Prospective Registry for Patients With Chest Pain in Emergency Department (ThReg)

monocentric, prospective registry collection of clinical data of all patients with chest pain in emergency department and follow-up after 30 days

Study Overview

• Status: Active, not recruiting
• Conditions: Chest Pain
• Intervention / Treatment: Device: CT Thorax

Detailed Description

An unselected patient-population with chest pain entering through the emergency department participate in a diagnostic survey where a chest pain algorithm based mainly on risk scores (Grace, TIMI, Heart) verifying the diagnostic forecasting power (sensitivity, specificity, negative and positive predictive value) of biomarkers, risk scores and imaging methods for diagnosing of potential life-threatening disease.

• Study Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

Study Locations

• Germany
  • Thuringia
    • Jena, Thuringia, Germany, 07747
      • Department of Emergency

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

An unselected patient-population with chest pain in emergency department

Description

Inclusion Criteria:

• age >18 years old chest pain written confirmation of participants or legal representative

Exclusion Criteria:

• thorax trauma

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with Chest Pain; An unselected patient-population with chest pain in emergency department	Device: CT Thorax; CT Thorax (GE Revolution with chest pain algorithm)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic forecast of biomarkers, risk scores and computer tomography	Diagnostic forecast compared to the initial suspected diagnosis and discharge diagnosis	From admission to emergency unit discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity	Sensitivity in result of biomarkers, risk scores and imaging methods	During diagnostic procedure
Specificity	Specificity in result of biomarkers, risk scores and imaging methods	During diagnostic procedure
Positive predictive value	Positive predictive value in result of biomarkers, risk scores and imaging methods	During diagnostic procedure
Negative predictive value	Negative predictive value in result of biomarkers, risk scores and imaging methods	During diagnostic procedure
Major adverse cardiac events (MACE)	outcome is measured by coronary intervention, coronary bypass and death within 30 days	From admission to emergency unit until 30 days after or death

Collaborators and Investigators

• Sponsor: Jena University Hospital
• Collaborators: GE Healthcare; Zentrum für Klinische Studien Jena
• Investigators: Principal Investigator: Wilhelm Behringer, Prof., Emergency Unit, University hospital Jena

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2017
• Primary Completion (Actual): March 23, 2022
• Study Completion (Estimated): October 11, 2024

Study Registration Dates

• First Submitted: July 17, 2017
• First Submitted That Met QC Criteria: September 17, 2021
• First Posted (Actual): September 27, 2021

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 6, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Chest Pain
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Disease Attributes; Emergencies; Chest Pain
• Other Study ID Numbers: 5149-04/17

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No