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NCT04950244: VALIDATE
Diagnostic Evaluation of Out-of-hospital High-sensitivity Troponin I in Patients Presenting Chest Pain
trial testing High-sensitivity cardiac troponin I (hs-cTnI) in Chest Pain in 800 participants. Completed in 16 November 2023.
16 October 2023
Quick facts
| Lead sponsor | Poitiers University Hospital |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 800 |
| Start date | 20 August 2021 |
| Primary completion | 16 October 2023 |
| Estimated completion | 16 November 2023 |
| Sites | 1 location across France |
Drugs / interventions tested
- High-sensitivity cardiac troponin I (hs-cTnI)
Conditions studied
- Chest Pain — all drugs for Chest Pain →
Sponsor
Poitiers University Hospital
Who can join
18 and older, any sex, with Chest Pain. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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)
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04950244
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Chest Pain
Currently open trials in the same condition.
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- NCT06239974 — Vericiguat in Patients With Coronary Microvascular Dysfunction Causing Stable Chest Pain (V-COM) · NA · recruiting
- NCT06520150 — Evaluation of the Effectiveness of Two Methods of Regional Anesthesia During S-ICD Implantation Procedure. · NA · recruiting
- NCT07435168 — CHEST-CA: Study of Chest Pain and Hidden Cardiac Amyloidosis · NA · recruiting
Other Poitiers University Hospital trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04950244 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Poitiers University Hospital
- Last refreshed: 1 May 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04950244.
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