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Sequential Coronary CT-angiography and Biomarkers

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02394262
Acronym
PARSEC-NET
Enrollment
140
Registered
2015-03-20
Start date
2015-03-31
Completion date
2019-11-30
Last updated
2017-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis, Coronary Artery Disease

Keywords

Biological Markers, Multidetector Computed Tomography

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.

Interventions

RADIATIONCoronary 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).

OTHERAssesment of biomarkers involved in atherothrombosis

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

Sponsors

Maastricht University Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Plaque progression as defined by sequential CCTA using dedicated software.1 year.

Countries

Netherlands

Contacts

Primary ContactBas Kietselaer, MD, PhD
b.kietselaer@mumc.nl+31433871587
Backup ContactSibel Altintas, MD
s.altintas@mumc.nl+31433881232

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026