Is the rest and adenosine stress MBF and MFR based on MPI-CT not inferior to gold standard rest and adenosine stress 15O-water PET-CT?
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoint is the validation of MPI-CT against the gold standard
of 15O-water PET-CT.
The main parameter we are going to measure is stress myocardial blood flow
(MBF) and Myocardial Flow Reserve (MFR). Myocardial perfusion will be
calculated quantitatively by a software as MBF in ml/g/min based on CT
acquisitions. MBF is calculated on a per voxel basis by dividing the maximal
slope of time-attenuation curve (TAC) by the area under the maximum arterial
input function (AIF). The arterial input function is sampled from two regions
of interest (ROI) placed separately in the descending aorta with every table
position (cranial and caudal) and combined into one arterial input function.
The MFR is calculated as a ration of stress MBF to rest MBF.
MBF=(Max Slope TAC)/(Maximum AIF)
MFR = stress MBF / rest MBF
Secondary outcome
N/A
Background summary
The prevalence of Chronic Coronary Syndromes (CCS) ranges from 5-7% in women
aged 45-64 years to 10-12% in women aged 65-84 and from 4-7% in men aged 45-64
years to 12-14% in men aged 65-84. Although acute coronary symptoms are a clear
indication for intervention, stable CCS requires thorough diagnosis. In fact,
the COURAGE trial demonstrated that in CCS coronary revascularization as an
initial management strategy, without functional assessment of coronary
stenosis, offers no benefits over optimal pharmacologic therapy alone in
reducing mortality. According to the current guidelines, the presence of
significant myocardial ischemia, during stress, is the most important
indication to perform revascularization. The first adenosine stress MPI-CT was
performed in 2005 by Kurata. Since then, several trials have established the
significance of myocardial MPI-CT compared to reference standards as SPECT, ICA
(with or without FFR) and stress perfusion MRI. There is a variety of
non-invasive and invasive methods to assess myocardial ischemia.
Novel hybrid imaging modalities using SPECT-CT, PET-CT, MRI and CT (including
coronary computed tomography angiography-CCTA and MPI-CT) facilitate
non-invasive assessment of ischemia. Hybrid imaging is a technique combining
both functional and anatomical assessment of coronary arteries and thus holds
much promise for future clinical applications. So far, PET, MRI and SPECT have
become established tools to detect myocardial perfusion defects, with 15O-water
PET-CT as a gold standard due to the linear relationship between water and
blood flow. Due to high costs of water-PET and restricted availability, on
daily basis, SPECT remains the most common diagnostic tool. Notwithstanding its
clinical value, the radiation dose of SPECT (12.8 mSv) and lack of quantifiable
results, are main drawbacks of this method Importantly, MPI-CT can also be
used as a quicker, cheaper tool compared to PET and SPECT, however MPI-CT is
still in research phase and needs clinical validation. The benefit of MPI-CT is
combining both morphology (coronary stenosis) and functionality (myocardial
perfusion) in a single CT setting, which answers both crucial questions in
terms of CAD diagnosis. Moreover, because of relatively low cost of CT and
wider availability as compared with SPECT-CT and PET-CT, the waiting time for
diagnostic scan instead of one month may decrease to one week. Additionally, as
compared to SPECT test, which is planned for two days, the entire Contrast
Pilot II study will be performed within one day, which is also time efficient.
15O-water PET-CT is a well-established reference modality to assess myocardial
perfusion. The Biograph Vision PET-CT at the institute will be used to perform
rest and adenosine stress 15O-water PET-CT and Siemens SOMATOM Force will be
used to perform rest and adenosine stress MPI-CT.
The hypothesis is that the results of rest MBF, adenosine stress MBF and MFR
measured from MPI-CT are not inferior in myocardial ischemia detection as
compared to the gold standard 15O-water PET-CT. Due to exploratory nature of
this study this hypothesis cannot be fully tested.
If the MPI-CT will be as accurate as water-PET, this method can be applied in
everyday clinical practice, at lower costs and shorter time-to-diagnosis period
as compared to water-PET. Moreover, it will provide fully measurable indices
information in opposite to currently used SPECT-CT
Study objective
Is the rest and adenosine stress MBF and MFR based on MPI-CT not inferior to
gold standard rest and adenosine stress 15O-water PET-CT?
Study design
Proof-of-concept
Study burden and risks
The main risk of the study is the exposition to a higher radiation dose (12.6
mSv of MPI-CT). The benefit of MPI-CT is combining both morphology (coronary
stenosis) and functionality (myocardial perfusion) in a single CT setting,
because of relatively low cost, wider availability and faster acquisition time
as compared with SPECT-CT and PET-CT for the detection of functional ischemia.
Additional risk might be connected to adenosine injection.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet
all of the following criteria:
1. Patients admitted for CCS diagnosis and ischemia detection with
intermediate pre-test probability (PTP) between 15% and 85%3.
2. Patients able to give informed consent.
3. 40-80 years old.
Exclusion criteria
Renal insufficiency with the glomerular filtration rate less the
30ml/min/kg.
• Known or suspected iodinated contrast allergy.
• Coronary Artery Bypass Grafting (CABG).
• Atrial fibrillation or other arrhythmia.
• Tachycardia.
• Pacemaker.
• BMI larger than 35 kg/m2 or weight larger than 120 kg
• Not able to hold breath for 20-30 seconds
• Possible pregnancy
•Contraindications to adenosine
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 | NL79780.042.21 |