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出境医 / 临床实验 / External Validation of the SCARE Score (SCARE)

External Validation of the SCARE Score (SCARE)

Study Description
Brief 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.


Condition or disease Intervention/treatment
Assessment Chest Pain ACS - Acute Coronary Syndrome Other: SCARE Score

Detailed 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.

Study Design
Layout table for study information
Study Type : Observational
Actual Enrollment : 2205 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of the SCARE Score, Predictive Score of Acute Coronary Syndrome During the Assessment of Chest Pain in the Call Center.
Actual Study Start Date : October 1, 2019
Actual Primary Completion Date : March 25, 2020
Actual Study Completion Date : March 25, 2020
Arms and Interventions
Group/Cohort Intervention/treatment
patient with a chest pain
adult patient with a chest pain calling for urgency center
Other: SCARE Score
Predictive Score of acute coronary syndrome during the medical assessment of chest pain

Outcome Measures
Primary Outcome Measures :
  1. SCARE score with evaluation of its calibration and its discrimination in a multicentric population [ Time Frame: up to one month ]
    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.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any patient over the age of 18 calling call center for chest pain
Criteria

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

Contacts and Locations

Locations
Layout table for location information
France
CHU Angers
Angers, France, 49100
CHRU de Tours
Chambray-lès-Tours, France, 37170
CHR d'Orléans
Orléans, France, 45067
CHU poitiers
Poitiers, France, 86021
Sponsors and Collaborators
Centre Hospitalier Régional d'Orléans
Investigators
Layout table for investigator information
Principal Investigator: Audrey GUERINEAU, MD CHR Orléans
Principal Investigator: Paul Louis MARTIN, MD CHRU Tours - hopital trousseau
Principal Investigator: Thomas MOUMNEH, MD University Hospital, Angers
Principal Investigator: Jeremy GUENEZAN, MD CHU Poitiers
Tracking Information
First Submitted Date June 7, 2019
First Posted Date June 27, 2019
Last Update Posted Date September 1, 2020
Actual Study Start Date October 1, 2019
Actual Primary Completion Date March 25, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 26, 2019)
SCARE score with evaluation of its calibration and its discrimination in a multicentric population [ Time Frame: up to one month ]
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title External Validation of the SCARE Score
Official Title Validation of the SCARE Score, Predictive Score of Acute Coronary Syndrome During the Assessment of Chest Pain in the Call Center.
Brief 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.

Detailed 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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Any patient over the age of 18 calling call center for chest pain
Condition
  • Assessment
  • Chest Pain
  • ACS - Acute Coronary Syndrome
Intervention Other: SCARE Score
Predictive Score of acute coronary syndrome during the medical assessment of chest pain
Study Groups/Cohorts patient with a chest pain
adult patient with a chest pain calling for urgency center
Intervention: Other: SCARE Score
Publications *
  • 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.
  • 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.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 31, 2020)
2205
Original Estimated Enrollment
 (submitted: June 26, 2019)
2000
Actual Study Completion Date March 25, 2020
Actual Primary Completion Date March 25, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT04000490
Other Study ID Numbers CHRO-2019-05
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Centre Hospitalier Régional d'Orléans
Study Sponsor Centre Hospitalier Régional d'Orléans
Collaborators Not Provided
Investigators
Principal Investigator: Audrey GUERINEAU, MD CHR Orléans
Principal Investigator: Paul Louis MARTIN, MD CHRU Tours - hopital trousseau
Principal Investigator: Thomas MOUMNEH, MD University Hospital, Angers
Principal Investigator: Jeremy GUENEZAN, MD CHU Poitiers
PRS Account Centre Hospitalier Régional d'Orléans
Verification Date August 2020