NCT05058300

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

September 20, 2017

Completed
4 years until next milestone

First Posted

Study publicly available on registry

September 27, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2022

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2024

Completed
Last Updated

November 7, 2023

Status Verified

November 1, 2023

Enrollment Period

4.5 years

First QC Date

July 17, 2017

Last Update Submit

November 6, 2023

Conditions

Chest Pain

Keywords

Chest Pain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Sensitivity

    During diagnostic procedure

  • Specificity

    During diagnostic procedure

  • Positive predictive value

    During diagnostic procedure

  • Negative predictive value

    During diagnostic procedure

  • Major adverse cardiac events (MACE)

    From admission to emergency unit until 30 days after or death

Study Arms (1)

Patients with Chest Pain

An unselected patient-population with chest pain in emergency department

Device: CT Thorax

Interventions

CT ThoraxDEVICE

CT Thorax (GE Revolution with chest pain algorithm)

Patients with Chest Pain

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

An unselected patient-population with chest pain in emergency department

You may qualify if:

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

You may not qualify if:

  • thorax trauma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Emergency

Jena, Thuringia, 07747, Germany

Location

MeSH Terms

Conditions

Chest Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Wilhelm Behringer, Prof.

    Emergency Unit, University hospital Jena

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

July 17, 2017

First Posted

September 27, 2021

Study Start

September 20, 2017

Primary Completion

March 23, 2022

Study Completion

October 11, 2024

Last Updated

November 7, 2023

Record last verified: 2023-11

Locations

DE(1)