Ruling Out Coronary Artery Disease and Myocardial Injury by Biomarkers

NCT04144725 | Recruiting

• 1 other identifier: 2017/1874
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• The presence of obstructive coronary artery stenosis defined as diameter > 50% on CCTA

  Diagnostic end-point

  0 days (Cross-sectional)

Secondary Outcomes (3)

• The presence of non-obstructive coronary artery stenosis defined as diameter stenosis 30-50% on CCTA

  0 days (Cross-sectional)

• Composite of cardiovascular death and hospitalization for heart failure or acute coronary syndrome

  Follow-up until 2030

• Incidence of cardiovascular death, hospitalization for myocardial infarction, unstable angina, revascularization, stroke, heart failure and cardiac arrhythmias.

  Follow-up until 2030

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Akershus: lead
• Haukeland University Hospital: collaborator

Study Sites (1)

Akershus University Hospital

Lørenskog, Norway

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

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℃.

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Torbjørn Omland, MD, PhD

  University Hospital, Akershus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Torbjørn Omland, MD, PhD

CONTACT

67960000; torbjorn.omland@medisin.uio.no

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 3, 2019
• First Posted: October 30, 2019
• Study Start: October 23, 2019
• Primary Completion: December 31, 2023
• Study Completion (Estimated): January 1, 2030
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)