of ultrasound to visualize and examine the contraction (thickening) of the heart muscle. In the presence of coronary artery disease the contraction of the heart muscle is generally reduced, particular during cardiac stress which can be achieved either through exercise or by using certain drugs (eg dipyridamole). The use of a contrast agent allows a better visualization of the heart muscle movement and can also allow the evaluation of the blood vessels which bring blood to the heart muscle at rest and with cardiac stress and is known as myocardial contrast echocardiography (MCE). The main purpose of this study is to compare MCE enhanced by the contrast agent SonoVue© to another diagnostic procedure, cardiac scintigraphy (also known as a ??nuclear heart scan? or SPECT), in the evaluation of the presence or absence of significant Coronary Artery Disease (CAD). The two methods will be compared to a third one, coronary angiography, which is currently considered as the reference or ??Gold Standard? method. MCE is a relatively new technique used to diagnose CAD. Cardiac scinitgraphy is used more routinely at present for this purpose. The purpose of this comparison is to determine whether Sonovue enhanced MCE is as accurate as cardiac scintigraphy in detecting or excluding significant CAD. Eligible subjects have a known or suspected CAD indicated for stress ECG-gated SPECT and/or coronary angiography to clarify whether they have a clinical significant coronary stenosis (= 70%). Each subject will undergo stress MCE, stress SPECT and coronary angiography.The trial procedure (MCE) will be completed in about 2 hours.The study is also being conducted to evaluate the safety profile of SonoVue© and will involve approximately 600 patients across about 30 European investigational sites.

• REC name

  London - Central Research Ethics Committee

• REC reference

  08/H0718/59

• Date of REC Opinion

  3 Oct 2008

• REC opinion

  Further Information Favourable Opinion