ThReg: Prospective Registry for Patients With Chest Pain in Emergency Department

• Sponsor: Jena University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05058300
• Collaborator: Zentrum für Klinische Studien Jena (Other), GE Healthcare (Industry)
• Enrollment: 3,000
• Location: 1
• Anticipated Duration (Months): 57.7
• Patients Per Site Per Month: 52

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Chest Pain	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 Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 3000 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Prospective Registry for Patients With Chest Pain in Emergency Department
• Actual Study Start Date: Sep 20, 2017
• Anticipated Primary Completion Date: Mar 23, 2022
• Anticipated Study Completion Date: Jul 11, 2022

Arms and Interventions

Arm	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)

Outcome Measures

Primary Outcome Measures

1. 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

1. Sensitivity [During diagnostic procedure]

   Sensitivity in result of biomarkers, risk scores and imaging methods

2. Specificity [During diagnostic procedure]

   Specificity in result of biomarkers, risk scores and imaging methods

3. Positive predictive value [During diagnostic procedure]

   Positive predictive value in result of biomarkers, risk scores and imaging methods

4. Negative predictive value [During diagnostic procedure]

   Negative predictive value in result of biomarkers, risk scores and imaging methods

5. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

• thorax trauma

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Emergency	Jena	Thuringia	Germany	07747

Sponsors and Collaborators

• Jena University Hospital
• Zentrum für Klinische Studien Jena
• GE Healthcare

Investigators

• Principal Investigator: Wilhelm Behringer, Prof., Emergency Unit, University hospital Jena

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ulf Teichgräber, Prof. Dr. med., Jena University Hospital
• ClinicalTrials.gov Identifier: NCT05058300
• Other Study ID Numbers: 5149-04/17
• First Posted: Sep 27, 2021
• Last Update Posted: Sep 27, 2021
• Last Verified: Sep 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ulf Teichgräber, Prof. Dr. med., Jena University Hospital: Chest Pain
• Additional relevant MeSH terms: Emergencies; Chest Pain

Study Results

No Results Posted as of Sep 27, 2021