EFFECT OF CONTRAST MEDIUM ON CORONARY OPACIFICATION AND HEART RHYTHM IN CORONARY CT's (ICO-COR)

Conditions: Patients with suspected coronary artery disease and clinically referred for coronary CTA.
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

Registration Number: EUCTR2014-000681-22-NL

Lead Sponsor: ErasmusMC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

•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)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>Mean attenuation measured in the mid LAD (7), proximal LCX (11) and mid RCA (2), averaged per patient. Requirements: <br>•Vessel: minimal diameter 2 mm, good or moderate image quality. <br>•ROI size: circular shape, minimum 50 pixels per sample. <br>•ROI placement: axial images, center of the vessel, optimal image quality, <br>;Timepoint(s) of evaluation of this end point: After the last included patient' scan is performed

Secondary Outcome Measures