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NCT05058300 Clinical Trial

Prospective Registry for Patients With Chest Pain in Emergency Department

Chest Pain Clinical Trial

— ThReg  

Official title:
Prospective Registry for Patients With Chest Pain in Emergency Department

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05058300
Other study ID # 5149-04/17
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date September 20, 2017
Est. completion date October 11, 2024

Study information
Verified date November 2023
Source Jena University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 3000
Est. completion date October 11, 2024
Est. primary completion date March 23, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - age >18 years old chest pain written confirmation of participants or legal representative Exclusion Criteria: - thorax trauma

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• CT Thorax
CT Thorax (GE Revolution with chest pain algorithm)

Locations
Country Name City State
Germany Department of Emergency Jena Thuringia

Sponsors (3)
Lead Sponsor Collaborator
Jena University Hospital GE Healthcare, Zentrum für Klinische Studien Jena

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Sensitivity Sensitivity in result of biomarkers, risk scores and imaging methods During diagnostic procedure
Secondary Specificity Specificity in result of biomarkers, risk scores and imaging methods During diagnostic procedure
Secondary Positive predictive value Positive predictive value in result of biomarkers, risk scores and imaging methods During diagnostic procedure
Secondary Negative predictive value Negative predictive value in result of biomarkers, risk scores and imaging methods During diagnostic procedure
Secondary 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
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