Sequential Coronary CT-angiography and Biomarkers

Study Overview
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Brief Summary
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Currently, cardiac computed tomography angiography (CCTA) is a well-implemented non-invasive diagnostic imaging modality in patients with stable chest pain. Besides conventional CT-reading, CCTA is also capable to identify several morphologic and geometric characteristics of atherosclerotic plaques. Recently, the investigators showed that the use of semi-automated plaque quantification algorithm identified parameters predictive for acute coronary syndrome on top of clinical risk profiling and conventional CT-reading. In addition, several atherotrombosis biomarkers, like high-sensitivity cardiac troponins, are described as related to coronary artery disease and cardiovascular events. Prospective data with sequential analysis of atherosclerotic plaques combined with different atherothrombosis biomarkers are currently lacking, but will provide important clues about the pathophysiology of plaque progression and atherothrombosis.

Official Title
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Prediction of Atherosclerotic Plaque Burden Progression With Sequential Coronary CT-angiography and Biomarkers

Conditions
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Coronary Artery Disease, Atherosclerosis

Intervention / Treatment
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* Radiation: Coronary CT-angiography
* Other: Assesment of biomarkers involved in atherothrombosis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a recent history of (a)typical chest pain, who underwent a coronary calcium score scan as well as CCTA. Age older than 18 years and competent to perform written informed consent. At least 2 coronary segments with plaques: 1 proximal lesion. At least one coronary plaque consisting of a non-calcified or mixed component. Exclusion Criteria: Unstable angina. Renal insufficiency: calculated estimated glomerular filtration rate <45mL/min. Iodine allergy. Pregnancy. Known history of atrial fibrillation. Inconclusive baseline computed coronary CT-angiography. Patients which are currently on oral vitamin K antagonists. Patients which are currently using selective anticoagulants. Previous PCI. Previous or planned coronary artery bypass grafting. Patients whereby the baseline CCTA was performed by a retrospective ECG-gated 'helical' protocol due to a high (>90bpm) or irregular heart rate.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Serial CCTA and atherothrombosis markers<br>Sequential coronary CT-angiography and assesment of biomarkers involved in atherothrombosis after 1 year follow-up. | Radiation: Coronary CT-angiography<br>* Sequential CCTA after one year follow-up. The first CCTA will be performed in terms of diagnostic work-up (referral outpatient Cardiology department).<br>Other: Assesment of biomarkers involved in atherothrombosis<br>* Sequential assesment of atherothrombis biomarkers: baseline and at 1 year follow-up.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plaque progression as defined by sequential CCTA using dedicated software. |  | 1 year. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biological Markers, Multidetector Computed Tomography