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Advantageous Predictors of Acute Coronary Syndromes Evaluation (APACE) Study: Validation

English title Advantageous Predictors of Acute Coronary Syndromes Evaluation (APACE) Study: Validation
Applicant Mueller Christian
Number 159495
Funding scheme Project funding (Div. I-III)
Research institution Klinik für Kardiologie Bereich Medizin Universitätsspital Basel
Institution of higher education University of Basel - BS
Main discipline Internal Medicine
Start/End 01.04.2015 - 31.03.2018
Approved amount 474'000.00
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All Disciplines (2)

Discipline
Internal Medicine
Clinical Cardiovascular Research

Keywords (4)

cardiac troponin; diagnosis; chest pain; acute myocardial infarction

Lay Summary (German)

Lead
Advantageous Predictors of Acute Coronary Syndromes Evaluation Study (APACE): Validation
Lay summary

Hintergrund: Der Herzinfarkt ist eine Hauptursache für Tod und Behinderung. Es betrifft eine von drei Personen in den entwickelten Ländern und wird durch die Blockierung der Durchblutung des Herzens verursacht, was zum Absterben der Herzmuskelzellen führt. Die schnelle Identifizierung des Herzinfarktes ist für den Beginn einer wirksamen Behandlung entscheidend. Die Elektrokardiographie und Bluttests, welche den Spiegel des Herztroponins messen - ein Protein was nur im Herz vorkommt, und welches als Folge von Herzmuskelzellschäden in den Kreislauf gelangt - bilden die aktuellen Diagnosen-Eckpfeiler und ergänzen die klinische Beurteilung. Die Entwicklung von hochempfindlichen Herztroponin-Tests, welche im Vergleich zu Tests von früheren Generationen in der Lage sind, Troponin bei viel geringeren Konzentrationen nachzuweisen, haben neue Möglichkeiten der Frühdiagnose, insbesondere die Entwicklung von 1h-Algorithmen, mit denen innerhalb 1h bei der Mehrzahl der Patienten, der Herzinfarkt entweder sicher ausgeschlossen oder nachgewiesen werden kann, ermöglicht.

 Ziele: Die Ziele der aktuellen Studie ist es, die Sicherheit und Effizienz der 1h-Algorithmen in einer Validierungskohorte zu überprüfen.
 Methodik: Wir werden fortlaufend Patienten rekrutieren, welche sich mit akuten Brustschmerzen in der Notaufnahme melden. Ein standardisierter Fragebogen wird dann ausgefüllt, Blutproben werden zu Beginn der Studie, sowie nach 1h, 2h, und 3h genommen und klinische Aufzeichnungen werden gesammelt.  Die endgültige Diagnose (= die wirkliche Ursache für akute Schmerzen in der Brust) wird durch zwei unabhängige Kardiologen gegeben, welche von allen Informationen Gebrauch machen werden, welche die einzelne Patienten betreffen.

 Mögliche Bedeutung: Diese Studie wird Erkenntnisse bieten, welche zur Verbesserung der Frühdiagnose des akuten Myokardinfarkts (AMI) beitragen werden, demzufolge wichtige klinische und wirtschaftliche Auswirkungen auf das Patientenmanagement haben.

Direct link to Lay Summary Last update: 07.04.2015

Responsible applicant and co-applicants

Employees

Publications

Publication

Collaboration

Group / person Country
Types of collaboration
Klinikum Nürnberg - Prof. Michael Christ Germany (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
- Research Infrastructure
- Exchange of personnel
Roche Diagnostics, Rotkreuz - Prof. Christian Zaugg Switzerland (Europe)
- Industry/business/other use-inspired collaboration
University Genoa - Paolo Ballarino, MD Italy (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
- Research Infrastructure
- Exchange of personnel
Public Research Center for Health, Luxemburg - Dr. Yvan Deveaux Luxembourg (Europe)
- Publication
Kantonsspital Olten - Professor Stefano Bassetti Switzerland (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
- Research Infrastructure
- Exchange of personnel
Hospital Clínic Barcelona - Professor Oscar Miró Spain (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
- Research Infrastructure
- Exchange of personnel
University Hospital Zürich - Prof. Thomas Lüscher Switzerland (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
- Research Infrastructure
- Exchange of personnel
University Hospital Brno - Prof. Jiri Parenica Czech Republic (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
- Research Infrastructure
- Exchange of personnel
University Clinic Hamburg-Eppendorf - Prof. Stefan Blankenberg Germany (Europe)
- Publication
- Research Infrastructure
Siemens, Erlangen - Dr. Alessandro Ortisi Germany (Europe)
- Industry/business/other use-inspired collaboration
Royal Brisbane and Women's Hospital, Brisbane - Prof. Louise Cullen Australia (Oceania)
- Publication
Hospital del Mar, University Barcelona - Professor Joaquim Gea Spain (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
- Research Infrastructure
- Exchange of personnel
Kantonsspital Luzern - Stephan Steuer, MD Switzerland (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
- Research Infrastructure
- Exchange of personnel
Beckman Coulter, Inc., Brea - Sherry Faye United States of America (North America)
- Industry/business/other use-inspired collaboration
BRAHMS, Henningsdorf - Dr. Ole Vollert Germany (Europe)
- Industry/business/other use-inspired collaboration
ECPM, University Basel - PD Matthias Schwenkglenks Switzerland (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
- Research Infrastructure
Geneva University Hospital, Geneva - Prof. Nicolas Vuilleumier Switzerland (Europe)
- Publication
Abbott Diagnostics, Wiesbaden - Dr. Lieselotte Lennartz Germany (Europe)
- Industry/business/other use-inspired collaboration
Christchurch Hospital, Christchurch - Prof. Martin Than New Zealand (Oceania)
- Publication
Klinik St. Anna Luzern - Prof. Paul Erne Switzerland (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
- Research Infrastructure
- Exchange of personnel

Scientific events



Self-organised

Title Date Place
International GREAT Meeting 06.07.2017 Barcelona, Spain

Communication with the public

Communication Title Media Place Year
Media relations: print media, online media CRIB today videos International 2016

Awards

Title Year
Otto Hess Award of the SGK 2018 to Patrick Badertscher Otto Hess Award of the SGK 2018 to Thomas Nestelberger Otto Hess Award of the SGK 2018 to Christian Puelacher Amgen SGK Award 2018 to Raphael Twerenbold Otto Hess Award of the SGK 2015 to Maria Rubini 2018

Associated projects

Number Title Start Funding scheme
135434 Advantageous Predictors of Acute Coronary Syndromes Evaluation (APACE) Study 01.04.2011 Project funding (Div. I-III)

Abstract

Acute myocardial infarction (AMI) is a major cause of death and disability. Rapid identification of AMI is critical for the initiation of effective treatment and management. Electrocardiography (ECG) and cardiac troponin (cTn) form the current diagnostic cornerstones and complement clinical assessment. The development of high-sensitivity cardiac troponin (hs-cTn) and copeptin assays and their initial clinical evaluation constitute the most important advances in the early diagnosis of AMI in recent years. Data from several groups including ours have helped to highlight their clinical potential. This includes the development of early rule-out and early rule-in algorithms. However, several important questions remain regarding these algorithms, including the observation that they will need to be assay-specific and have to be validated in a very large prospective validation cohort, before they can be recommended for widespread clinical use. The objectives of the current application are to extend the work in the ongoing and highly successful APACE study in order to provide additional insights for the refinements of the early diagnosis of AMI. Specifically, in the new application period we will a) increase the total number of recruited patients to 6000; b) validate the efficacy and safety of our recently developed 1h-hs-cTnT algorithm; c) derive and validate a new 1h-hs-cTnT algorithm incorporating the concept of very low/undetectable levels of hs-cTnT; d) derive and validate new 1h-hs-cTnI algorithms incorporating very low/undetectable levels of hs-cTnI and early changes using different assays e) derive and validate new 2h hs-cTnT and hs-cTnI algorithms (all previously mentioned assays); f) validate the recently developed accelerated diagnostic protocol combining a clinical score, ECG and hs-cTn at 0h and 2h for early rule-out; g) evaluate the accuracy of the current ESC 3h rule-out algorithm; h) derive and validate new 1h algorithms combining hs-cTn (all assays) and copeptin; i) derive and validate new 0h algorithms combining hs-cTn (all assays) and copeptin; j) directly compare the diagnostic accuracy of different hs-cTn assays at presentation as well as during serial sampling; k) evaluate whether the diagnostic accuracy of hs-cTn assays depends on the clinical likelihood for the presence of an acute coronary syndrome; l) determine the potential impact of hs-cTn and copeptin on resource use and costs; m) determine the potential effect of the clinical application of hs-cTnT on patient mortality as well as use of cardiac investigations length of stay, and costs; n) evaluate the diagnostic performance and derive + validate optimal clinical decision values of hs-cTn assays in underappreciated subgroups o) quantify and compare gender-specific diagnostic uncertainty among physicians evaluating women and men with suspected AMI; p) evaluate the utility, diagnostic accuracy, and impact on the incidence of AMI of gender-specific 99th percentiles as clinical decision values; q) explore remaining sources for misdiagnosis of AMI after the introduction of the “universal definition” of AMI and to quantify inconsistencies in the diagnosis of AMI related to the limitations of the current process on how to define the 99th percentile of hs-cTn assays; r) explore the release ratio and the linearity of release of cTnI and cTnT in AMI as well as noncardiac chest pain.This study will provide insights that will contribute to improvements in the early diagnosis of AMI and will therefore have important clinical and economic implications on patient management in Switzerland and worldwide.
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