EFFECT OF ISO-OSMOLAR CONTRAST MEDIUM ON CORONARY OPACIFICATION AND HEART RHYTHM IN CORONARY CT ANGIOGRAPHY (ISO-COR)

Conditions: coronary atherosclerosis
10011082

Registration Number: NL-OMON40326

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 300

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)

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Demonstrate comparable coronary opacification by iodixanol 270 (iso-osmolar<br /><br>contrast medium) in comparison to iopromide 300 (low-osmolar contrast medium),<br /><br>when injected with a comparable iodine flux.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Investigate additional differences between iodixanol and iopromide, in terms<br /><br>of:<br /><br>• Effect on heart rate, heart rate variability and arrhythmia<br /><br>• Venous contrast congestion (accumulation)<br /><br>• Qualitative and quantitative image quality<br /><br>• Patient discomfort and adverse events during and after injection</p><br>