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

NCT02490969 | Completed

• 1 other identifier: BIC 19
• Study Type: observational
• Target: 2,256
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myocardial Infarction

Keywords

copeptin; rule out marker, emergency department, cheast pain unit; emergency department; chest pain unit

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Routine management observation PROCEDURE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• none

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité - Universitätsmedizin Berlin

Berlin, 13353, Germany

Location

Related Publications (1)

• 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.

  PMID: 31340965 DERIVED

MeSH Terms

Conditions

Diabetes Insipidus; Emergencies

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases; Endocrine System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Martin Moeckel, MD

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 28 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Univ. Prof. Dr.

Study Record Dates

• First Submitted: June 25, 2015
• First Posted: July 7, 2015
• Study Start: September 1, 2015
• Primary Completion: May 23, 2017
• Study Completion: May 23, 2017
• Last Updated: May 24, 2017

Record last verified: 2017-05

Locations

DE (1)