Ruling Out Coronary Artery Disease and Myocardial Injury by Biomarkers

Coronary Artery Disease Clinical Trial

— ROCAMBOLE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04144725
• Other study ID #: 2017/1874
• Status: Recruiting
• Start date: October 23, 2019
• Est. completion date: January 2030

Study information

• Verified date: January 2023
• Source: University Hospital, Akershus
• Contact: Torbjørn Omland, MD, PhD
• Phone: 67960000
• Email: torbjorn.omland[@]medisin.uio.no
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: January 2030
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
Norway	Akershus University Hospital	Lørenskog

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Akershus	Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The presence of obstructive coronary artery stenosis defined as diameter > 50% on CCTA	Diagnostic end-point	0 days (Cross-sectional)
Secondary	The presence of non-obstructive coronary artery stenosis defined as diameter stenosis 30-50% on CCTA	Diagnostic end-point	0 days (Cross-sectional)
Secondary	Composite of cardiovascular death and hospitalization for heart failure or acute coronary syndrome	Prognostic end-point	Follow-up until 2030
Secondary	Incidence of cardiovascular death, hospitalization for myocardial infarction, unstable angina, revascularization, stroke, heart failure and cardiac arrhythmias.	Prognostic-end-point	Follow-up until 2030