see separate synopsis
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
see separate synopsis
Secondary outcome
see separate synopsis
Background summary
see separate synopsis
Study objective
see separate synopsis
Study design
see separate synopsis
Intervention
see separate synopsis
Study burden and risks
see separate synopsis
Via Folli 50
I-20134 Milaan
Italie
Via Folli 50
I-20134 Milaan
Italie
Listed location countries
Age
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.
Exclusion criteria
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 *HCG) 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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
EudraCT | EUCTR2007-003492-39-NL |
CCMO | NL20857.029.08 |