E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
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MedDRA Classification |
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 | No |
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 and a calcium score exam 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. Exclude the possibility of pregnancy by: -Laboratory testing on-site at the testing institution (measurement of serum or urine βHCG) 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.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary objective of this study is formulated into the following hypothesis: H0: μIOM = μVIS HA: μIOM ≠ μVIS where μIOM and μVIS are the mean contrast densities with the Iomeron®-400 and VisipaqueTM 320 groups respectively. The above hypothesis will be tested for the mean contrast densities in the left main coronary artery (LM), in the proximal right coronary artery (RCA) as well as in the combined LM/RCA artery. The two-sided t-test will be used to derive the statistical significance (p-value) for the primary hypothesis testing. If any p-value of these three tests is less than 0.05, the null hypothesis will be rejected and the alternative hypothesis will be declared. The method of analysis of covariance (ANCOVA) may also be applied to neutralize the effect of other covariates.
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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 | No |
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 | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
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.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 10 |
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 | No |
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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Last protocol-defined contact of any subject enrolled in the study. |
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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 | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |