Patients with suspected coronary artery disease and clinically referred for coronary CTA.
Conditions
Interventions
Trade Name: Visipaque
Product Name: Visipaque
Pharmaceutical Form: Concentrate and solvent for solution for injection/infusion
Trade Name: Ultravist
Product Name: Ultravist 300
Pharmaceutical Form: C
Sponsors
ErasmusMC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age >18 yrs • Body weight 50 – 125 kg 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 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: • Pregnancy • Renal dysfunction defined as eGFR<45 ml/min • Allergies to iodine contrast media, manifest thyreotoxicosis • Arrhythmia, including atrial fibrillation/flutter, 2nd or 3rd degree AV block, frequent ectopic beats prior to the exam (discretion of the referrer). • Prior coronary artery bypass graft surgery or coronary stents • Contraindications to the contrast media according to SPC (summary of product characteristics)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Demonstrate that with contemporary cardiac CT scan protocols good opacification of the coronary arteries can be achieved, that is similar to low-osmolar contrast media injected at the same iodine delivery rate.;Secondary Objective: investigate the effect of iso-osmolar contrast media on heart rate and variability in relation to image quality.;Primary end point(s): Intra-coronary opacification: i.e. the mid-coronary lumen attenuation expressed in Hounsfield Units (HU), primary endpoint, demonstrating non-inferiority. Mean attenuation measured in the mid LAD (7), proximal LCX (11) and mid RCA (2), averaged per patient. Requirements: •Vessel: minimal diameter 2 mm, good or moderate image quality. •ROI size: circular shape, minimum 50 pixels per sample. •ROI placement: axial images, center of the vessel, optimal image quality, ;Timepoint(s) of evaluation of this end point: After the last included patient' scan is performed | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Quantitative and qualitative image quality • Differential contrast attenuation: proximal, mid, distal coronary arteries. • Signal to noise (attenuation versus SD) and contrast to noise ratios (difference between coronary and myocardium versus myocardium). • Subjective image quality of the coronary arteries on a 3-point scale: good, diagnostic, poor. • Image artifacts, categorized per segment • Contrast plateau characteristics: enhancement throughout the vasculature from systemic venous system to the descending aorta and myocardium. Cardiovascular effects • Heart rate before scan (mean over 15s); during calcium score (mean over heart cycles during scan); during CTA (mean over heart cycles during scan). • Number of ectopic beats throughout the ECG recording during and after contrast injection. • Heart rate variability (variance to the mean RR duration) • Occurrence of atrial fibrillation. Contrast injection parameters • Injection characteristics: accomplished flow rates, resistance, etc. • Clinical effect: patient discomfort at the injection site and adverse events, contrast reactions, nausea, etc. • Contrast delivery parameters (Certega box): • Injection rate and pressure Clinical safety • Contrast extravasation (binary). • Severe arrhythmia, with hemodynamical significance. • Allergic reactions • Renal failure ;Timepoint(s) of evaluation of this end point: After the last included patient' scan is performed | — |
Countries
Netherlands
Contacts
Public Contacttrial coordinator
ErasmusMC
Outcome results
None listed