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BAsel Syncope EvaLuation (BASEL IX) Study

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ClinicalTrials.gov Identifier: NCT01548352
Recruitment Status : Recruiting
First Posted : March 8, 2012
Last Update Posted : April 8, 2019
Sponsor:
Collaborator:
Swiss National Science Foundation
Information provided by (Responsible Party):
Christian Müller, MD, University Hospital, Basel, Switzerland

Tracking Information
First Submitted Date March 5, 2012
First Posted Date March 8, 2012
Last Update Posted Date April 8, 2019
Study Start Date April 2010
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 16, 2013)
diagnostic and prognostic value of various novel and established biomarkers, clinical assessment and detailed patient history [ Time Frame: within 24 months ]
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT01548352 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title BAsel Syncope EvaLuation (BASEL IX) Study
Official Title BAsel Syncope EvaLuation (BASEL IX) Study
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).

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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
EDTA Plasma; Heparin; Serum
Sampling Method Probability Sample
Study Population Patients presenting to the emergency department with syncope within the last 12 hours.
Condition Syncope
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 4, 2019)
3500
Original Estimated Enrollment
 (submitted: March 7, 2012)
720
Estimated Study Completion Date December 2022
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Christian Mueller, MD 0041-61-2652525 christian.mueller@usb.ch
Listed Location Countries Australia,   Belgium,   Czechia,   Germany,   Italy,   New Zealand,   Poland,   Spain,   Switzerland,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number NCT01548352
Other Study ID Numbers BASEL IX
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Christian Müller, MD, University Hospital, Basel, Switzerland
Study Sponsor University Hospital, Basel, Switzerland
Collaborators Swiss National Science Foundation
Investigators
Principal Investigator: Christian Mueller, MD University Hospital, Basel, Switzerland
PRS Account University Hospital, Basel, Switzerland
Verification Date April 2019