Ruling Out Coronary Artery Disease and Myocardial Injury by Biomarkers

NCT ID: NCT04144725

Last Updated: 2025-12-12

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-10-23
• Study Completion Date: 2030-01-31

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.

Conditions

Coronary Artery Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Haukeland University Hospital

OTHER

Sponsor Role: collaborator

University Hospital, Akershus

OTHER

Sponsor Role: lead

Responsible Party

Torbjorn Omland

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Torbjørn Omland, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Akershus

Locations

Akershus University Hospital

Lørenskog, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Torbjørn Omland, MD, PhD

Role: CONTACT

torbjorn.omland@medisin.uio.no

67960000

Facility Contacts

Sjur Tveit, MD

Role: primary

Other Identifiers

2017/1874

Identifier Type: -

Identifier Source: org_study_id