Ruling Out Coronary Artery Disease and Myocardial Injury by Biomarkers (NCT04144725) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Ruling Out Coronary Artery Disease and Myocardial Injury by Biomarkers
Norway1,000 participantsStarted 2019-10-23
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is focused on using biomarkers and imaging like CCTA to rule out coronary artery disease — could you walk me through what the CCTA procedure actually involves and whether it would add anything useful to what my current tests are already showing?
2Since this study is no longer actively recruiting new participants, does that mean the results might be available soon, and could those findings change how you'd approach diagnosing or ruling out blockages in my arteries?
3The trial is measuring whether artery blockages greater than 50% diameter can be identified through biomarkers — how does that threshold compare to what you'd normally use to decide whether I need treatment or intervention?
4This is listed as a 'Phase NA' study, which sounds like it may be more of a diagnostic or observational study rather than a treatment trial — does that mean the main risk here is from the tests themselves, like radiation from CCTA, rather than from an experimental drug or procedure?
5If this trial's approach of combining biomarkers with CCTA imaging turns out to be accurate, how might that compare to the standard diagnostic path I'm currently on, and is waiting to see those results something worth factoring into my care plan?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The presence of obstructive coronary artery stenosis defined as diameter > 50% on CCTA