Ruling Out Coronary Artery Disease and Myocardial Injury by Biomarkers (ROCAMBOLE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease

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.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Torbjørn Omland, MD, PhD; Phone Number: 67960000; Email: torbjorn.omland@medisin.uio.no

Study Locations

• Norway
  • Lørenskog, Norway
    • Recruiting
    • Akershus University Hospital
    • Contact: Sjur Tveit, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The presence of obstructive coronary artery stenosis defined as diameter > 50% on CCTA	Diagnostic end-point	0 days (Cross-sectional)

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University Hospital, Akershus
• Collaborators: Haukeland University Hospital
• Investigators: Principal Investigator: Torbjørn Omland, MD, PhD, University Hospital, Akershus

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2019
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): January 1, 2030

Study Registration Dates

• First Submitted: May 3, 2019
• First Submitted That Met QC Criteria: October 28, 2019
• First Posted (Actual): October 30, 2019

Study Record Updates

• Last Update Posted (Actual): March 17, 2023
• Last Update Submitted That Met QC Criteria: March 16, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: 2017/1874

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No