E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10011085 |
E.1.2 | Term | Ischaemic coronary artery disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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 |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | 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 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |