Effects on intravascular attenuation of coronary arteries using low iodine concentrated contrast media while maintaining identical amount of iodine administered to patient per second

Effects on Intra-Coronary Attenuation using low iodine concentrations (240 mg, 300 mg and 370 mg iodine per ml) while maintaining identical IDR - EICAR

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-002437-37-NL

Enrollment

390

Registered

2014-03-18

Start date

2014-07-31

Completion date

Unknown

Last updated

2023-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

atypical or typical complaints of angina pectoris with no previous cardiovascular medical history low to intermediate risk for atherosclerosis referred for coronary CTA to rule out CAD

Interventions

Trade Name: Ultravist 240 Pharmaceutical Form: Solution for injection Trade Name: Ultravist 300 Pharmaceutical Form: Solution for injection Trade Name: Ultravist 370 Pharmaceutical Form: Solution fo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: no previous cardiovascular history atypical or typical complaints of angina patient aged older than 18 and competent 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 195 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 195

Exclusion criteria

Exclusion criteria: contraindications for cCTA (inability to perform a breath hold for at least expected scan time, unstable angina, hemodynamic instability, history of CAD, pregnancy, renal insufficiency defined as GFR <45 ml/min, iodine allergy) unable to give informed consent or no informed consent obtained inability to position an 18G cannula in an antecubital vein

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate intravascular contrast enhancement and image quality in coronary CTA using different iodine concentrations ranging form 240 to 370 mg iodine per ml, administered with an identical IDR.;Secondary Objective: To describe the effect of iodine concentration on contrast bolus characteristics, e.g. time to peak, bolus homogeneity and injection pressure.;Primary end point(s): Sufficient diagnostic intravascular enhancement after using lower concentrated contrast media.;Timepoint(s) of evaluation of this end point: As soon as all necessary data are included.	—

Measure

Time frame

Main Objective: To evaluate intravascular contrast enhancement and image quality in coronary CTA using different iodine concentrations ranging form 240 to 370 mg iodine per ml, administered with an identical IDR.;Secondary Objective: To describe the effect of iodine concentration on contrast bolus characteristics, e.g. time to peak, bolus homogeneity and injection pressure.;Primary end point(s): Sufficient diagnostic intravascular enhancement after using lower concentrated contrast media.;Timepoint(s) of evaluation of this end point: As soon as all necessary data are included.

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Secondary

Measure	Time frame
Secondary end point(s): Equal or better bolus homogeneity, time-to-peak and pressure curve during injection.;Timepoint(s) of evaluation of this end point: As soon as all necessary data are included.	—

Countries

Netherlands

Contacts

Public ContactMarco Das, Department of Radiology

Maastricht University Medical Centre

m.das@mumc.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026