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

May 23, 2017 updated by: Martin Moeckel, Charite University, Berlin, Germany
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

2256

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 13353
        • Charite - Universitatsmedizin Berlin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult men and women who present to an ED/CPU with signs and symptoms suggestive of acute coronary syndrome (NSTE-ACS) and an intermediate-to low risk profile in whom an early rule-out strategy for AMI is applied and who therefore undergo single combined troponin and copeptin testing at admission as part of standard management.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: 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
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Investigators

  • Principal Investigator: Martin Moeckel, MD, Charite University, Berlin, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

May 23, 2017

Study Completion (Actual)

May 23, 2017

Study Registration Dates

First Submitted

June 25, 2015

First Submitted That Met QC Criteria

July 2, 2015

First Posted (Estimate)

July 7, 2015

Study Record Updates

Last Update Posted (Actual)

May 24, 2017

Last Update Submitted That Met QC Criteria

May 23, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIC 19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data will be shared on reasonable request

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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