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 - SonoVue MCE vs SPECT in CAD detectio

Conditions: coronary artery disease (CAD)
MedDRA version: 9.1Level: HLTClassification code 10011085Term: Ischaemic coronary artery disorders

Registration Number: EUCTR2007-003492-39-IT

Lead Sponsor: BRACCO IMAGING

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 597

Inclusion Criteria

Both sex
. Having at least 18 years of age. Having a known or suspected coronary artery disease (CAD) indicated for stress ECG-gated SPECT and coronary angiography to clarify whether they have a clinical significant coronary stenosis (≥70%). Having provided written Informed Consent and willing to comply with protocol requirements.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Has any clinically unstable cardiac condition prior to SonoVue administration such as: evolving or ongoing myocardial infarction, history of acute myocardial infarction or PCI within the previous 3 months,worsening of typical angina at rest within the previous 7 days,significant worsening of cardiac symptoms within the previous 7 days,recent coronary artery intervention or other factors suggesting clinical instability, acute cardiac failure, class III/IV cardiac failure,severe cardiac rhythm disorders. Has any contra-indications to dipyridamole or aminophylline according to each agent?s package insert. Has any known allergy to one or more of the ingredients of the investigational product. Has a previous Coronary Artery By-pass. Has any revascularization procedure or change of clinical status that may warrant a change in their status of CAD among the clinical testing under evaluation (coronary angiography, MCE or ECG-GATED SPECT). Has used methylated xanthines, phosphodiesterase inhibitor drugs such as aminophylline or dipyridamole within 24 hours prior SonoVue enhanced echocardiography or SPECT. Has not visualization of left ventricle at basal echocardiography. Has received an investigational compound within 30 days before admission into this study. Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post dose follow-up examinations. Is determined by the Investigator that the subject is clinically unsuitable for the study. Is a pregnant or lactating female.