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Clinical Trials/NCT02394262
NCT02394262
Unknown
Not Applicable

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

Maastricht University Medical Center1 site in 1 country140 target enrollmentMarch 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Artery Disease
Sponsor
Maastricht University Medical Center
Enrollment
140
Locations
1
Primary Endpoint
Plaque progression as defined by sequential CCTA using dedicated software.
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2015
End Date
November 2019
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Plaque progression as defined by sequential CCTA using dedicated software.

Time Frame: 1 year.

Study Sites (1)

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