The overall objective of this project is to assess the accuracy of SDCT for the detection of flow limiting stenosis in the coronary arteries using invasive FFR as the standard of reference. Whereby different subaims (e.g. improvement of FFRCT) are…
ID
Source
Brief title
Condition
- Coronary artery disorders
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 <0.8. To
determine the main endpoints, our study is divided in different aims. For each
aim, different factors, whether or not combined together, are used to assess
(improvement of) the main study endpoints. These factors are:
• Improved definition of coronary anatomy by reducing blooming of calcifications
• FFRCT
• Myocardial iodine distribution
• Dynamic mycocardial perfusion
Secondary outcome
Secondary study parameters and endpoints are degree of calcium blooming and
beam-hardening artifacts. A third parameter and endpoint is myocardial blood
volume quantification.
Background summary
Cardiovascular disease remains the leading cause of morbidity and mortality
worldwide. Coronary computed tomography angiography (CCTA) and, if indicated,
invasively measured fractional flow reserve (FFR) is currently used for ruling
out significant coronary artery disease. FFRCT is a novel non-invasive
technique in which FFR is derived from CT images, however this method is
currently, just like CCTA, lacking specificity. Spectral Detector CT (SDCT) is
a novel technique whereby a spectrum of monoenergetic images at different keV
values (40 to 140keV) can be reconstructed. By using these monoenergetic
images, tissue decomposition is possible and a decrease in blooming and
beam-hardening artifacts could be achieved. In addition, SDCT offers the
opportunity to assess myocardial iodine distribution and quantification. When
combining these factors, we hypothesize more accurate information will be
available about the coronary anatomy, degree of stenosis and FFRCT and thereby
contribute to a more accurate way for the detection of hemodynamic significant
stenosis. Therefore the aim of this study is to assess the accuracy of SDCT as
a non-invasive way for the detection of hemodynamically significant coronary
artery stenosis.
Study objective
The overall objective of this project is to assess the accuracy of SDCT for the
detection of flow limiting stenosis in the coronary arteries using invasive FFR
as the standard of reference. Whereby different subaims (e.g. improvement of
FFRCT) are made to answer the overall objective. The second objective is to
determine the decrease of blooming of calcifications and beam-hardening
artifacts and the improvement of myocardial blood volume quantification on SDCT
in comparison with conventional CT.
Study design
Prospective observational diagnostic mono-center study.
Study burden and risks
The patient will not benefit from participating in this study and will receive
routine care and an additional SDCT scan for research purposes. This study aims
to contribute to a non-invasive way of measuring hemodynamic significance in
coronary artery stenosis in future patients. The risks of this study are low.
The procedures performed are safe, with a small risk for side effects and/or
allergic reaction to adenisone, beta blockers, nitroglycerin and contrast
agent. The estimated extra radiation dose is below 10 mSv. Combined with the
clinically performed FFR measurement it is estimated to be 9-18 mSv. The (long
term) side effects of this amount of extra radiation are thought to be small.
This study has been assessed by the radiation safety committee. The burden for
the subjects is little: a few scans in one session, which will take <=30 min.
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL55917.041.16 |