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Recruiting NCT02381301

Biomarkers and Cardiac CT

Observational Coronary Artery Disease Atherosclerosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Venous blood sampling prior to CCTA..
Who it may be relevant to
Registry conditions: Coronary Artery Disease, Atherosclerosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Biomarkers and Cardiac Computed Tomography: Relationship Between Cardiovascular Biomarkers and Coronary Artery Disease in Patients Undergoing Cardiac Computed Tomography

Overview

Coronary artery disease (CAD) is the leading cause of morbidity and mortality in developed countries. In addition, many patients suffer from valvular and aortic disease. Although various tools are available to identify patients with cardiovascular (CV) disease at risk for major adverse cardiac events (MACE), the identification of these patients remains a clinical challenge. One promising avenue is the use of different serum biomarkers involved in atherothrombosis which could provide an easy and cost-effective step in risk stratification.

Interventions

  • Biological Venous blood sampling prior to CCTA.

Primary outcome measures

  • Data registration of patients undergoing CCTA and given written informed consent. [Time frame: 15 years.]
  • To detect these patients for cardiovascular disease and Long term CV outcome (MACE). [Time frame: 15 years.]
Secondary outcome measures (3)
  • The relationship of novel blood biomarkers with CCTA findings. [Time frame: 15 years.]
  • The predictive value of these biomarkers to predict CAD in patients undergoing CCTA. [Time frame: 15 years.]
  • The prognostic value of these biomarkers (in combination) to predict MACE. [Time frame: 15 years.]

Eligibility criteria

Inclusion criteria

  • Patients referred from the Cardiology clinic for routine CCTA.

Exclusion criteria

  • Pregnancy
  • Severe renal insufficiency
  • Severe allergy to contrast medium
  • Inability to obtain informed consent
  • Age below 18 years

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Netherlands · 1 center
  • Maastricht University Medical Center — Maastricht

Identifiers

NCT: NCT02381301 · METC 14-4-117

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗