Digital Decision Support in the Management of Patients With Chest Pain

NCT05767619 | Recruiting DMC

• 1 other identifier: 2022-01066-01
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 3

Brief Summary

The goal of this observational study is to develop a decision support system in patients presenting with chest pain in the prehospital setting. The main question it aims to answer is:

• Performance of a machine learning based model for decision support of patients in contact with emergency medical services due to chest pain Participants will be asked to:
• respond to questions asked by the clinician at the scene regarding previous known risk factors and pain characteristics
• consent to the collection of routinely available data from medical records
• consent of taking one blood sample capillary or venous (if perifer catheter is placed for standard care reasons) troponin and glucose which is measured at the scene, disposed, and the result is entered in the clinical report form.

Conditions

Chest Pain; Acute Coronary Syndrome; Chest--Diseases

Keywords

Emergency Medical Services; Machine Learning; Decision Support Systems; Point of Care Test; Chest pain

Outcome Measures

Primary Outcomes (1)

• Clinical outcome prediction of the decision support model based on a composite outcome

  The models predictive ability for classifying low risk and high risk patients. Including features collected from the clinician at the scene, patient characteristics, previous medical history, pain characteristics, time duration of pain/discomfort, ECG interpretation, vital signs,Troponin and Glucose measurements. A composite outcome is based on the following: 1. Time-sensitive diagnose at hospital discharge 2. Death within seven days 3. Adverse events within 72 hours Adverse events is defined as : cardiac arrest, ventricular arrhythmias, shock, convulsions, heart failure ,hypotension, syncope and loss of consciousness and associated with a grade 4 or 5 according to the CCTAE v 6.0. Multiple models will be developed with an ensemble of classifiers and evaluated determining the best model performance. Measures reported are discriminative performance of the model roc-AUC, calibration, sensitivity, specificity, accuracy, positive predictive value, negative predictive value.

  Time-sensitive condition: from EMS inclusion to hospital discharge follow-up time 1 day up to 100 days; Death: from EMS inclusion up to seven days; Adverse events: from EMS inclusion up to 72 hours.

Interventions

Troponin hs-cTnI DIAGNOSTIC_TEST

One sample of Troponin (hs-cTnI) is obtained and analyzed at the scene. Capillary blood sample or venous (lithium heparin) if peripheral venous catheter is inserted for standard care reasons. The sample is disposed after the result has been recorded in the clinical report form. The clinicians participating in the study are instructed and have been educated about the study to only collect the data (report form with measurements) and provide care as constituted by the guidelines. Patients will be monitored by board members that standard clinical care is provided.

Also known as: Siemens Atellica VTLi point of care instrument.

Plasma glucose DIAGNOSTIC_TEST

One sample of plasma glucose is obtained and analyzed at the scene. The sample is then disposed and the measured value is recorded in the clinical report form. P-glucose measurement is clinical practice in standard care and is measured on all patients with diabetes and patients with altered mental status or at the ambulance nurse discretion.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Previous data reports that in Sweden 10% of all primary assignments concerning patients with chest pain. The included sites are carrying out over 80,000 primary assignments annually. All patients in contact with the national emergency number where an ambulance is dispatched and the patient´s main symptom is chest pain or chest discomfort are eligible for inclusion if fulfilling the inclusion and exclusion criteria.

You may qualify if:

• Patient in contact with the emergency medical service and patient main symptom is chest pain or chest discomfort
• Primary assignment (not assessed by physician in primary care, hospital)

You may not qualify if:

• Assignment taking place outside participating emergency medical service organisation geographical catchment area
• Under 18 years of age
• Unwillingness to participate
• Unable to participate (language, dementia, etc.)
• Other

Sponsors & Collaborators

• Vastra Gotaland Region: lead
• Department of Prehospital Emergency Care, Region Halland, Sweden: collaborator
• Department of Prehospital Emergency Care, Skaraborg, Vastra Gotaland Region, Sweden: collaborator
• Sahlgrenska University Hospital: collaborator

Study Sites (3)

Department of Prehospital Emergency Care,Region Halland

Kungsbacka, Region Halland, Sweden

RECRUITING

Department of Prehospital Emergency Care, Sahlgrenska University Hospital

Gothenburg, Region Vastra Gotaland, 41104, Sweden

RECRUITING

Department of Prehospital Emergency Care, Skaraborg

Lidköping, Region Vastra Gotaland, Sweden

RECRUITING

Related Publications (1)

• Lokholm E, Magnusson C, Herlitz J, Ravn-Fischer A, Hammarsten O, Johansson M, Hallin K, Wibring K. The development of a decision support tool in the prehospital setting for acute chest pain - a study protocol for an observational study (BRIAN2). Scand J Trauma Resusc Emerg Med. 2025 Jan 6;33(1):4. doi: 10.1186/s13049-024-01314-x.

  PMID: 39762958 DERIVED

MeSH Terms

Conditions

Chest Pain; Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Carl Magnusson, PhD,RN

  University of Gothenburg, Sahlgrenska University hospital

  PRINCIPAL INVESTIGATOR

• Johan Herlitz, PhD,MD

  University of Borås

  STUDY DIRECTOR

• Araz Rawshani, PhD,MD

  University of Gothenburg, Sahlgrenska University hospital

  STUDY CHAIR

• Annica Ravn-Fischer, PhD,MD

  University of Gothenburg, Sahlgrenska University hospital

  STUDY CHAIR

• Angela Bång, PhD,RN

  Göteborg University

  STUDY CHAIR

• Kristoffer Wibring, PhD,RN

  Region Halland

  STUDY CHAIR

• Jan-Otto Andersson, Msc,RN

  Region Västra Götaland, Skaraborg

  STUDY CHAIR

• Christer Axelsson, PhD,RN

  University of Borås

  STUDY CHAIR

• Markus Lingman, PhD,MD

  Region Halland

  STUDY CHAIR

• Ola Hammarsten, PhD,MD

  University of Gothenburg, Sahlgrenska University hospital

  STUDY CHAIR

Central Study Contacts

Carl Magnusson, PhD,RN

CONTACT

+46708868620; carl.magnusson@vgregion.se

Kristoffer Wibring, PhD,RN

CONTACT

kristoffer.wibring@regionhalland.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head prehospital nurse, PhD

Study Record Dates

• First Submitted: February 25, 2023
• First Posted: March 14, 2023
• Study Start: May 15, 2023
• Primary Completion: March 1, 2025
• Study Completion (Estimated): March 1, 2027
• Last Updated: June 18, 2023

Record last verified: 2023-06

Locations

SE (3)