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NCT04000490: SCARE
External Validation of the SCARE Score
trial testing SCARE Score in Assessment in 2,205 participants. Completed in 25 March 2020.
25 March 2020
Quick facts
| Lead sponsor | Centre Hospitalier Régional d'Orléans |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 2,205 |
| Start date | 1 October 2019 |
| Primary completion | 25 March 2020 |
| Estimated completion | 25 March 2020 |
| Sites | 4 locations across France |
Drugs / interventions tested
- SCARE Score
Conditions studied
- Assessment — all drugs for Assessment →
- Chest Pain — all drugs for Chest Pain →
- ACS - Acute Coronary Syndrome — all drugs for ACS - Acute Coronary Syndrome →
Sponsor
Centre Hospitalier Régional d'Orléans
Who can join
18 and older, any sex, with Assessment or Chest Pain. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Chest pain is a very common reason for resorting to the call center. The etiologies are very varied, ranging from benign pathologies to some that may involve, in the short term, the vital prognosis such as Acute Coronary Syndrome (ACS). ACS is a partial or complete occlusion of a coronary artery that causes potentially irreversible myocardial pain unless prompt treatment is undertaken. ACS represents 120 000 cases per year in France and causes about 18 000 deaths. There is currently no support score for the assessment of chest pain. However, reducing the duration of management of ACS is essential in order to hope to reduce the associated morbidity and mortality. In 2016, SAMU45's team established a predictive ACS score for the assessement of chest pain in SAMU 45 (France) based on the prospective study of 1367 patients. Seven items significantly associated with this risk of ACS could be highlighted: age, sex, smoking, typicality (potentially constrictive chest pain radiating potentially to the shoulders and / or jaw) pain, inaugural character of pain (ie first episode of this type), presence of sweats and the physician's belief to be in the presence of an ACS. These seven variables make up the SCARE score. This had good internal discrimination (AUC at 0.81) and excellent calibration ("p" of Hosmer-Lemeshow at 0.74). This score makes it possible to stratify the risk of ACS, by using epidemiological elements but also the physician's belief, whose Negative Predictive Value (VPN) proved excellent. The objective of this new project is to confirm by an external validation via a multicentric study the robustness of this score and thus be able to consider its use in front of any chest pain regulated in France by a call center.
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 NCT04000490
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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 NCT04000490 (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 Centre Hospitalier Régional d'Orléans
- Last refreshed: 1 September 2020
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/NCT04000490.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing