Evaluate the natural history of coronary artery disease and evaluate whether mid- to long-term plaque progression and changes measured with CCTA imaging can effectively predict CV events.
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 parameter to study will be the mean plaque progression measured with
follow-up CCTA imaging comparing between patients with and without MACE.
Secondary outcome
The secondary study parameters to be studied will be the following:
* Number of high risk plaque features, i.e.:
o positive remodelling (RI>1.1)
o low attenuation plaque (* 30 HU)
o spotty calcification
o napkin ring sign
* Relative mean plaque progression
* Difference in non-calcified plaque volume between baseline and follow-up CCTA
(delta non-calcified plaque volume)
* Difference in calcified plaque volume between baseline and follow-up CCTA
(delta calcified plaque volume)
* Coronary calcium score
* Plasma biomarker expression
Background summary
With the increasing burden of coronary artery disease (CAD), we are still
unable to identify patients at highest risk for recurrent events. With the
arrival of high-cost novel therapeutics, identifying these high-risk patients
is crucial. Recent studies have suggested that plaque progression over time is
an important predictor of cardiovascular (CV) events.
Study objective
Evaluate the natural history of coronary artery disease and evaluate whether
mid- to long-term plaque progression and changes measured with CCTA imaging can
effectively predict CV events.
Study design
Multicenter, observational, cross-sectional study
Study burden and risks
Participating subjects in this study receive no direct clinical benefits from
participation in this study. The burden and risk of participating in this study
is estimated to be low. The study requires one visit (90 minutes). Blood
withdrawal for clinical laboratory assessment will be 18 ml. Patients will be
exposed to a limited radiation burden related to CCTA imaging of 6 mSv.
Furthermore, there is a small risk of contrast nefropathy.
De Boelelaan 1118
Amsterdam 1081HV
NL
De Boelelaan 1118
Amsterdam 1081HV
NL
Listed location countries
Age
Inclusion criteria
- Aged 50 years and older
- Underwent CCTA imaging for clinical indications between 2008 and 2014
- Able to provide written informed consent
Exclusion criteria
- Renal insufficiency, defined as eGFR < 30 ml/min
- Atrial fibrillation
- Any other treatment or clinically relevant condition that could interfere
with the conduct or interpretation of the study in the opinion of the
investigator
- Inability or unwillingness to comply with the protocol requirements, or
deemed by investigator to be unfit for the study.
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 | NL73195.029.20 |