Coronary Artery Disease Clinical Trial
Official title:
Prospective Comparison of Cardiac PET/CT, SPECT/CT Perfusion Imaging and CT Coronary Angiography With Invasive Coronary Angiography
A large number of cardiac catheterizations are performed each year, primarily to diagnose heart disease. However, a cardiac catheterization is an invasive procedure which is associated with serious complications such as heart infarction, stroke, and death. Therefore, there is a need for non-invasive procedures to diagnose coronary heart disease. The purpose of this study is, therefore, to assess the diagnostic accuracy of non-invasive cardiac imaging modalities for the detection of heart disease in patients presenting for the first time to the cardiologist with chest pain.
Coronary artery disease (CAD) remains the leading cause of morbidity and mortality in
Western civilized countries. Early detection of CAD allows optimal therapeutic management in
order to decrease morbidity and mortality. In the Netherlands 80,000 invasive coronary
angiographies are performed each year. Invasive coronary angiography (ICA), particularly in
conjunction with fractional flow reserve (FFR) measurements, is considered the gold standard
in diagnosing and evaluating the severity of CAD in the current era. FFR measurements during
ICA are useful in determining whether a coronary stenosis is functionally important. An FFR
< 0.80 is considered abnormal, reflecting a hemodynamic significant coronary stenosis. ICA
has superior spatial and temporal resolution compared with non-invasive imaging techniques.
However, ICA is an invasive procedure which is associated with a low, though significant,
complication rate including bleeding, coronary artery dissections, cerebral embolism,
cardiac arrhythmias, myocardial infarction and death. Moreover, ICA provides only limited
information on the presence of atherosclerotic plaques not associated with luminal stenosis.
Furthermore, conventional catheter angiography without the advent of FFR measurements, is
not able to provide information about the hemodynamic significance of a significant luminal
stenosis (≥ 70%), i.e. whether a coronary artery stenosis is leading to myocardial perfusion
abnormalities. Therefore, there is a need for non-invasive imaging techniques for diagnosing
and evaluating the hemodynamic significance of CAD. Non-invasive techniques can serve as a
gatekeeper for invasive coronary angiographies in order to decrease the number of purely
diagnostic invasive angiographies and associated morbidity and mortality. The detection and
management of cardiovascular disease increasingly utilize non-invasive cardiac imaging in
patients with suspected or known CAD. By more accurately identifying patients who are
eligible for coronary revascularization with the use of non-invasive cardiac imaging, the
number of unnecessary invasive diagnostic coronary angiographies can be decreased.
Study design
Positron emission tomography:
PET images will be acquired using a Gemini Time-of-Flight (TF) 64 scanner (Philips
Healthcare, Best, The Netherlands). Quantitative myocardial perfusion at rest and during
hyperemia in ml -1. min -1. g -1 of myocardial tissue will be measured using
oxygen-15-labelled water (H215O). Pharmacological stress is induced by infusion of adenosine
intravenously at a rate of 140 µg/kg/min. Two minutes after the start of adenosine
vasodilation reaches a steady state and H215O will be given intravenously as a bolus
followed with the start of a 6-minutes emission scan. Directly after the PET sequence, a low
dose CT attenuation scan (CTAC) is acquired after which the infusion of adenosine is
terminated. Technetium-99m sestamibi is injected intravenously after the second CTAC scan. A
stress SPECT-scan is performed 45 minutes after the stress PET scan.
Single photon emission computed tomography:
SPECT imaging will be performed according to standard clinical protocols for myocardial
perfusion imaging. All patients will undergo SPECT-imaging(Symbia T2, Siemens, The Hague,
The Netherlands) on a during hyperaemia induced by infusion of adenosine at a rate of
140mcg/kg/min, using a dose of 400 megabecquerel (MBq) of Technetium (99mTc) tetrofosmin.
Tetrofosmin will be administered during adenosine induced stress during the time of the PET
stress perfusion scan. Directly after the stress SPECT-sequence, a low dose CT-attenuation
scan (CTAC) will be performed. A SPECT- rest imaging scan will be performed 72 hours after
the stress SPECT scan on the day of the catheterization.
Computed tomography:
Patients will undergo a coronary calcium score (CTCAC) and CT coronary angiography scan on a
256-slice CT scanner (Philips Brilliance iCT, Philips Healthcare, Best, the Netherlands).
Prospective ECG-gating (Step & Shoot Cardiac, Philips Healthcare, Best, The Netherlands) at
75 % of the R-R interval will be performed in order to minimize radiation burden.
Invasive coronary angiography:
ICA will be performed via a transfemoral of transradial approach according to the standard
procedure. Iodized contrast will be given intracoronary during the procedure to evaluate the
coronary artery lumen. The operator and an interventional cardiologist blinded to the
findings obtained with non-invasive imaging will evaluate the ICA images. ICA imaging will
be performed with a biplane or monoplane cardiovascular X-ray system (Allura Xper FD 10/10,
Philips Healthcare, Best, The Netherlands) in at least two orthogonal directions. After
primary coronary angiography, FFR will be measured in all coronary arteries, using a
0.014-inch sensor tipped guide wire. A stenosis with a FFR < 0.80 will be considered as a
hemodynamic significant stenosis. Clinical decision making will be based on the findings
obtained with ICA and FFR measurements and will be made by the interventional cardiologist.
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Observational Model: Cohort, Time Perspective: Prospective
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