Diagnostic accuracy of spectral computed tomography for detection of flow limiting coronary stenosis using fractional flow reserve as the standard of reference

Completed

Conditions: coronary stenosis
10011082
10003216

Registration Number: NL-OMON47021

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 75

Inclusion Criteria

- >=18 years old;
- Suspected or known stable angina with pre-test likelihood of 50-85% using the method recommended by the European Society of Cardiology 2013 Guidelines on the management of stable coronary artery disease (Eur Heart J 2013);
- Referred for invasive testing with fractional flow reserve;
- Willing and able to give informed consent.

Exclusion Criteria

- Subjects with suspected or known stable angina with pre-test likelihood of 0-50% using the method recommended by the European Society of Cardiology 2013 Guidelines on the management of stable coronary artery disease (Eur Heart J 2013);
- Subjects who because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent or tolerate the coronary CTA examination;
- Subjects with (severe) renal insufficiency, indicated as glomerular filtration rate (GFR) <60 ml/min;
- Subjects with unknown GFR or obtained >3 months before the planned scan;
- Contraindication or allergy to intravenous contrast agent(s);
- Subjects who participate in an other study with radiation which is estimated to be in risk category III (ICRP 62);
- Subjects who are pregnant;
- Subjects with contraindications to cardiac CT and/or step and shoot protocol, betablockers, adenosine or nitroglycerine.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameters are SDCT and invasively measured FFR. The main<br /><br>endpoints is sensitivity and specificity of SDCT for the detection of<br /><br>hemodynamically significant coronary artery stenosis defined as FFR <0.8. To<br /><br>determine the main endpoints, our study is divided in different aims. For each<br /><br>aim, different factors, whether or not combined together, are used to assess<br /><br>(improvement of) the main study endpoints. These factors are:<br /><br>• Improved definition of coronary anatomy by reducing blooming of calcifications<br /><br>• FFRCT<br /><br>• Myocardial iodine distribution<br /><br>• Dynamic mycocardial perfusion</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters and endpoints are degree of calcium blooming and<br /><br>beam-hardening artifacts. A third parameter and endpoint is myocardial blood<br /><br>volume quantification. </p><br>