To evaluate the predictive value of a combined risk score of proteomics, polygenic risk score and baseline CCTA imaging for ASCVD risk.
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main parameter to study will be the total coronary plaque volume
progression.
Secondary outcome
• Presence of obstructive stenosis (and number of vessels)
• Progression in number of significant (>50%) and severe (>70%) stenoses
• Absolute total plaque volume progression (mm3)
• Calcified plaque volume progression (mm3)
• Non-calcified plaque volume progression (mm3)
• Low-attenuation plaque volume progression (mm3)
• Change in Pericoronary Adipose Tissue CT-Attenuation (HU)
• CAD-RADS progression (yes/no)
• Progression in number of high-risk plaque characteristics (yes/no).
Background summary
Identification of patients at greatest atherosclerotic cardiovascular disease
(ASCVD) risk remains a major challenge in both primary prevention and secondary
prevention. With the introduction of high-throughput targeted proteomics,
polygenic risk scoring and improved coronary computed tomography angiography
(CCTA), combined with the advances in machine learning technologies, ample
opportunities for improved ASCVD risk prediction have arisen.
Study objective
To evaluate the predictive value of a combined risk score of proteomics,
polygenic risk score and baseline CCTA imaging for ASCVD risk.
Study design
Single center, observational, cohort study
Study burden and risks
The results of this study can contribute to the improved ASCVD risk
stratification in primary prevention to identify patients at high risk of
ASCVD.
Participating subjects in this study receive no direct clinical benefits from
clinical CCTA imaging. However, the expected risk for participants is low. The
most important risk in this study is radiation exposure. However, the maximum
exposure related to CCTA imaging is 2.8 mSv. This a low radiation exposure and
is comparable to the yearly dose of background radiation in the Netherlands.
Furthermore, ionized contrast agents will be used during CCTA, which can be
nephrotoxic and may elicit allergic reactions. In addition, incidental
extra-coronary findings, such as pulmonary malignancies, can be a potential
benefit from CCTA imaging since early detection of these findings may enable
early treatment. Cardiac findings, except for left main stenosis, will be
blinded until follow-up is completed.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
- Adult subjects between 50 and 75 years old.
- Subjects at intermediate to high risk for ASCVD
- Asymptomatic subjects without cardiac chest pain
- Evidence of atherosclerosis on baseline CCTA
Exclusion criteria
- Renal insufficiency, defined as eGFR < 30 ml/min
- History of cardiovascular events (myocardial infarction, peripheral artery
disease and ischemic stroke)
- Use of lipid lowering therapy other than statin, ezetimibe or bempedoic acid
monotherapy
- Change in lipid lowering therapy in the last 6 months
- Use of more than two antihypertensive agents
- No coronary atherosclerosis at baseline imaging
- Active malignancy requiring treatment
- 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 | NL81913.018.22 |