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. In addition, we will investigate the…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Demonstrate comparable coronary opacification by iodixanol 270 (iso-osmolar
contrast medium) in comparison to iopromide 300 (low-osmolar contrast medium),
when injected with a comparable iodine flux.
Secondary outcome
Investigate additional differences between iodixanol and iopromide, in terms
of:
• Effect on heart rate, heart rate variability and arrhythmia
• Venous contrast congestion (accumulation)
• Qualitative and quantitative image quality
• Patient discomfort and adverse events during and after injection
Background summary
Non-invasive imaging of the coronary arteries to identify atherosclerotic
disease and narrowing has over the past decade gained widespread acceptance in
the diagnostic workup of suspected CAD [Montalescot 2013]. Different contrast
media are available to opacify the coronary lumen. The contrast media vary in
terms of iodine concentration and osmolality. Until recently the goal in
coronary CT was to achieve high opacification to compensate for other
limitations of CT, favouring high-concentration contrast media or high
injection rates with lower concentrations.
However, cardiac CT has continued to evolve. Apart from improving image
quality, much attention has been paid to the reduction of radiation exposure.
Contemporary cardiac CT involves axial scan modes (as opposed to spiral modes),
very short scan times, lower tube potentials, iterative reconstruction
algorithms. These innovation warrant a critical look at what we expect or
demand from our contrast media. The contrast medium and protocol we use should
support our aim for high diagnostic quality, while minimizing the overall
amount of contrast medium.
Study 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. In addition, we will
investigate the effect of iso-osmolar contrast media on heart rate and
variability in relation to image quality.
Study design
Double-blinded, randomized diagnostic validation trial
Study burden and risks
Both contrast media are approved and have been clinically used worldwide for
many years. There are no additional risk for the participating patient.
's Gravendijkwal 230
Rotterdam 3015CE
NL
's Gravendijkwal 230
Rotterdam 3015CE
NL
Listed location countries
Age
Inclusion criteria
Age >18 yrs
• Body weight 50 - 125 kg
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2014-000681-22-NL |
| CCMO | NL46493.078.14 |