Project

Back to overview

BASEL IX (BAsel Syncope EvaLuation Study): Validation

English title BASEL IX (BAsel Syncope EvaLuation Study): Validation
Applicant Mueller Christian
Number 175604
Funding scheme Project funding (Div. I-III)
Research institution Abteilung für Kardiologie Universitätsspital Basel
Institution of higher education University of Basel - BS
Main discipline Internal Medicine
Start/End 01.10.2017 - 30.09.2020
Approved amount 682'500.00
Show all

Keywords (3)

diagnosis; Cardiac syncope; biomarkers

Lay Summary (German)

Lead
Eine Synkope ist eine kurzdauernde Bewusstlosigkeit, welche meist zu einem Sturz führt. Synkopen treten relativ häufig auf und machen ca. 1-2% aller Besuche in einer Notfallstation aus. Einer Synkope können mehrere verschiedene Ursachen zu Grunde liegen. Einige sind sehr gefährlich und akut lebensbedrohlich, andere eher harmlos.
Lay summary

Hintergrund: Die Hauptaufgabe für die ärztliche Beurteilung auf der Notfallstation ist zu Erkennen, ob eine akut lebensbedrohliche Ursache vorliegt, weil diese eine Spitalaufnahme und unmittelbare Behandlung bedarf. Bei den akut lebensbedrohlichen Ursachen, steht fast immer eine Herzerkrankung im Vordergrund, z.B. eine Herzrhythmusstörung oder eine Herzklappenerkrankung. Auf der Notfallstation ist es oft sehr schwierig und sehr zeitaufwendig, die akut lebensbedrohlichen Ursachen von den harmlosen Ursachen zu unterscheiden.

In der ersten Phase von BASEL IX, die hauptsächlich in Notfallstationen in der Schweiz durchgeführt wurde, entstanden mehrere wichtige Erkenntnisse zur verbesserten Früherkennung der lebensbedrohlichen Formen der Synkope. Es gibt jedoch weiter zahlreiche ungelöste Fragen, insbesondere die Notwendigkeit, die bisherigen Erkenntnisse in eine, zweiten großen Patientenkollektiv zu überprüfen. Erst dann können die neuen Erkenntnisse weltweit Anwendung finden.

Ziele: Ziel der zweiten Phase von BASEL IX (BAsel Syncope EvaLuation Study) ist, die bisher sehr erfolgreiche Studie auszuweiten, um die Generalisierbarkeit der ersten Befunde zu testen und zusätzliche Erkenntnisse für die Früherkennung der akut lebensbedrohlichen Form der Synkope zu erhalten.
Methodik: BASEL IX ist eine große laufende prospektive internationale diagnostische Studie, an der Patienten mit Synkope in dreizehn Spitälern in acht Ländern auf drei Kontinenten teilnehmen. Es wird von einem dynamischen Netzwerk akademischer, klinischer und industrieller Partner durchgeführt, die auf dem Gebiet der Synkope und kardialer Biomarker erfahren sind. In der zweiten Phase von BASEL IX (BASEL IX Validation) werden wir weitere 2'000 Patienten einschliessen.

Potentielle Bedeutung: Diese Studie wird Erkenntnisse liefern, die zur Verbesserung der Früherkennung von akut lebensbedrohlichen Ursachen der Synkope liefern und damit wichtige klinische und wirtschaftliche Auswirkungen auf das Patientenmanagement in der Schweiz und weltweit haben.

Direct link to Lay Summary Last update: 10.11.2017

Responsible applicant and co-applicants

Employees

Project partner

Publications

Publication
Incidence, characteristics, determinants, and prognostic impact of recurrent syncope
Zimmermann Tobias, du Fay de Lavallaz Jeanne, Nestelberger Thomas, Gualandro Danielle M, Strebel Ivo, Badertscher Patrick, Lopez-Ayala Pedro, Widmer Velina, Freese Michael, Miró Òscar, Christ Michael, Cullen Louise, Than Martin, Martin-Sanchez F Javier, Di Somma Salvatore, Peacock W Frank, Keller Dagmar I, Boeddinghaus Jasper, Twerenbold Raphael, Wussler Desiree, Koechlin Luca, Walter Joan E, Bürgler Franz, Geigy Nicolas, Kühne Michael, Reichlin Tobias, Lohrmann Jens, Mueller Christian (2020), Incidence, characteristics, determinants, and prognostic impact of recurrent syncope, in EP Europace.
Prevalence of Pulmonary Embolism in Patients With Syncope
Badertscher Patrick, du Fay de Lavallaz Jeanne, Hammerer-Lercher Angelika, Nestelberger Thomas, Zimmermann Tobias, Geiger Marc, Imahorn Orell, Miró Òscar, Salgado Emilio, Christ Michael, Cullen Louise, Than Martin, Martin-Sanchez F. Javier, Di Somma Salvatore, Peacock W. Frank, Keller Dagmar I., Costabel Juan Pablo, Walter Joan, Boeddinghaus Jasper, Twerenbold Raphael, Méndez Adriana, Gospodinov Boris, Puelacher Christian, Wussler Desiree, Mueller Christian (2019), Prevalence of Pulmonary Embolism in Patients With Syncope, in Journal of the American College of Cardiology, 74(6), 744-754.
B-Type Natriuretic Peptides and Cardiac Troponins for Diagnosis and Risk-Stratification of Syncope
du Fay de Lavallaz Jeanne, Badertscher Patrick, Nestelberger Thomas, Zimmermann Tobias, Miró Òscar, Salgado Emilio, Christ Michael, Geigy Nicolas, Cullen Louise, Than Martin, Javier Martin-Sanchez F., Di Somma Salvatore, Frank Peacock W., Morawiec Beata, Walter Joan, Twerenbold Raphael, Puelacher Christian, Wussler Desiree, Boeddinghaus Jasper, Koechlin Luca, Strebel Ivo, Keller Dagmar I., Lohrmann Jens, Michou Eleni, Mueller Christian (2019), B-Type Natriuretic Peptides and Cardiac Troponins for Diagnosis and Risk-Stratification of Syncope, in Circulation, 139(21), 2403-2418.
Circadian, weekly, seasonal, and temperature-dependent patterns of syncope aetiology in patients at increased risk of cardiac syncope
du Fay de Lavallaz Jeanne, Badertscher Patrick, Nestelberger Thomas, Flores Dayana, Miró Òscar, Salgado Emilio, Geigy Nicolas, Christ Michael, Cullen Louise, Than Martin, Martin-Sanchez F Javier, Rodriguez-Adrada Esther, Di Somma Salvatore, Peacock W Frank, Kawecki Damian, Boeddinghaus Jasper, Twerenbold Raphael, Puelacher Christian, Wussler Desiree, Strebel Ivo, Keller Dagmar I, Poepping Imke, Kühne Michael, Reichlin Tobias, Müller Christian (2019), Circadian, weekly, seasonal, and temperature-dependent patterns of syncope aetiology in patients at increased risk of cardiac syncope, in EP Europace, 21(3), 511-521.
Prospective validation of prognostic and diagnostic syncope scores in the emergency department
du Fay de Lavallaz Jeanne, Badertscher Patrick, Nestelberger Thomas, Isenrich Rahel, Miró Òscar, Salgado Emilio, Geigy Nicolas, Christ Michael, Cullen Louise, Than Martin, Martin-Sanchez F. Javier, Bustamante Mandrión José, Di Somma Salvatore, Peacock W. Frank, Kawecki Damian, Boeddinghaus Jasper, Twerenbold Raphael, Puelacher Christian, Wussler Desiree, Strebel Ivo, Keller Dagmar I., Poepping Imke, Kühne Michael, Mueller Christian, Reichlin Tobias (2018), Prospective validation of prognostic and diagnostic syncope scores in the emergency department, in International Journal of Cardiology, 269, 114-121.
Prohormones in the Early Diagnosis of Cardiac Syncope
Badertscher Patrick, Nestelberger Thomas, de Lavallaz Jeanne du Fay, Than Martin, Morawiec Beata, Kawecki Damian, Miró Òscar, López Beatriz, Martin‐Sanchez F. Javier, Bustamante José, Geigy Nicolas, Christ Michael, Di Somma Salvatore, Peacock W. Frank, Cullen Louise, Sarasin François, Flores Dayana, Tschuck Michael, Boeddinghaus Jasper, Twerenbold Raphael, Wildi Karin, Sabti Zaid, Puelacher Christian, Rubini Giménez Maria, Osswald Stefan, ReichlinTobias, MuellerChristian (2017), Prohormones in the Early Diagnosis of Cardiac Syncope, in Journal of the American Heart Association, 6(12), 1.

Collaboration

Group / person Country
Types of collaboration
Benjamin Sun / Penn University Perelman School of Medicine United States of America (North America)
- in-depth/constructive exchanges on approaches, methods or results
Venkatesh Thiruganasambandamoorthy / University of Otawa Canada (North America)
- in-depth/constructive exchanges on approaches, methods or results
- Publication

Scientific events



Self-organised

Title Date Place
International GREAT XII Meeting 27.06.2019 Edinburgh, Great Britain and Northern Ireland
International GREAT XI Meeting 05.07.2018 Venice, Italy

Communication with the public

Communication Title Media Place Year
Media relations: print media, online media CRIB Today videos, 2019 International 2017

Awards

Title Year
Medtronic Young Surgeon Award (SGHC) 2019
Otto Hess Trainee Award 2019

Associated projects

Number Title Start Funding scheme
138403 BASEL IX - Basel Syncope Evaluation Study 01.01.2012 Project funding (Div. I-III)

Abstract

Background: Syncope is frequent and represents 1-2% of all Emergency Department (ED) visits. The ED-evaluation of patients with syncope is challenging, generally time and resource consuming. In the first phase of BASEL IX, which was mainly conducted in EDs in Switzerland, several important insights and novel diagnostic algorithms emerged. However, numerous important questions remain regarding these algorithms, particularly the need to be validated in a large prospective validation cohort before they can be recommended for widespread clinical use. Aims: The aim of the current application is to extend the work in the ongoing and highly successful BASEL IX (BAsel Syncope EvaLuation Study) in order to test the generalizability of the initial findings and to provide additional insights for diagnosis and risk stratification.Methodology: BASEL IX is a large ongoing prospective international diagnostic study enrolling unselected patients presenting with syncope to the ED in thirteen hospitals in eight countries on three continents. It is conducted by a dynamic network of academic, clinical and industry collaborators experienced in the field of syncope and cardiac biomarkers. In the new application period (BASEL IX Validation) we will enroll 2’000 additional patients. It is our primary objective to validate the diagnostic performance of the recently developed algorithm implementing the combination of a low ED-probability and a low plasma level of midregional pro A-type natriuretic peptide (MRproANP) against a gold standard diagnosis adjudicated centrally by two independent cardiologists according to the latest European Society of Cardiology (ESC) guidelines using all information becoming available during clinical work-up including 1-year follow-up. Secondary objectives include the evaluation of a) age-, circadian, and sex-optimized cut-off levels for MR-proANP and ED clinical judgment to derivate and validate personalized diagnostic algorithms b) other biochemical signatures including other natriuretic peptides (e.g. B-type natriuretic peptide and NT-proBNP) c) electrocardiographic signatures to improve the early diagnosis of cardiac syncope. As the main causes of cardiac syncope are arrhythmic disorders, ECG-signals may provide incremental value in diagnosing cardiac syncope. The latter includes the attempt to incorporate an ECG-marker into our algorithm combining clinical judgement and a cardiac biomarker to further improve its accuracy, efficacy and safety d) the prevalence of pulmonary embolism as the cause of syncope among patients presenting to the ED and e) the best clinical use of implantable loop recorders in the management of patients with unexplained syncope.Potential significance: This study will provide insights that will contribute to improvements in diagnosis and risk stratification of cardiac syncope and will therefore have important clinical and economic implications on patient management in Switzerland and worldwide.
-