(Near) SyncopeNCT01916070
Syncope Patient Evaluation in the Emergency Department
An observational study of (Near) Syncope, run by Klinikum Nürnberg at 1 site in Germany.
Trial summary
Patients with the symptom complex syncope or near-syncope are quite often in the emergency department. Most patients with syncope have a positive prognosis. However some types of syncope are associated with an increased morbidity and mortality. It is a challenge to detect these patients reliably at an early stage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- (Near) Syncope
- How many people
- 397 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2011to May 2012
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients presenting with (near) syncope to the emergency department
Who may be able to join
- (near) syncope
Who cannot join
- age < 18 years
- progressive impairment of consciousness
- use of mind-altering drugs
- non syncopal loss of consciousness: hyperventilation, hypoglycaemia, metabolic disorders, psychogenic pseudosyncope, TIA or stroke, seizure, transient loss of consciousness caused by craniocerebral injury
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Syncope Patient Evaluation in the Emergency Department (SPEED)
Patients with the symptom complex syncope or near-syncope are quite often in the emergency department. Most patients with syncope have a positive prognosis. However some types of syncope are associated with an increased morbidity and mortality. It is a challenge to detect these patients reliably at an early stage. The current guidelines contain exact definitions concerning the characteristics of patients with syncope and recommendations on how to diagnose and treat these patients following standardized pathways. Due to the fact that near-syncope is poorly defined and therefore seldom evaluated in clinical trials, data concerning near-syncope are rare.
Our aim was to characterize patients presenting with syncope or near-syncope to the emergency department regarding their risk profile, comorbidities and prognosis. First we evaluated if there is a difference between the two groups syncope and near-syncope concerning type and frequency of adverse events. Furthermore we analyzed the routinely measured cardiac biomarkers NT-proBNP and hs cTnT in patients with syncope or near-syncope. Then we determined both their prognostic accuracy in predicting adverse events and their diagnostic accuracy in finding the underlying etiology. Finally we analyzed a special patient collective, patients aged ≥ 65 years. It is assumed that elderly patients are suffering from comorbidities and age-related physiological and cognitive disabilities. We therefore hypothesize that elderly patients, in contrast to patients aged < 60, display an increased risk of adverse events and that they have a poorer prognosis.
- Conditions
- (Near) Syncope
- Keywords
- syncope, near syncope, prognosis, emergency department
- Medical subject headings
- Syncope, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients with syncope | Not described | |
| patients with near syncope | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
adverse events in patients with syncope and near syncope within 30 days after presentation to the emergency department
Measured: 30 days
Secondary outcomes (3)
prevalence and prognosis of patients with syncope or near syncope in the emergency department
Measured: 6 months
prognostic and diagnostic accuracy of cardiac biomarkers NTproBNP and hs-cTnT
Measured: 6 months
prevalence, prognosis and clinical assessment of elderly patients ≥ 65 years with (near) syncope in the emergency department
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2013 (estimated)
- Study startJul 2011
- Primary completionNov 2011
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for (Near) SyncopeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 397 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Klinikum Nürnberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Michael Christ, Klinikum Nürnberg
- Investigators
- Michael Christ, Prof., Principal investigator, Klinikum Nürnberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01916070
- Sponsor's protocol ID
- SPEED01
- Status last verified
- Aug 2013
- First submitted
- 2 Aug 2013
- Last updated
- 5 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Syncope Patient Evaluation in the Emergency Department (SPEED)
- ClinicalTrials.gov ID
- NCT01916070
- Acronym / sponsor ID
- SPEED01
- Conditions
- (Near) Syncope
- Keywords
- syncope, near syncope, prognosis, emergency department
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 397 participants (actual)
- Lead sponsor
- Klinikum NürnbergUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 5 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with the symptom complex syncope or near-syncope are quite often in the emergency department. Most patients with syncope have a positive prognosis. However some types of syncope are associated with an increased morbidity and mortality. It is a challenge to detect these patients reliably at an early stage. The current guidelines contain exact definitions concerning the characteristics of patients with syncope and recommendations on how to diagnose and treat these patients following standardized pathways. Due to the fact that near-syncope is poorly defined and therefore seldom evaluated in clinical trials, data concerning near-syncope are rare.
Our aim was to characterize patients presenting with syncope or near-syncope to the emergency department regarding their risk profile, comorbidities and prognosis. First we evaluated if there is a difference between the two groups syncope and near-syncope concerning type and frequency of adverse events. Furthermore we analyzed the routinely measured cardiac biomarkers NT-proBNP and hs cTnT in patients with syncope or near-syncope. Then we determined both their prognostic accuracy in predicting adverse events and their diagnostic accuracy in finding the underlying etiology. Finally we analyzed a special patient collective, patients aged ≥ 65 years. It is assumed that elderly patients are suffering from comorbidities and age-related physiological and cognitive disabilities. We therefore hypothesize that elderly patients, in contrast to patients aged < 60, display an increased risk of adverse events and that they have a poorer prognosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with syncope | – | – |
| patients with near syncope | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients presenting with (near) syncope to the emergency department
Key inclusion criteria (1 listed)
- (near) syncope
Key exclusion criteria (4 listed)
- age < 18 years
- progressive impairment of consciousness
- use of mind-altering drugs
- non syncopal loss of consciousness: hyperventilation, hypoglycaemia, metabolic disorders, psychogenic pseudosyncope, TIA or stroke, seizure, transient loss of consciousness caused by craniocerebral injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
adverse events in patients with syncope and near syncope within 30 days after presentation to the emergency department
Time frame: 30 days
3 secondary outcomes
prevalence and prognosis of patients with syncope or near syncope in the emergency department
Time frame: 6 months
prognostic and diagnostic accuracy of cardiac biomarkers NTproBNP and hs-cTnT
Time frame: 6 months
prevalence, prognosis and clinical assessment of elderly patients ≥ 65 years with (near) syncope in the emergency department
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Christ, Prof. principal investigator
Klinikum Nürnberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of (Near) Syncope, run by Klinikum Nürnberg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adverse events in patients with syncope and near syncope within 30 days after presentation to the emergency department (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2013.