External Validation of the SCARE Score

Chest Pain Clinical Trial

— SCARE  

Official title:

Validation of the SCARE Score, Predictive Score of Acute Coronary Syndrome During the Assessment of Chest Pain in the Call Center.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04000490
• Other study ID #: CHRO-2019-05
• Status: Completed
• Start date: October 1, 2019
• Est. completion date: March 25, 2020

Study information

• Verified date: August 2020
• Source: Centre Hospitalier Régional d'Orléans
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

The main objective is to validate the predictive SCARE score of acute coronary syndrome during the medical assessment of chest pain. The primary endpoint will be SCARE score analysis (pre-established in 2016) with assessment of its calibration (Hosmer Lemeshow) and discrimination (AUC) in a multicenter population of chest pain with a potential diagnosis of Acute Coronary Syndrome established according to the European Society of Cardiology criteria.

This is a multi-center study including any patient over 18 years of age calling call center for chest pain over a period of six months. It will exclude post-traumatic chest pain, patients under 18 years old, patients who do not speak French, patients refusing to participate in the study or refusing treatment, patients not affiliated to social security, patients incarcerated in a penitentiary center, patients under tutorship, curatorship or safeguard of justice.

The collection of data will be carried out thanks to files filled prospectively by the medical physician for each call for the reason of a chest pain. These cards will list the epidemiological data (age, sex, weight, height) and clinical data of each patient, as well as the decision and the resources committed by the regulating physician (hospital care via SMUR or ambulance, treatment in city medicine). For hospitalized patients, the diagnosis of ACS will be retained if the patient meets the criteria defined by the European Society of Cardiology. For patients managed in ambulatory medicine, a telephone call to the patient will be made at one month to obtain the diagnosis.

Then, the SCARE score will be analized in this multicenter population with evaluation of its calibration (Hosmer Lemeshow) and discrimination (AUC). The characteristic performances of the score (sensitivity, specificity, PPV, NPV, positive and negative likelihood ratios)will also be analized.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2205
• Est. completion date: March 25, 2020
• Est. primary completion date: March 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Any patient over the age of 18 calling call center for chest pain

No-inclusion Criteria:

• Posttraumatic chest pain,

• Age under 18,

• Patient not speaking French,

• Patient refusing to participate in the study or refusing care

• Patient not affiliated with social security,

• Patients incarcerated in a penitentiary center,

• Patients under guardianship, curatorship or safeguard of justice.

Exclusion Criteria:

• Patient refusing to participate in the study or refusing care

Related Conditions & MeSH terms

• ACS - Acute Coronary Syndrome
• Acute Coronary Syndrome
• Assessment
• Chest Pain
• Syndrome

Intervention

Other:
• SCARE Score
Predictive Score of acute coronary syndrome during the medical assessment of chest pain

Locations

Country	Name	City	State
France	CHU Angers	Angers
France	CHRU de Tours	Chambray-lès-Tours
France	CHR d'Orléans	Orléans
France	CHU poitiers	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Régional d'Orléans

Country where clinical trial is conducted

France, 

References & Publications (3)

Faxon D, Lenfant C. Timing is everything: motivating patients to call 9-1-1 at onset of acute myocardial infarction. Circulation. 2001 Sep 11;104(11):1210-1. — View Citation

Mathew TP, Menown IB, McCarty D, Gracey H, Hill L, Adgey AA. Impact of pre-hospital care in patients with acute myocardial infarction compared with those first managed in-hospital. Eur Heart J. 2003 Jan;24(2):161-71. — View Citation

Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD; Joint ESC/ACCF/AHA/WHF Task Force for the Universal Definition of Myocardial Infarction, Katus HA, Lindahl B, Morrow DA, Clemmensen PM, Johanson P, Hod H, Underwood R, Bax JJ, Bonow RO, Pinto F, Gibbons RJ, Fox KA, Atar D, Newby LK, Galvani M, Hamm CW, Uretsky BF, Steg PG, Wijns W, Bassand JP, Menasché P, Ravkilde J, Ohman EM, Antman EM, Wallentin LC, Armstrong PW, Simoons ML, Januzzi JL, Nieminen MS, Gheorghiade M, Filippatos G, Luepker RV, Fortmann SP, Rosamond WD, Levy D, Wood D, Smith SC, Hu D, Lopez-Sendon JL, Robertson RM, Weaver D, Tendera M, Bove AA, Parkhomenko AN, Vasilieva EJ, Mendis S. Third universal definition of myocardial infarction. Circulation. 2012 Oct 16;126(16):2020-35. doi: 10.1161/CIR.0b013e31826e1058. Epub 2012 Aug 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SCARE score with evaluation of its calibration and its discrimination in a multicentric population	Data will be collected during each patient's call for chest pain. Epidemilogical data (age, sex, weight, height) and clinical data will be collected, as well as the decision and the ressources committed by the regulating physician. For hospitalized patients, the diagnosis of acute coronary sydrom will be retained if patient meets the criteria defined by the European Society of Cardiology. For patients managed in ambulatory médicine, a telephone call to the patient will be made at one month in order to obtain the diagnosis.	up to one month

External Links

•   thesis : Syndrome Coronarien Aigu (SCA) lors de la REgulation d'un appel au Centre 15 pour douleur thoracique : le score SCARE