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

NCT ID: NCT02490969

Last Updated: 2017-05-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2256 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2017-05-23

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.

Detailed 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

Conditions

Acute Myocardial Infarction

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Routine management observation

Early rule out of myocardial infarction with combined copetine and troponin testing at admission

Intervention Type: PROCEDURE

Eligibility Criteria

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

• none

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Martin Moeckel

Univ. Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Martin Moeckel, MD

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

Charité - Universitätsmedizin Berlin

Berlin, , Germany

Countries

Germany

References

Giannitsis E, Clifford P, Slagman A, Ruedelstein R, Liebetrau C, Hamm C, Honnart D, Huber K, Vollert JO, Simonelli C, Schroder M, Wiemer JC, Mueller-Hennessen M, Schroer H, Kastner K, Mockel M. Multicentre cross-sectional observational registry to monitor the safety of early discharge after rule-out of acute myocardial infarction by copeptin and troponin: the Pro-Core registry. BMJ Open. 2019 Jul 23;9(7):e028311. doi: 10.1136/bmjopen-2018-028311.

Reference Type: DERIVED

PMID: 31340965 (View on PubMed)

Other Identifiers

BIC 19

Identifier Type: -

Identifier Source: org_study_id