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| Name | Class |
|---|---|
| Haukeland University Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| The presence of obstructive coronary artery stenosis defined as diameter > 50% on CCTA | Diagnostic end-point | 0 days (Cross-sectional) |
| Measure | Description | Time Frame |
|---|---|---|
| The presence of non-obstructive coronary artery stenosis defined as diameter stenosis 30-50% on CCTA | Diagnostic end-point | 0 days (Cross-sectional) |
| Composite of cardiovascular death and hospitalization for heart failure or acute coronary syndrome |
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Inclusion Criteria:
Exclusion Criteria:
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This is an observational study of patients with suspected coronary artery disease referred to either emergent or out-patient coronary computed tomography angiography (CCTA)
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| Name | Affiliation | Role |
|---|---|---|
| Torbjørn Omland, MD, PhD | University Hospital, Akershus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Akershus University Hospital | Lørenskog | Norway |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Blood samples will be obtained by venipuncture by dedicated study personnel in relation to the routine pre-procedural clinical examination conducted the same day or the day before the CCTA. The samples will be left at room temperature to coagulate and subsequently centrifuged at ~1500g for 15 minutes, and the supernatant will be transferred to acid-handled plastic tubes and analyzed directly or stored at -80℃.
Prognostic end-point
| Follow-up until 2030 |
| Incidence of cardiovascular death, hospitalization for myocardial infarction, unstable angina, revascularization, stroke, heart failure and cardiac arrhythmias. | Prognostic-end-point | Follow-up until 2030 |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |