BAsel Syncope EvaLuation (BASEL IX) Study

NCT01548352 | Active Not Recruiting

• 1 other identifier: BASEL IX
• Study Type: observational
• Target: 3,500
• Locations: 9 countries
• Sites: 15

Brief Summary

Syncope is a major health problem. In the emergency department (ED), the management of patients with syncope still remains a clinical challenge because underlying diseases and prognosis can be extremely various. Structural heart disease and primary electrical disorders are major risk factors for sudden cardiac death and mortality in patients with syncope. In contrast, patients with reflex syncope and exclusion of structural heart disease have an excellent prognosis. Therefore The investigators test the hypothesis that the use of a meticulous patient history, clinical examination and novel biomarkers can improve the rapid and accurate diagnosis of cardiac syncope in patients presenting to the ED and is able to improve risk stratification regarding adverse outcomes. The prospective multicenter cohort study is designed to enroll 720 patients presenting with transient loss of consciousness within the last 12 hours to the ED. Blood samples for the measurement of novel biomarkers will be obtained at presentation. All patients will be contacted by phone at 6, 12 and 24 months to determine major adverse events (death, resuscitation, recurrence of syncope, hospitalization for syncope).

Conditions

Syncope

Keywords

Syncope; Unconsciousness; Syncope, vasovagal, neurally-mediated; Syncope, cardiogenic; Cardiac arrhythmia; Sudden cardiac death; Syncopal episode

Outcome Measures

Primary Outcomes (1)

• Diagnostic and prognostic value of various novel and established biomarkers, clinical assessment and detailed patient history

  To test the diagnostic performance of predefined elements of a standardized patient history, overall clinical judgement using a visual analogue scale, and novel biomarkers in the diagnosis of cardiac syncope in patients presenting to the ED.

  within 24 months

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients presenting to the emergency department with syncope within the last 12 hours.

You may qualify if:

• Patients presenting to the emergency department
• Age \> 40 years
• Syncope within the last 12 hours
• Written informed consent

You may not qualify if:

• Age \< 40 years
• Patients without loss of consciousness and with certain neurological causes (e.g. recurrent epilepsy, hemiplegia at presentation)
• No written informed consent

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Swiss National Science Foundation: collaborator

Study Sites (15)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Instituto Cardiovascular de Buenos Aires

Buenos Aires, C1428, Argentina

Location

Royal Brisbane and Women's hospital

Brisbane, QLD 4029, Australia

Location

Klinikum Nürnberg

Nuremberg, Bavaria, 90419, Germany

Location

Sant'Andrea Hospital

Rome, 00189, Italy

Location

Christchurch Hospital

Christchurch, New Zealand

Location

Medical University of Silesia

Zabrze, Poland

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

Hospital Clinic of Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitario Clínico San Carlos

Madrid, 28040, Spain

Location

Kantonsspital Baselland

Liestal, Basel-Landschaft, 4410, Switzerland

Location

Spital Lachen

Lachen, Canton of Schwyz, 8853, Switzerland

Location

University Hospital Basel

Basel, 4031, Switzerland

Location

Luzern Kantonsspital

Lucerne, 6000, Switzerland

Location

University Hospital Zurich

Zurich, 8091, Switzerland

Location

Related Publications (6)

• Zimmermann T, du Fay de Lavallaz J, Walter JE, Strebel I, Nestelberger T, Joray L, Badertscher P, Flores D, Widmer V, Geigy N, Miro O, Salgado E, Christ M, Cullen L, Than M, Martin-Sanchez FJ, Di Somma S, Peacock WF, Keller D, Costabel JP, Wussler DN, Kawecki D, Lohrmann J, Gualandro DM, Kuehne M, Reichlin T, Sun B, Mueller C; BASEL IX and SRS Investigators. Development of an electrocardiogram-based risk calculator for a cardiac cause of syncope. Heart. 2021 Nov;107(22):1796-1804. doi: 10.1136/heartjnl-2020-318430. Epub 2021 Jan 27.

  PMID: 33504514 DERIVED

• Zimmermann T, du Fay de Lavallaz J, Nestelberger T, Gualandro DM, Strebel I, Badertscher P, Lopez-Ayala P, Widmer V, Freese M, Miro O, Christ M, Cullen L, Than M, Martin-Sanchez FJ, Di Somma S, Peacock WF, Keller DI, Boeddinghaus J, Twerenbold R, Wussler D, Koechlin L, Walter JE, Burgler F, Geigy N, Kuhne M, Reichlin T, Lohrmann J, Mueller C. Incidence, characteristics, determinants, and prognostic impact of recurrent syncope. Europace. 2020 Dec 23;22(12):1885-1895. doi: 10.1093/europace/euaa227.

  PMID: 33038231 DERIVED

• Badertscher P, du Fay de Lavallaz J, Hammerer-Lercher A, Nestelberger T, Zimmermann T, Geiger M, Imahorn O, Miro O, Salgado E, Christ M, Cullen L, Than M, Martin-Sanchez FJ, Di Somma S, Peacock WF, Keller DI, Costabel JP, Walter J, Boeddinghaus J, Twerenbold R, Mendez A, Gospodinov B, Puelacher C, Wussler D, Koechlin L, Kawecki D, Geigy N, Strebel I, Lohrmann J, Kuhne M, Reichlin T, Mueller C; BASEL IX Investigators. Prevalence of Pulmonary Embolism in Patients With Syncope. J Am Coll Cardiol. 2019 Aug 13;74(6):744-754. doi: 10.1016/j.jacc.2019.06.020.

  PMID: 31395124 DERIVED

• du Fay de Lavallaz J, Badertscher P, Nestelberger T, Zimmermann T, Miro O, Salgado E, Christ M, Geigy N, Cullen L, Than M, Javier Martin-Sanchez F, Di Somma S, Frank Peacock W, Morawiec B, Walter J, Twerenbold R, Puelacher C, Wussler D, Boeddinghaus J, Koechlin L, Strebel I, Keller DI, Lohrmann J, Michou E, Kuhne M, Reichlin T, Mueller C; BASEL IX Investigators. B-Type Natriuretic Peptides and Cardiac Troponins for Diagnosis and Risk-Stratification of Syncope. Circulation. 2019 May 21;139(21):2403-2418. doi: 10.1161/CIRCULATIONAHA.118.038358. Epub 2019 Feb 25.

  PMID: 30798615 DERIVED

• du Fay de Lavallaz J, Badertscher P, Nestelberger T, Isenrich R, Miro O, Salgado E, Geigy N, Christ M, Cullen L, Than M, Martin-Sanchez FJ, Bustamante Mandrion J, Di Somma S, Peacock WF, Kawecki D, Boeddinghaus J, Twerenbold R, Puelacher C, Wussler D, Strebel I, Keller DI, Poepping I, Kuhne M, Mueller C, Reichlin T; BASEL IX Investigators; Gimenez MR, Walter J, Kozhuharov N, Shrestha S, Mueller D, Sazgary L, Morawiec B, Muzyk P, Nowalany-Kozielska E, Freese M, Stelzig C, Meissner K, Kulangara C, Hartmann B, Ferel I, Sabti Z, Greenslade J, Hawkins T, Rentsch K, von Eckardstein A, Buser A, Kloos W, Lohrmann J, Osswald S. Prospective validation of prognostic and diagnostic syncope scores in the emergency department. Int J Cardiol. 2018 Oct 15;269:114-121. doi: 10.1016/j.ijcard.2018.06.088. Epub 2018 Jun 21.

  PMID: 30224031 DERIVED

• Badertscher P, Nestelberger T, de Lavallaz JDF, Than M, Morawiec B, Kawecki D, Miro O, Lopez B, Martin-Sanchez FJ, Bustamante J, Geigy N, Christ M, Di Somma S, Peacock WF, Cullen L, Sarasin F, Flores D, Tschuck M, Boeddinghaus J, Twerenbold R, Wildi K, Sabti Z, Puelacher C, Rubini Gimenez M, Kozhuharov N, Shrestha S, Strebel I, Rentsch K, Keller DI, Poepping I, Buser A, Kloos W, Lohrmann J, Kuehne M, Osswald S, Reichlin T, Mueller C. Prohormones in the Early Diagnosis of Cardiac Syncope. J Am Heart Assoc. 2017 Dec 14;6(12):e006592. doi: 10.1161/JAHA.117.006592.

  PMID: 29426039 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

EDTA Plasma; Heparin; Serum

MeSH Terms

Conditions

Syncope; Unconsciousness; Syncope, Vasovagal; Arrhythmias, Cardiac; Death, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Arrest; Death, Sudden; Death

Study Officials

• Christian Mueller, MD

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2012
• First Posted: March 8, 2012
• Study Start: April 1, 2010
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 15, 2025

Record last verified: 2025-04

Locations

US (1); ES (3); DE (1); IT (1); NZ (1); AR (1); CH (5); PL (1); AU (1)