1.To determine whether there is additional value of performing CAC score, CTCA and total aorta calcification (TAC) burden as compared to traditional risk factors in the risk stratification in patients at high cardiovascular risk in predicting any…
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
Combined endpoint of cardiovascular events (cardiovascular death, non-fatal
myocardial infarction and non-fatal ischemic stroke)
Secondary outcome
-Coronary artery intervention (PCI, CABG)
-Carotid desobstruction or stenting
-Non-fatal rupture, stenting or operation of an abdominal aorta aneurysm ,
-Amputation, PTA (percutaneous transluminal angioplastic) or stenting due to
peripheral artery disease
-All cause mortality
Background summary
After having had a first cardiovascular event, there is a considerable risk of
developing a subsequent event. Only recently, a risk predictionmodel was
developed for this group of patients. Imaging techniques such as the coronary
calcium score and computed tomography angiography could be able to add accuracy
to this model. When better risk stratification is possible, patients at the
highest risk can be monitored and treated more intensively. When imaging
techniques prove to be useful in the risk prediction model, a trial should be
performed evaluating the effects on outcome measures such as morbidity and
mortality
Study objective
1.To determine whether there is additional value of performing CAC score, CTCA
and total aorta calcification (TAC) burden as compared to traditional risk
factors in the risk stratification in patients at high cardiovascular risk in
predicting any cardiovascular event.
2.To estimate the additional value of CTCA and CAC score on top of traditional
risk factors in predicting cardiac events in patients at high risk.
3.To determine the value of soft plaque burden in the carotid and coronary
arteries in predicting vascular events in patients at high cardiovascular risk.
Study design
An observational cohort study, imbedded in the SMART study
Study burden and risks
Patients participating in the study will undergo a CT-scan with contrast of the
neck till abdomen, performing both coronary/total aortic calcium scores as well
as CT-angiography of the coronary vessels and carotid arteries. This CT-scan
will be imbedded in the program of the original SMART (2) measurements and will
take approximately 30 minutes. Both radiation and contrast will be used in
performing the CT-scan, with a maximum of 8mSv of radiation and low-volume
contrast. Patients with renal dysfunction will be either excluded from the
study or will receive hydration (depending on their eGFR) to minimize the risk
of contrast nephropathy. Adequate medication will be present in case of an
allergic reaction to contrast.
Heidelberglaan 100 Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100 Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
Patients participating in either SMART or SMART-2 and who have one of the
following:
- History of cardiovascular event (Coronary artery disease, Cerebrovascular
disease, including TIA or Peripheral artery disease, including aortic aneurysm)
- Diabetes Mellitus type 2
- Hypertension
Exclusion criteria
-Known renal failure (defined as eGFR <30 ml/min/1.73 m2 estimated by MDRD
formula)
-Previous allergic reaction to contrast, making medical intervention necessary
-Other contra-indication for CT-scanning
-Previous exposure to radiation for scientific purposes without advantage for
the patient
Design
Recruitment
Medical products/devices used
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 | NL36828.041.11 |