Effects on intravascular attenuation of coronary arteries using low iodine concentrated contrast media while maintaining identical amount of iodine administered to patient per second
Phase 1
- Conditions
- atypical or typical complaints of angina pectoris with no previous cardiovascular medical historylow to intermediate risk for atherosclerosis referred for coronary CTA to rule out CADTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]
- Registration Number
- EUCTR2013-002437-37-NL
- Lead Sponsor
- Maastricht University Medical Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 390
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method 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.