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Ruling Out Coronary Artery Disease and Myocardial Injury by Biomarkers

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04144725
Acronym
ROCAMBOLE
Enrollment
1000
Registered
2019-10-30
Start date
2019-10-23
Completion date
2030-01-01
Last updated
2026-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

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.

Interventions

None listed

Sponsors

University Hospital, Akershus
Lead SponsorOTHER
Haukeland University Hospital
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The presence of obstructive coronary artery stenosis defined as diameter > 50% on CCTA0 days (Cross-sectional)Diagnostic end-point

Secondary

MeasureTime frameDescription
The presence of non-obstructive coronary artery stenosis defined as diameter stenosis 30-50% on CCTA0 days (Cross-sectional)Diagnostic end-point
Composite of cardiovascular death and hospitalization for heart failure or acute coronary syndromeFollow-up until 2030Prognostic end-point
Incidence of cardiovascular death, hospitalization for myocardial infarction, unstable angina, revascularization, stroke, heart failure and cardiac arrhythmias.Follow-up until 2030Prognostic-end-point

Countries

Norway

Contacts

PRINCIPAL_INVESTIGATORTorbjørn Omland, MD, PhD

University Hospital, Akershus

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 10, 2026