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: SUSPECTED PULMONARY EMBOLI AND/OR DEEP VENOUS THROMBOSISMedDRA code for deep venous thrombosis: version 7 LLT 0.913

• Registration Number: EUCTR2004-001210-13-AT
• Lead Sponsor: Bracco Imaging S.p.A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10-15
• Last Update Posted: 22 April 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 80

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,

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified