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

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ClinicalTrials.gov Identifier: NCT04144725
Recruitment Status : Recruiting
First Posted : October 30, 2019
Last Update Posted : March 17, 2023
Sponsor:
Collaborator:
Haukeland University Hospital
Information provided by (Responsible Party):
Torbjorn Omland, University Hospital, Akershus

Study Description
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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.

Condition or disease
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 Design
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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ruling Out Coronary Artery Disease and Myocardial Injury by BiOmarkers: Light'n Easy
Actual Study Start Date : October 23, 2019
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : January 2030

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. The presence of obstructive coronary artery stenosis defined as diameter > 50% on CCTA [ Time Frame: 0 days (Cross-sectional) ]
    Diagnostic end-point


Secondary Outcome Measures :
  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


Biospecimen Retention:   Samples Without DNA
Blood samples will be obtained by venipuncture by dedicated study personnel in relation to the routine pre-procedural clinical examination conducted the same day or the day before the CCTA. The samples will be left at room temperature to coagulate and subsequently centrifuged at ~1500g for 15 minutes, and the supernatant will be transferred to acid-handled plastic tubes and analyzed directly or stored at -80℃.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04144725


Contacts
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Contact: Torbjørn Omland, MD, PhD 67960000 torbjorn.omland@medisin.uio.no

Locations
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Norway
Akershus University Hospital Recruiting
Lørenskog, Norway
Contact: Sjur Tveit, MD         
Sponsors and Collaborators
University Hospital, Akershus
Haukeland University Hospital
Investigators
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Principal Investigator: Torbjørn Omland, MD, PhD University Hospital, Akershus
More Information
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Responsible Party: Torbjorn Omland, Professor, University Hospital, Akershus
ClinicalTrials.gov Identifier: NCT04144725    
Other Study ID Numbers: 2017/1874
First Posted: October 30, 2019    Key Record Dates
Last Update Posted: March 17, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases