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ROCAMBOLE: Ruling Out Coronary Artery Disease and Myocardial Injury by Biomarkers

Sponsor
University Hospital, Akershus (Other)
Overall Status
Recruiting
CT.gov ID
NCT04144725
Collaborator
Haukeland University Hospital (Other)
1,000
Enrollment
1
Location
122.3
Anticipated Duration (Months)
8.2
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Anticipated 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 :
    Oct 23, 2019
    Anticipated Primary Completion Date :
    Jan 1, 2022
    Anticipated Study Completion Date :
    Jan 1, 2030

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Primary Outcome Measures

    1. The presence of obstructive coronary artery stenosis defined as diameter > 50% on CCTA [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 [0 days (Cross-sectional)]

      Diagnostic end-point

    2. Composite of cardiovascular death and hospitalization for heart failure or acute coronary syndrome [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. [Follow-up until 2030]

      Prognostic-end-point

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Akershus University Hospital Lørenskog Norway

    Sponsors and Collaborators

    • University Hospital, Akershus
    • Haukeland University Hospital

    Investigators

    • Principal Investigator: Torbjørn Omland, MD, PhD, University Hospital, Akershus

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Torbjorn Omland, Professor, University Hospital, Akershus
    ClinicalTrials.gov Identifier:
    NCT04144725
    Other Study ID Numbers:
    • 2017/1874
    First Posted:
    Oct 30, 2019
    Last Update Posted:
    Oct 30, 2019
    Last Verified:
    Oct 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Coronary Artery Disease
    Myocardial Ischemia
    Coronary Disease

    Study Results

    No Results Posted as of Oct 30, 2019