BAsel Syncope EvaLuation (BASEL IX) Study
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| ClinicalTrials.gov Identifier: NCT01548352 |
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Recruitment Status :
Active, not recruiting
First Posted : March 8, 2012
Last Update Posted : April 30, 2021
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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 |
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| Syncope |
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 |
| 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 2023 |
| Estimated Study Completion Date : | December 2023 |
- 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
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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 |
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
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
| United States, Texas | |
| Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
| Argentina | |
| Instituto Cardiovascular de Buenos Aires | |
| Buenos Aires, Argentina, C1428 | |
| Australia | |
| Royal Brisbane and Women's hospital | |
| Brisbane, Australia, QLD 4029 | |
| Germany | |
| Klinikum Nürnberg | |
| Nürnberg, Bavaria, Germany, 90419 | |
| Italy | |
| Sant'Andrea Hospital | |
| Rome, Italy, 00189 | |
| New Zealand | |
| Christchurch Hospital | |
| Christchurch, New Zealand | |
| Poland | |
| Medical University of Silesia | |
| Zabrze, Poland | |
| Spain | |
| Hospital del Mar | |
| Barcelona, Spain, 08003 | |
| Hospital Clinic of Barcelona | |
| Barcelona, Spain, 08036 | |
| Hospital Universitario Clínico San Carlos | |
| Madrid, Spain, 28040 | |
| Switzerland | |
| Kantonsspital Baselland | |
| Liestal, Baselland, Switzerland, 4410 | |
| Spital Lachen | |
| Lachen, Schwyz, Switzerland, 8853 | |
| University Hospital Basel | |
| Basel, Switzerland, 4031 | |
| Luzern Kantonsspital | |
| Luzern, Switzerland, 6000 | |
| University Hospital Zurich | |
| Zurich, Switzerland, 8091 | |
| Principal Investigator: | Christian Mueller, MD | University Hospital, Basel, Switzerland |
| 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: | April 30, 2021 |
| Last Verified: | April 2021 |
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Syncope Unconsciousness Syncope, vasovagal, neurally-mediated Syncope, cardiogenic |
Cardiac arrhythmia Sudden cardiac death Syncopal episode |
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Syncope Unconsciousness Consciousness Disorders |
Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases |