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: 9.1 Level: HLT Classification code 10011085 Term: Ischaemic coronary artery disorders
Conditions
Interventions
Trade Name: SonoVue
Product Name: SonoVue
Product Code: BR-1
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Sulphur Hexafluoride (SF6)
CAS Number: 2551-62-4
Co
Sponsors
Bracco Imaging S.p.A.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary endpoint of the study is to obtain a sensitivity and specificity of SonoVue® enhanced ultrasound to detect significant coronary disease (coronary stenosis =70%) non inferior to SPECT in respect to reference method i.e. coronary angiography.;Main Objective: Evaluate sensitivity and specificity of myocardial perfusion qualitative analysis obtained with SonoVue® enhanced stress echocardiography in detecting/excluding significant coronary artery disease (coronary stenosis =70%) in patients with known or suspected coronary artery disease in comparison to ECG-gated SPECT (patient level analysis). The reference method (GOLD STANDARD) will be quantitative coronary angiography. The comparison is aimed to prove the non-inferiority of SonoVue® enhanced stress echocardiography with respect to ECG-gated SPECT in terms of sensitivity and specificity, where non-inferiority is defined as SeMCE - SeSPECT > - 5% for sensitivity and SpMCE - SpSPECT > - 5% for specificity. Evaluate the safety profile of SonoVue®.;Secondary Objective: The secondary objective is the ability of myocardial perfusion qualitative analysis obtained with SonoVue® enhanced stress echocardiography in detecting/excluding significant coronary artery disease (coronary stenosis =70%) at level of the three main coronary arteries (left anterior descending artery, right coronary artery and circumflex coronary artery) in patients with known or suspected coronary artery disease in comparison to ECG-GATED SPECT. Reference method (Gold standard) will be quantitative coronary angiography (by vessel analysis). | — |
Countries
Belgium, France, Germany, Greece, Italy, Netherlands, Spain, United Kingdom
Outcome results
None listed