BAsel Syncope EvaLuation (BASEL IX) Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University Hospital, Basel, Switzerland
Sponsor:
Collaborator:
Swiss National Science Foundation
Information provided by (Responsible Party):
Christian Müller, MD, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT01548352
First received: March 5, 2012
Last updated: January 16, 2013
Last verified: January 2013
  Purpose

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
Syncope

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: BAsel Syncope EvaLuation (BASEL IX) Study

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • diagnostic and prognostic value of various novel and established biomarkers, clinical assessment and detailed patient history [ Time Frame: within 24 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

EDTA Plasma; Heparin; Serum


Estimated Enrollment: 720
Study Start Date: April 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01548352

Contacts
Contact: Christian Mueller, MD 0041-61-2652525 chmueller@uhbs.ch

Locations
United States, Texas
Baylor College of Medicine Active, not recruiting
Houston, Texas, United States, 77030
Germany
Klinikum Nürnberg Recruiting
Nürnberg, Bavaria, Germany, 90419
Contact: Michael Christ, MD PhD    +49 911 398 2369    michael.christ@klinikum-nuernberg.de   
Principal Investigator: Michael Christ, MD         
Italy
Sant'Andrea Hospital Recruiting
Rome, Italy, 00189
Contact: Salvatore Di Somma, MD PhD    +39-(0)6 33775581    Salvatore.Disomma@uniroma1.it   
Sub-Investigator: Rossella Marino, MD         
Principal Investigator: Salvatore Di Somma, MD         
Spain
Hospital del Mar Recruiting
Barcelona, Spain, 08003
Contact: Joaquim Gea, MD    0034932483138    JGea@parcdesalutmar.cat   
Principal Investigator: Joaquim Gea, MD         
Sub-Investigator: Isabel Campodarve, MD         
Hospital Clinic of Barcelona Not yet recruiting
Barcelona, Spain, 08036
Contact: Oscar Miro, MD    0034-93 227 54 00    OMIRO@clinic.ub.es   
Principal Investigator: Oscar Miro, 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 Recruiting
Lachen, Schwyz, Switzerland, 8853
Contact: Stephan Steuer, MD    0041 55 45 13 111    stephan.steuer@spital-lachen.ch   
Principal Investigator: Stephan Steuer, MD         
University Hospital Basel Recruiting
Basel, Switzerland, 4031
Contact: Christian Mueller, MD    0041-61-2652525    chmueller@uhbs.ch   
Principal Investigator: Christian Mueller, MD         
Sub-Investigator: Miriam Reiter, MD         
Sub-Investigator: Berit Moehring, MD         
Sub-Investigator: Seoung Mann Sou, MD         
University Hospital Zurich Recruiting
Zurich, Switzerland, 8091
Contact: Albina Nowak, MD    +41-(0)44 255 24 30    Albina.Nowak@usz.ch   
Principal Investigator: Albina Nowak, MD         
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Swiss National Science Foundation
Investigators
Principal Investigator: Christian Mueller, MD University Hospital, Basel, Switzerland
  More Information

No publications provided

Responsible Party: Christian Müller, MD, Prof. Dr. med., University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01548352     History of Changes
Other Study ID Numbers: BASEL IX
Study First Received: March 5, 2012
Last Updated: January 16, 2013
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital, Basel, Switzerland:
Syncope
Unconsciousness
Syncope, vasovagal, neurally-mediated
Syncope, cardiogenic
Cardiac arrhythmia
Sudden cardiac death
Syncopal episode

Additional relevant MeSH terms:
Syncope
Consciousness Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Unconsciousness

ClinicalTrials.gov processed this record on October 30, 2014