CAD MedDRA version: 9.1 Level: HLT Classification code 10011085 Term: Ischaemic coronary artery disorders
Conditions
Interventions
Trade Name: IOMERON 400
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Iomeprol
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 65.32-
Trade Name: VISI
Sponsors
BRACCO IMAGING
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: Has a history of hypersensitivity to iodinated contrast agents; Has known or suspected hyperthyroidism or pheochromocytoma; Has renal impairment (eGFR 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): the mean contrast density (in Hounsfield units, [HU]) measured in the left main coronary artery (LM) and the proximal right coronary artery (RCA) will be calculated;Main Objective: To quantitatively compare the contrast enhancement in dual-source CTA of the coronary arteries, in subjects suspected of coronary artery disease (CAD), provided by Iomeron- 400 and Visipaque 320 at equally injected total volumes and flow rates. For this comparison, the mean contrast density (in Hounsfield units, [HU]) measured in the left main coronary artery (LM) and the proximal right coronary artery (RCA) will be calculated.;Secondary Objective: To compare between the Iomeron-400 and Visipaque-320 injection protocols in terms of: Diagnostic quality: -Mean contrast density (HU) in the left ventricle and proximal aorta; -Contrast to noise ratio (CNR), which is defined as the difference between the mean contrast density in the aorta (enhancing ROI) and the mean contrast density in the adjacent mediastinal tissue (non-enhancing ROI) divided by the standard deviation HU (SD(HU) measured inside enhancing ROI (CNR = [enhancing ROI(HU) - non-enhancing ROI(HU)]/SD(HU)). -Vessel delineation (number of evaluable segments of coronary arteries, out of 17) -Qualitative evaluations of motion artefacts, vessel visualization, and diagnostic confidence of the CTA; -The impact of vessel enhancement on the efficacy of vessel autosegmentation tools (computer aided diagnosis). Heart rate -Changes in the heart rate during the scanning interval | — |
Countries
Germany, Italy
Outcome results
None listed