Studio randomizzato di fase IV, doppio cieco, multicentrico, per il confronto di Iomeron 400 con Visipaque 320 nell'angiografia coronarica con Tomografia Computerizzata a doppio tubo (DS-CTA) - Coronary Dual Source CTA

Active, not recruiting

• Conditions: CAD; MedDRA version: 9.1Level: HLTClassification code 10011085Term: Ischaemic coronary artery disorders

• Registration Number: EUCTR2007-003197-26-IT
• Lead Sponsor: BRACCO IMAGING

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01-14
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

Can provide written informed consent and are willing to comply with protocol requirements; Is at least 18 years of age; Weighs less than 150 kg; Is scheduled for Computed Tomography due to suspicion of CAD.
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

Has a history of hypersensitivity to iodinated contrast agents; Has known or suspected hyperthyroidism or pheochromocytoma; Has renal impairment (eGFR <60 mL/min/1.73 m2 [using the abbreviated MDRD formula] or SCr >1.5 mg/dL); Has atrial fibrillation or any other cardiac rhythm that precludes reliable ECG triggering; Has severe congestive heart failure, New York Heart Classification (NYHA) Class IV; Is a pregnant or lactating female. Was previously entered into this study; Has received an investigational compound within 30 days before the admission into the study; Has received an iodinated contrast agent within 7 days prior to administration of Investigational Product (IP) or is scheduled to receive within 2 hours after IP administration (for the definition of IP, see section 6) other than for a related coronary angiography procedure; Is institutionalized by law; Is determined by the Investigator to be clinically unsuitable for the study; Has peripheral vein conditions that would not allow for the required fast administration of contrast agents (18 gauge needle); 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.

Study & Design

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