· Explore the relative impacts of iodine concentration versus iodine delivery rate on intra-coronary attenuation. · Describe the effect of iodine concentration on contrast bolus characteristics e.g. bolus homogeneity, time-to-peak, and pressure…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Assessment of coronary attenuation on a per-segment basis
Secondary outcome
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Background summary
Contrast protocols in CT coronary angiography are designed to achieve a high
intra-coronary attenuation because it improves both image quality and
confidence of the reader. Moreover, it has been shown that higher
intra-coronary attenuation improves the overall diagnostic accuracy of CT
coronary angiography in the detection or exclusion of significant coronary
stenoses[1]. Newly designed contrast media with higher iodine concentrations
have been introduced in past years. It has been advocated to use these high-end
contrast media in CT coronary angiography. However, it is currently unknown
whether the use of high iodine concentration contrast media is beneficial as
compared to low iodine concentrations if the iodine delivery rates (mgI/s) are
the same.
We hypothesize that the use of contrast media with different iodine
concentrations, but identical iodine delivery rates, results in a similar
intra-vascular attenuation in CT coronary angiography.
Study objective
· Explore the relative impacts of iodine concentration versus iodine delivery
rate on intra-coronary attenuation.
· Describe the effect of iodine concentration on contrast bolus characteristics
e.g. bolus homogeneity, time-to-peak, and pressure curves during contrast media
injection.
Study design
Observer-blinded, controlled, randomized trial. All subjects will undergo
clinically mandated CT coronary angiography using one of 4 standardly used scan
protocols: Contrast media with different iodine concentrations will be
delivered at a normalized iodine delivery rate (2.0 mgI/s).
Study burden and risks
All the protocols normally yield results sufficient for clinical use, and none
of the protocols is associated with a heightened risk of adverse effects.
Participation in this study will not cause any delay in the CT coronary
angiography procedure. Thus, other than the randomization, the subject should
not undergo any burden or risk from participation in this study.
's Gravendijkwal 230
3015 CE
NL
's Gravendijkwal 230
3015 CE
NL
Listed location countries
Age
Inclusion criteria
Age > 30 years
Exclusion criteria
Contraindications for CT coronary angiography, including:
- Inability to perform a breath hold for at least the expected scan time
- Persistent arrhythmias (e.g. atrial fibrillation)
- Known allergy to iodinated contrast media
- Impaired renal function (serum creatinine >120 µmol/l)
- Possible pregnancy
- Unstable clinical condition (angina at rest, hypotension, malignant arrhythmias)
- Body weight exceeding 120 kg
· Inability to position an 18 G cannula in an antecubital vein
· Unable to give informed consent or no informed consent obtained
Design
Recruitment
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 |
|---|---|
| CCMO | NL27074.078.09 |