Chest PainVALIDATENCT04950244
Diagnostic Evaluation of Out-of-hospital High-sensitivity Troponin I in Patients Presenting Chest Pain
An observational study of Chest Pain, run by Poitiers University Hospital at 1 site in France.
Trial summary
Conducting an analysis of the clinical performance of high-sensitivity cardiac troponin I, tested in the out-of-hospital setting, for ruling out cardiac origin in acute onset chest pain. Acute onset chest pain is a complex symptom to narrow down in the out-of-hospital setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chest Pain
- What is being tested?
- High-sensitivity cardiac troponin I (hs-cTnI)
- How many people
- 800 participants
- Where
- 1 siteFrance
- Study dates
- 20 Aug 2021to 16 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: overall population of callers to the emergency dispatch center
Who may be able to join
- Over 18 years of age
- Presenting with evocative acute onset chest pain
Who cannot join
- ECG modifications with ST segment elevations
- Patients for whom anginal origin was excluded in the out-of-hospital setting
- Medical evaluation in a delay inferior to 20 minutes
- Patients without medical insurance
- Pregnant or lactating women
- Patients under reinforced guardianship, minors, patients in hospice care
Trial locations and contacts
1 site in 1 country.
About this study
Conducting an analysis of the clinical performance of high-sensitivity cardiac troponin I, tested in the out-of-hospital setting, for ruling out cardiac origin in acute onset chest pain.
Acute onset chest pain is a complex symptom to narrow down in the out-of-hospital setting. This is due to the difficulty of obtaining pertinent information over the phone, and the absence of validated dispatch scores or criteria.
Read more
In France, the current standard of care relies on the rapid dispatch of Emergency Medical Response Teams along with a physician in patients presenting symptoms evocative of Coronary Artery Disease or Myocardial Infarction.
Typical anginal pain includes retrosternal pressure pain radiating to the jaw, neck, or left arm. Diagnostic work-up includes anamnesis, physical examination, routine blood work, and ECG.
In the absence of signification ST-segment modifications, the gold standard relies on trending serum Troponin T and I in the hospital setting .
This study aims to analyze the clinical performance of high-sensitivity cardiac Troponin I assays (hs-cTnI) in the out-of-hospital setting using a point-of-care device ; Atellica VTLi (Siemens Healthineers)
- Conditions
- Chest Pain
- Being tested
- High-sensitivity cardiac troponin I (hs-cTnI)
- Keywords
- High-sensitivity cardiac Troponin I, Troponin I HS
- Medical subject headings
- Chest Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-sensitivity cardiac troponin I (hs-cTnI)Diagnostic test
Capillary and veinous whole blood sampling for hs-cTnI was collected. The sample was tested at the bedside with a point-of-care device (Atellica VTLi, Siemens Healthineers).
The result of both hs-c TnI values obtained was blinded to the treating physician
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical performance of hs-cTnI for rule-out of cardiac origin of chest pain in the out of hospital setting
Determining the more appropriate cut off in terms of specificity and sensitivity to rule out chest pain in relation to coronary artery disease, based on the ROC curve.
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2021
- Study start20 Aug 2021
- Primary completion16 Oct 2023
- Study completion16 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chest PainStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04950244
- Sponsor's protocol ID
- VALIDATE
- Acronym
- VALIDATE
- Status last verified
- Jan 2023
- First submitted
- 22 Jun 2021
- Last updated
- 1 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Maunoury F, Couvreur R, Hausfater P, Guenezan J. Cost-effectiveness of prehospital high-sensitivity troponin i testing versus standard emergency department care in patients with suspected acute coronary syndrome in France. Health Econ Rev. 2026 Jul 25;16(1):121. doi: 10.1186/s13561-026-00832-x.
PubMed 42902060
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Evaluation of Out-of-hospital High-sensitivity Troponin I in Patients Presenting Chest Pain
- ClinicalTrials.gov ID
- NCT04950244
- Acronym / sponsor ID
- VALIDATE / VALIDATE
- Conditions
- Chest Pain
- Keywords
- High-sensitivity cardiac Troponin I, Troponin I HS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 20 Aug 2021 (actual)
- Primary completion
- 16 Oct 2023 (actual)
- Study completion
- 16 Nov 2023 (actual)
- First posted
- 6 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Conducting an analysis of the clinical performance of high-sensitivity cardiac troponin I, tested in the out-of-hospital setting, for ruling out cardiac origin in acute onset chest pain.
Acute onset chest pain is a complex symptom to narrow down in the out-of-hospital setting. This is due to the difficulty of obtaining pertinent information over the phone, and the absence of validated dispatch scores or criteria.
In France, the current standard of care relies on the rapid dispatch of Emergency Medical Response Teams along with a physician in patients presenting symptoms evocative of Coronary Artery Disease or Myocardial Infarction.
Typical anginal pain includes retrosternal pressure pain radiating to the jaw, neck, or left arm. Diagnostic work-up includes anamnesis, physical examination, routine blood work, and ECG.
In the absence of signification ST-segment modifications, the gold standard relies on trending serum Troponin T and I in the hospital setting .
This study aims to analyze the clinical performance of high-sensitivity cardiac Troponin I assays (hs-cTnI) in the out-of-hospital setting using a point-of-care device ; Atellica VTLi (Siemens Healthineers)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- overall population of callers to the emergency dispatch center
Key inclusion criteria (2 listed)
- Over 18 years of age
- Presenting with evocative acute onset chest pain
Key exclusion criteria (6 listed)
- ECG modifications with ST segment elevations
- Patients for whom anginal origin was excluded in the out-of-hospital setting
- Medical evaluation in a delay inferior to 20 minutes
- Patients without medical insurance
- Pregnant or lactating women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-sensitivity cardiac troponin I (hs-cTnI)Capillary and veinous whole blood sampling for hs-cTnI was collected. The sample was tested at the bedside with a point-of-care device (Atellica VTLi, Siemens Healthineers). The result of both hs-c TnI values obtained was blinded to the treating physician | Diagnostic test | – |
Primary outcome
Clinical performance of hs-cTnI for rule-out of cardiac origin of chest pain in the out of hospital setting
Time frame: 3 hours
Determining the more appropriate cut off in terms of specificity and sensitivity to rule out chest pain in relation to coronary artery disease, based on the ROC curve.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
- Derived from this study: PubMed 42902060Maunoury F, Couvreur R, Hausfater P, Guenezan J. Cost-effectiveness of prehospital high-sensitivity troponin i testing versus standard emergency department care in patients with suspected acute coronary syndrome in France. Health Econ Rev. 2026 Jul 25;16(1):121. doi: 10.1186/s13561-026-00832-x.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chest Pain, run by Poitiers University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical performance of hs-cTnI for rule-out of cardiac origin of chest pain in the out of hospital setting (time frame: 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04950244, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2024.