A PHASE IV RANDOMIZED, DOUBLE-BLIND, MULTICENTER STUDY FOR THE COMPARISON OF IOMERON®-400 VS VISIPAQUE™ 320 IN CORONARY DUAL-SOURCE COMPUTED TOMOGRAPHIC ANGIOGRAPHY (DS-CTA)
- Conditions
- The primary aim of this study is to quantitatively compare the arterial contrast enhancement (HU) in coronary CTA after injection of either Iomeron®-400 or Visipaque™ 320. Approximately 96 subjects, suspected of having coronary artery disease, who are scheduled to undergo coronary CTA examination on a dual-source CT scanner will be enrolled in this study.
- Registration Number
- EUCTR2007-003197-26-DE
- Lead Sponsor
- Bracco Imaging S.p.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 96
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 and a calcium score exam 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
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. Exclude the possibility of pregnancy by:
-Laboratory testing on-site at the testing institution (measurement of serum or urine ßHCG) within 24 hours prior to IP administration;
-History (e.g., tubal ligation, hysterectomy or post-menopausal with a minimum of 1 year without menses);
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 (e.g., Calcium Score that in the opinion of the investigator is too high to obtain diagnostic images), 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
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method