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

Sponsor

Charite University, Berlin, Germany (Other)

Overall Status

Completed

CT.gov ID

NCT02490969

Collaborator

(none)

2,256

Enrollment

Location

20.7

Duration (Months)

109

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Acute Myocardial Infarction	Procedure: Routine management observation

Detailed Description

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

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

2256 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Sep 1, 2015

Actual Primary Completion Date :

May 23, 2017

Actual Study Completion Date :

May 23, 2017

Outcome Measures

Primary Outcome Measures

All-cause mortality [30 days]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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