Copeptin Registry (proCORE) Biomarkers in Cardiology (BIC... | NCT02490969

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

NCT02490969

Sponsor

Charite University, Berlin, Germany

Status

Completed

Last Update Posted

May 24, 2017Actual

Enrollment

2,256Actual

Phase

Not provided

Conditions

Acute Myocardial Infarction

Interventions

Routine management observation

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2015

Primary Completion Date

May 23, 2017Actual

Completion Date

May 23, 2017Actual

First Submitted Date

Jun 25, 2015

First Submission Date that Met QC Criteria

Jul 2, 2015

First Posted Date

Jul 7, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 23, 2017

Last Update Posted Date

May 24, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Martin Moeckel, Univ. Prof. Dr., Charite University, Berlin, GermanyPrincipal Investigator

Lead Sponsor

Charite University, Berlin, GermanyOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

28 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,256Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Routine management observation	Procedure	Early rule out of myocardial infarction with combined copetine and troponin testing at admission

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Martin Moeckel, MD	Charite University, Berlin, Germany	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Charité - Universitätsmedizin Berlin		Berlin		13353	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31340965	Derived	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.

ID	Term
D003919	Diabetes Insipidus
D004630	Emergencies

ID	Term
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications