Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT04144725

Ruling Out Coronary Artery Disease and Myocardial Injury by Biomarkers

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Akershus University Hospital

Lørenskog, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: 0 days (Cross-sectional)

    Diagnostic end-point

Secondary outcomes

  1. 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

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

    Time frame: Follow-up until 2030

    Prognostic end-point

  3. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Akershus

Other

Collaborators

  • Haukeland University Hospital

Registry information

Official study title

Ruling Out Coronary Artery Disease and Myocardial Injury by BiOmarkers: Light'n Easy

Acronym: ROCAMBOLE

Important dates

Study start
2019
Primary completion
2023
Study completion
2030
First posted
Oct 30, 2019
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.