Ruling Out Coronary Artery Disease and Myocardial Injury by Biomarkers

Overview

A considerable proportion of patients with clinically suspected coronary artery disease (CAD) do not have angiographic signs of luminal narrowing caused by coronary atherosclerosis. In patients with suspected CAD, we will assess the ability of cardiovascular biomarkers to identify patients with (a) angiographically normal epicardial coronary vessels (b) absence of significant epicardial coronary stenosis, as assessed by coronary computed tomography angiography (CCTA). Patients will be stratified according to the presence or absence of dynamic changes of high sensitivity cardiac troponin T levels above the 99th percentile.

Full Title of Study: “Ruling Out Coronary Artery Disease and Myocardial Injury by BiOmarkers: Light’n Easy”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: January 2022

Detailed Description

This is an observational study of patients with suspected coronary artery disease referred to coronary computed tomography angiography (CCTA). The plan is to include 1000 patients prior to CCTA at two centers.

Blood samples for biomarker measurement will be obtained prior to the procedures. The diagnostic results of the imaging tests will be compared to the levels of circulating troponins. Patient will be followed for a minimum of 12 months and the incidence of cardiovascular death, all-cause mortality, acute coronary syndromes, revascularization, heart failure, stroke and cardiac arrhythmias requiring rehospitalization. Symptoms of angina pectoris according to the Canadian Cardiovascular Society grading of angina pectoris and symptoms of chronic heart failure according to the New York Heart Association classification of chronic heart failure will be recorded.

Arms, Groups and Cohorts

  • Suspected coronary artery disease
    • Patients hospitalized for suspected acute coronary syndrome who are referred to CCTA or patients referred to CCTA from outpatient clinics for evaluation of stable coronary artery disease.

Clinical Trial Outcome Measures

Primary Measures

  • The presence of obstructive coronary artery stenosis defined as diameter > 50% on CCTA
    • Time Frame: 0 days (Cross-sectional)
    • Diagnostic end-point

Secondary Measures

  • The presence of non-obstructive coronary artery stenosis defined as diameter stenosis 30-50% on CCTA
    • Time Frame: 0 days (Cross-sectional)
    • Diagnostic end-point
  • Composite of cardiovascular death and hospitalization for heart failure or acute coronary syndrome
    • Time Frame: Follow-up until 2030
    • Prognostic end-point
  • Incidence of cardiovascular death, hospitalization for myocardial infarction, unstable angina, revascularization, stroke, heart failure and cardiac arrhythmias.
    • Time Frame: Follow-up until 2030
    • Prognostic-end-point

Participating in This Clinical Trial

Inclusion Criteria

  • Consenting patient over the age of 18 referred to CCTA for suspected coronary artery disease

Exclusion Criteria

  • Inability to provide informed consent.
  • Short life expectancy (<12 months) due to non-cardiovascular disease

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Akershus
  • Collaborator
    • Haukeland University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Torbjorn Omland, Professor – University Hospital, Akershus
  • Overall Official(s)
    • Torbjørn Omland, MD, PhD, Principal Investigator, University Hospital, Akershus
  • Overall Contact(s)
    • Torbjørn Omland, MD, PhD, 67960000, torbjorn.omland@medisin.uio.no

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