Sequential Coronary CT-angiography and Biomarkers

Not Applicable

• Conditions: Coronary Artery Disease; Atherosclerosis
• Interventions: Radiation: Coronary CT-angiography; Other: Assesment of biomarkers involved in atherothrombosis

• Registration Number: NCT02394262
• Lead Sponsor: Maastricht University Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-04
• Study First Submitted QC: 2015-03-16
• Study First Posted: 2015-03-20
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-27
• Last Update Posted: 2017-03-28
• Primary Completion: 2018-11
• Study Completion: 2019-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Serial CCTA and atherothrombosis markers	Coronary CT-angiography	Sequential coronary CT-angiography and assesment of biomarkers involved in atherothrombosis after 1 year follow-up.
Serial CCTA and atherothrombosis markers	Assesment of biomarkers involved in atherothrombosis	Sequential coronary CT-angiography and assesment of biomarkers involved in atherothrombosis after 1 year follow-up.

Primary Outcome Measures

Name	Time	Method
Plaque progression as defined by sequential CCTA using dedicated software.	1 year.

Trial Locations

Locations (1)

Maastricht University Medical Center; 🇳🇱 Maastricht, Limburg, Netherlands