Place of Copeptin-troponin Assay in the Elimination Diagnosis of Non-ST+ ACS (NCT05902117) | Clinical Trial Compass
CompletedNot Applicable
Place of Copeptin-troponin Assay in the Elimination Diagnosis of Non-ST+ ACS
France270 participantsStarted 2023-06-28
Plain-language summary
The aim of this study is to demonstrate that a combined troponin and copeptin assay can exclude non-ST+ ACS in patients with chest pain less than 6 hours old.
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:
* Patient ≥18 years old
* Presenting at the Pontoise emergency department by their own means / ambulance or patients taken care of by the SMUR and referred to the NOVO hospital - Pontoise site
* Chest pain less than 6 hours old
* Chest pain suggestive of ACS (compressive, intense pain, radiating into the arm and neck, mid-thoracic, left thoracic or epigastric location)
* Non-contributory ECG (no ST elevation, presence of bundle branch block)
* Informed and having expressed no objection
* Beneficiary of a social security system (or entitled person)
Non -Inclusion Criteria:
* Sus ST-segment shift on ECG (ACS ST+)
* Intermittent pain/unclear onset time
* Pregnant woman
* Pain in the context of trauma
* Patient under guardianship
* Patient does not speak or understand French
Exclusion Criteria:
* Non-ultrasensitive troponin measurement positive during the 1st SMUR sampling (\> 0.08 ng.dL)
* Patient not referred to the NOVO hospital - Pontoise site by the SMUR
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
Demonstrate that a combined troponin and copeptin assay can exclude non-ST+ ACS in patients with chest pain less than 6 hours old (sensitivity/specificity)
Timeframe: At the end of the study, an average of 8 month
2
Demonstrate that a combined troponin and copeptin assay can exclude non-ST+ ACS in patients with chest pain less than 6 hours old (negative predictive value)
Timeframe: At the end of the study, an average of 8 month