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 the patient has clinically significant stenesosis (>70%).MedDRA version: 9.1 Level: HLT Classification code 10011085 Term: Ischaemic coronary artery disorders
- Registration Number
- EUCTR2007-003492-39-GB
- Lead Sponsor
- Bracco Research S.P.A
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 597
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 ECGgated 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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method