Clinical trial NCT04144725: Ruling Out Coronary Artery Disease and Myocardial Injury by Biomarkers
Official title: Ruling Out Coronary Artery Disease and Myocardial Injury by BiOmarkers: Light'n Easy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease
Lead sponsor: University Hospital, Akershus
Sponsor class: OTHER
Collaborators: name: Haukeland University Hospital
First posted: 2019-10-30
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This is an observational study of patients with suspected coronary artery disease referred to either emergent or out-patient coronary computed tomography angiography (CCTA)

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The presence of obstructive coronary artery stenosis defined as diameter > 50% on CCTA
timeFrame: 0 days (Cross-sectional)
Secondary outcomes:
measure: The presence of non-obstructive coronary artery stenosis defined as diameter stenosis 30-50% on CCTA
timeFrame: 0 days (Cross-sectional)
measure: Composite of cardiovascular death and hospitalization for heart failure or acute coronary syndrome
timeFrame: Follow-up until 2030
measure: Incidence of cardiovascular death, hospitalization for myocardial infarction, unstable angina, revascularization, stroke, heart failure and cardiac arrhythmias.
timeFrame: Follow-up until 2030
Other outcomes:
Locations:
city: Lørenskog
country: Norway
facility: Akershus University Hospital
Study officials:
affiliation: University Hospital, Akershus
name: Torbjørn Omland, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: