Sequential Coronary CT-angiography and Biomarkers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2019-11-30

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.

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Detailed Description

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Conditions

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Coronary Artery Disease Atherosclerosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Serial CCTA and atherothrombosis markers

Sequential coronary CT-angiography and assesment of biomarkers involved in atherothrombosis after 1 year follow-up.

Group Type EXPERIMENTAL

Coronary CT-angiography

Intervention Type RADIATION

Sequential CCTA after one year follow-up. The first CCTA will be performed in terms of diagnostic work-up (referral outpatient Cardiology department).

Assesment of biomarkers involved in atherothrombosis

Intervention Type OTHER

Sequential assesment of atherothrombis biomarkers: baseline and at 1 year follow-up.

Interventions

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Coronary CT-angiography

Sequential CCTA after one year follow-up. The first CCTA will be performed in terms of diagnostic work-up (referral outpatient Cardiology department).

Intervention Type RADIATION

Assesment of biomarkers involved in atherothrombosis

Sequential assesment of atherothrombis biomarkers: baseline and at 1 year follow-up.

Intervention Type OTHER

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No