To predict atherosclerotic plaque progression, and thus cardiovascular risk, by combining plaque quantification on CCTA with semi-automated software combined with biochemical characteristics, as defined by measuring biomarkers involved in…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• Plaque progression as determined by sequential semi-automated plaque
quantification on CCTA.
• Whether plaque progression can be predicted by combining plaque
quantification with biomarkers involved in atherothrombosis.
Secondary outcome
Not applicable.
Background summary
The disruption of an atherosclerotic plaque and intraluminal thrombus formation
are the pathological hallmarks of an acute coronary syndrome (ACS) in patients
with coronary artery disease (CAD), which subsequently can lead to cardiac
death. Despite advancements, identifying these patients at risk for an acute
cardiovascular event remains an important clinical challenge3. Cardiac computed
tomography angiography (CCTA) is currently a well-implemented diagnostic
imaging modality in patients with stable chest pain. Besides conventional
CT-reading (coronary calcium score, luminal stenosis severity, and extent of
CAD), CCTA is also capable to identify several morphologic and geometric
characteristics of atherosclerotic plaques. Recently we showed that the use of
semi-automated plaque quantification algorithm identified parameters predictive
for ACS on top of clinical risk profiling and conventional CT-reading. On the
other hand, several atherotrombosis biomarkers, like high-sensitivity cardiac
troponins, are described in literature as related to CAD and cardiovascular
events which are an important part of risk stratification strategies.
Prospective data with sequential analysis of atherosclerotic plaque progression
by semi-automated software combined with biomarkers involved in
atherothrombosis are currently lacking.
Study objective
To predict atherosclerotic plaque progression, and thus cardiovascular risk, by
combining plaque quantification on CCTA with semi-automated software combined
with biochemical characteristics, as defined by measuring biomarkers involved
in atherothrombosis.
Study design
Prospective, single-center cohort, feasibility study with sequential coronary
CCTA for the assesment of plaque progression combined with the measurement of
different biomarkers.
CCTA and samples of venous blood will be derived at baseline and 1-year after
given informed consent. The semiautomated plaque quantification software of
Siemens is going to be used to report the morphologic and geometric coronary
plaque characteristics and to measure plaque progression.
Study burden and risks
The risks associated with participation are the occurrence of a hematoma due to
blood sampling at the site of venipuncture (arm) and the radiation exposure -
baseline and 1-year after given informed consent. Within the proposed study,
only the follow-up CCTA is derived as an addition wherefore extra radiation
exposure. But with recent developments in image acquisition and reconstruction
technologies, nowadays CCTA is performed with relatively low radiation
exposure. Meanwhile, the benefit of a second CCTA is that plaque progression
can be determined and that we gain additive diagnostic information per patient
and that in cases of peculiarity measures can be taken like referral to a
medical specialist. Important is the fact that due to deriving serial CCTA and
atherothrombosis biomarkers new insights on coronary plaque progression can be
obtained since research on this is lacking.
P. Debyelaan 25
Maastricht 6202AZ
NL
P. Debyelaan 25
Maastricht 6202AZ
NL
Listed location countries
Age
Inclusion criteria
- Patients with a recent history of (a)typical chest pain, who underwent a coronary Calcium score scan as well as coronary CT-angiography.
- At least 2 coronary segments with atherosclerotic plaques, as defined by coronary CT-angiography.
Exclusion criteria
- Unstable angina.
- Renal insufficiency: calculated estimated glomerular filtration rate <45mL/min.
- Iodine allergy.
- Pregnancy.
- Patients which are currently on oral vitamin K antagonists and using selective anticoagulants.
- Known history of atrial fibrillation.
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 |
---|---|
Other | 02394262 |
CCMO | NL49261.068.14 |