Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT01548352 |
| Other study ID # |
BASEL IX |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 2010 |
| Est. completion date |
December 2023 |
Study information
| Verified date |
April 2021 |
| Source |
University Hospital, Basel, Switzerland |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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).
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.
