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

Conditions: 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%).
MedDRA version: 9.1Level: HLTClassification code 10011085Term: Ischaemic coronary artery disorders

Registration Number: EUCTR2007-003492-39-DE

Lead Sponsor: Bracco Imaging S.p.A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 597

Inclusion Criteria

Include subjects of both sexes who fulfill all following inclusion criteria:
·Having at least 18 years of age.
·Having a known or suspected coronary artery disease (CAD) indicated for stress ECG-gated SPECT and/or 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

Exclude a subject from this study if the subject does not fulfill the inclusion criteria, or if any of the following conditions are observed:
·Has any clinically unstable cardiac condition prior to SonoVue® administration such as:
·evolving or ongoing myocardial infarction,
·a 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 (e.g., recent deterioration of ECG, laboratory or clinical findings),
·acute cardiac failure, class III/IV cardiac failure,
·severe cardiac rhythm disorders (ventricular tachycardia sustained and not sustained in combination with symptoms).
·Has any contra-indications to dipyridamole or aminophylline (e.g. hypersensitivity to xanthines) 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 (chocolate, caffeine – including coffee, tea, and cola drinks), 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. Exclude the possibility of pregnancy:
·by testing on site at the institution (serum or urine ßHCG) within 24 hours prior to the start of investigational product administration,
·by surgical history (e.g., tubal ligation or hysterectomy),
·post menopausal with a minimum 1 year without menses.