EUCTR2004-001210-13-ATActive, not recruitingNot Applicable
MS-CTA IN PULMONARY ARTERIES FOR THE DETECTION OF PULMONARY EMBOLI AND SUBSEQUENT FOLLOW-UP MS-CTP OF THE LOWER EXTREMITY VEINS FOR THE DETECTION OF DEEP VENOUS THROMBOSIS - PULMONARY MS-CTA AND MS-CTP
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Bracco Imaging S.p.A
- Enrollment
- 80
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Are at least 40 years of age
- •2. With suspected pulmonary embolism,
- •3. Referred for a MS-CTA examination of the pulmonary arteries,
- •4. Provide written Informed Consent and are 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
- •1. patients with a history of hypersensitivity to iodine-containing compounds,
- •2. patients with severe congestive heart failure (class III and IV according to NYHA classification),
- •3. patients with a severe renal failure (serum creatinine > 2.5 mg/mL),
- •4. patients having undergone any other radiological procedure utilising x-ray contrast media during the 24 hour period preceding multislice, spiral, computed tomography,
- •5. Is a pregnant or lactating female. Exclude the possibility of pregnancy:
- •-by testing on site at the institution (serum or urine ßHCG) within 1 hour prior to the start of study agent administration
- •-by questioning the patient
- •-by history (e.g., tubal ligation or hysterectomy)
- •-post-menopausal with a minimum 1 year without menses.
- •6. Has received an investigational compound within 30 days before admission into this study,
- •7. 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,
- •8. Is determined by clinical physician and/or the Investigator that the subject is clinically unsuitable for the study,
Investigators
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