Copeptin Registry (proCORE) Biomarkers in Cardiology (BIC)-19

Acute Myocardial Infarction Clinical Trial

— proCORE  

Official title:

Copeptin Registry (proCORE) Biomarkers in Cardiology (BIC)-19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02490969
• Other study ID #: BIC 19
• Status: Completed
• Phase: N/A
• First received: June 25, 2015
• Last updated: May 23, 2017
• Start date: September 2015
• Est. completion date: May 23, 2017

Study information

• Verified date: May 2017
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Registry of an interventional Study-proved Strategy (BIC-8) using Copeptin and Troponin for the Early Rule-Out of Acute Myocardial Infarction (AMI) in Patients with Suspected Acute Coronary Syndrome (ACS) and a low-to intermediate risk profile.

Description:

Registry of an interventional Study-proved Strategy (BIC-8) using Copeptin and Troponin for the Early Rule-Out of Acute Myocardial Infarction (AMI) in Patients with Suspected Acute Coronary Syndrome (ACS) and a low-to intermediate risk profile.

Primary objective:

To monitor the safety of the early rule-out strategy using combined testing of copeptin and troponin at admission of patients with signs and symptoms suggestive of ACS and a low- to intermediate risk profile, who are discharged or moved to another hospital after testing copeptin and troponin negative (defined as copeptin below 10 pmol/l and cardiac troponin below 99th percentile URL).

Secondary objectives:

• To monitor routine application of the early rule-out strategy, patient characteristics, risk profile of all patients tested for copeptin and troponin at admission, irrespective of their biomarker test result

• To monitor diagnoses, clinical course and outcome of all patients tested for copeptin and troponin at admission

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2256
• Est. completion date: May 23, 2017
• Est. primary completion date: May 23, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Admission to the Emergency Department or CPU with signs and symptoms consistent with acute coronary syndrome

• Low-to intermediate risk profile (GRACE-score below 140 and a low- to intermediate likelihood of ACS as judged by the treating physician)

• Patients eligible for the early rule-out strategy using combined copeptin and troponin testing at admission, irrespective of biomarker test results and disposition decision

• full-aged patient

Exclusion Criteria:

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Procedure:
• Routine management observation
Early rule out of myocardial infarction with combined copetine and troponin testing at admission

Locations

Country	Name	City	State
Germany	Charité - Universitätsmedizin Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality	One-month all-cause mortality in patients in whom acute myocardial infarction is ruled-out using the early rule-out strategy and who are therefore discharged from the ED	30 days