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BAsel Syncope EvaLuation (BASEL IX) Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01548352
Recruitment Status : Recruiting
First Posted : March 8, 2012
Last Update Posted : November 22, 2019
Sponsor:
Collaborator:
Swiss National Science Foundation
Information provided by (Responsible Party):
Christian Müller, MD, University Hospital, Basel, Switzerland

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).


Condition or disease
Syncope

Detailed Description:

Background: Management of patients with syncope is a serious problem concerning 1-2% of emergency department (ED) visits. In 6-20% of these, syncope will be due to a cardiac origin. The rapid and accurate identification of these patients is an important unmet clinical need.

Aim: The aim of the study is to evaluate the diagnostic value of patient's history, clinical judgement and novel biomarkers, alone or in combination, in the diagnosis and risk stratification of patients > 40 years of age presenting with syncope to the ED.

Patients and Methods: This prospective, observational, international multicenter study is initially designed to enroll 720 adult patients > 40 years presenting to the ED with syncope within the last twelve hours. Patient history will be standardized using a predefined form. Treating physicians will be asked to quantify their clinical judgment regarding the presence of cardiac syncope. Digital 12-lead ECG will be recorded at presentation and stored electronically. Blood samples for the measurement of novel cardiovascular biomarkers (including copeptin, pro-endothelin-1, pro-adrenomedullin, natriuretic peptides and high-sensitive cardiac troponins) will be obtained at presentation and stored anonymized. 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) and results of follow-up examinations. The final diagnosis will be adjudicated by two independent experts after review of all documents pertaining to the individual patient after 6 months. The primary endpoint is to assess the performance of a standardized form of patient's history, clinical judgment and biomarkers, alone and in combination, in the diagnosis of a cardiac syncope, as adjudicated by two independent experts. Secondary endpoints include the accuracy of the above cited items in prognostic stratification and the determination of the cost-effectiveness of the best approach.

Clinical significance: A more accurate and more rapid diagnosis and risk stratification of cardiac syncope can significantly improve patient management and therefore reduce patient morbidity and treatment cost. Overall, we expect this study to provide novel insights, holding important scientific, clinical and economic implications.

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Study Type : Observational
Estimated Enrollment : 3500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: BAsel Syncope EvaLuation (BASEL IX) Study
Study Start Date : April 2010
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fainting




Primary Outcome Measures :
  1. Diagnostic and prognostic value of various novel and established biomarkers, clinical assessment and detailed patient history [ Time Frame: within 24 months ]
    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.


Biospecimen Retention:   Samples Without DNA
EDTA Plasma; Heparin; Serum


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients presenting to the emergency department with syncope within the last 12 hours.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01548352


Contacts
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Contact: Christian Mueller, MD 0041-61-2652525 christian.mueller@usb.ch

Locations
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United States, Texas
Baylor College of Medicine Active, not recruiting
Houston, Texas, United States, 77030
Argentina
Instituto Cardiovascular de Buenos Aires Recruiting
Buenos Aires, Argentina, C1428
Contact: Juan P Constable, MD         
Principal Investigator: Juan P Constable, MD         
Sub-Investigator: Alan Sigal, MD         
Australia
Royal Brisbane and Women's hospital Active, not recruiting
Brisbane, Australia, QLD 4029
Germany
Klinikum Nürnberg Completed
Nürnberg, Bavaria, Germany, 90419
Italy
Sant'Andrea Hospital Completed
Rome, Italy, 00189
New Zealand
Christchurch Hospital Recruiting
Christchurch, New Zealand
Contact: Than Martin, MD       martin@thanstedman.onmicrosoft.com   
Poland
Medical University of Silesia Recruiting
Zabrze, Poland
Contact: Beata Morawiec, MD         
Principal Investigator: Beata Morawiec, MD         
Spain
Hospital del Mar Active, not recruiting
Barcelona, Spain, 08003
Hospital Clinic of Barcelona Recruiting
Barcelona, Spain, 08036
Contact: Oscar Miro, MD    0034-93 227 54 00    OMIRO@clinic.ub.es   
Principal Investigator: Oscar Miro, MD         
Hospital Universitario Clínico San Carlos Recruiting
Madrid, Spain, 28040
Contact: Francisco J Martín, MD       fjjms@hotmail.com   
Principal Investigator: Francisco J Martín, MD         
Switzerland
Kantonsspital Baselland Recruiting
Liestal, Baselland, Switzerland, 4410
Contact: Nicolas Geigy, MD    0041 61 92 52 248    nicolas.geigy@ksli.ch   
Principal Investigator: Nicolas Geigy, MD         
Spital Lachen Active, not recruiting
Lachen, Schwyz, Switzerland, 8853
University Hospital Basel Active, not recruiting
Basel, Switzerland, 4031
Luzern Kantonsspital Recruiting
Luzern, Switzerland, 6000
Contact: Michael Christ, Prof.       michael.christ@luks.ch   
Principal Investigator: Michael Christ, Prof.         
University Hospital Zurich Recruiting
Zurich, Switzerland, 8091
Contact: Dagmar Keller, MD    +41-(0)44 255 24 30    Dagmar.Keller@usz.ch   
Principal Investigator: Dagmar Keller, MD         
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Swiss National Science Foundation
Investigators
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Principal Investigator: Christian Mueller, MD University Hospital, Basel, Switzerland

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
du Fay de Lavallaz J, Badertscher P, Nestelberger T, Isenrich R, Miró Ò, Salgado E, Geigy N, Christ M, Cullen L, Than M, Martin-Sanchez FJ, Bustamante Mandrión J, Di Somma S, Peacock WF, Kawecki D, Boeddinghaus J, Twerenbold R, Puelacher C, Wussler D, Strebel I, Keller DI, Poepping I, Kühne M, Mueller C, Reichlin T; BASEL IX Investigators, Giménez 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.

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Responsible Party: Christian Müller, MD, Prof. Dr. med., University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01548352    
Other Study ID Numbers: BASEL IX
First Posted: March 8, 2012    Key Record Dates
Last Update Posted: November 22, 2019
Last Verified: November 2019
Keywords provided by Christian Müller, MD, University Hospital, Basel, Switzerland:
Syncope
Unconsciousness
Syncope, vasovagal, neurally-mediated
Syncope, cardiogenic
Cardiac arrhythmia
Sudden cardiac death
Syncopal episode
Additional relevant MeSH terms:
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Syncope
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms