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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON47021

Enrollment

Registered

2016-06-29

Start date

2017-03-29

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

coronary stenosis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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) 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.

Design outcomes

Primary

Measure	Time frame
The main study parameters are SDCT and invasively measured FFR. The main endpoints is sensitivity and specificity of SDCT for the detection of hemodynamically significant coronary artery stenosis defined as FFR	—

Secondary

Measure	Time frame
Secondary study parameters and endpoints are degree of calcium blooming and beam-hardening artifacts. A third parameter and endpoint is myocardial blood volume quantification.	—

Countries

Netherlands

Outcome results