Prospective Registry for Patients With Chest Pain in Emergency Department

Active, not recruiting

• Conditions: Chest Pain
• Interventions: Device: CT Thorax

• Registration Number: NCT05058300
• Lead Sponsor: Jena University Hospital

Brief Summary

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

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 Timeline

• Study First Submitted: 2017-07-17
• Study Start: 2017-09-20
• Study First Submitted QC: 2021-09-17
• Study First Posted: 2021-09-27
• Primary Completion: 2022-03-23
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-06
• Last Update Posted: 2023-11-07
• Study Completion: 2024-10-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

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

Exclusion Criteria

• thorax trauma

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with Chest Pain	CT Thorax	An unselected patient-population with chest pain in emergency department

Primary Outcome Measures

Name	Time	Method
Diagnostic forecast of biomarkers, risk scores and computer tomography	From admission to emergency unit discharge	Diagnostic forecast compared to the initial suspected diagnosis and discharge diagnosis

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Emergency; 🇩🇪 Jena, Thuringia, Germany