Digital Decision Support in the Management of Patients With Chest Pain

NCT05767619 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 2000

Last updated 2023-06-18

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

Troponin hs-cTnI

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.

DIAGNOSTIC_TEST

Plasma glucose

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.

Sponsors & Collaborators

  • Department of Prehospital Emergency Care, Region Halland, Sweden

    collaborator UNKNOWN
  • Department of Prehospital Emergency Care, Skaraborg, Vastra Gotaland Region, Sweden

    collaborator UNKNOWN
  • Sahlgrenska University Hospital

    collaborator OTHER
  • Vastra Gotaland Region

    lead OTHER_GOV

Principal Investigators

  • Carl Magnusson, PhD,RN · University of Gothenburg, Sahlgrenska University hospital

  • Johan Herlitz, PhD,MD · University of Borås

  • Araz Rawshani, PhD,MD · University of Gothenburg, Sahlgrenska University hospital

  • Annica Ravn-Fischer, PhD,MD · University of Gothenburg, Sahlgrenska University hospital

  • Angela Bång, PhD,RN · Göteborg University

  • Kristoffer Wibring, PhD,RN · Region Halland

  • Jan-Otto Andersson, Msc,RN · Region Västra Götaland, Skaraborg

  • Christer Axelsson, PhD,RN · University of Borås

  • Markus Lingman, PhD,MD · Region Halland

  • Ola Hammarsten, PhD,MD · University of Gothenburg, Sahlgrenska University hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-15
Primary Completion
2025-03-31
Completion
2027-03-31

Countries

  • Sweden

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05767619 on ClinicalTrials.gov