SyncopeE-STOPNCT00764985
Evaluation of Syncope,Its Diagnosis, Treatment, Outcome and Prognosis
An observational study of Syncope, run by St. Luke's-Roosevelt Hospital Center at 1 site in United States.
Trial summary
The investigators want to look at how patients admitted after passing out (syncope) or nearly passing out (pre-syncope) do after going home and how many of them remain free of symptoms of syncope or pre-syncope. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Syncope
- How many people
- 540 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Jul 2010
- 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: All patietns admitted to the adult medicine service at St. Luke's-Roosevelt Hospital with diagnossi of syncope or near syncope
Who may be able to join
- All adult patients (age 18 or older) admitted with syncope or near-syncope
Who cannot join
- Patients who do not speak/read the language of the consent form
- Prisoners
- Patients who are of altered mental status or had head trauma
- Refusal or inability to sign consent
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Luke's-Roosevelt Hospital Center
New York, New York, 10025
About this study
Official title: E-STOP Registry: A Registry for the Evaluation of Syncope,Its Diagnosis, Treatment, Outcome and Prognosis Using Our SELF-Pathway
The investigators want to look at how patients admitted after passing out (syncope) or nearly passing out (pre-syncope) do after going home and how many of them remain free of symptoms of syncope or pre-syncope.
- Conditions
- Syncope
- Keywords
- Syncope, Pre-Syncope, Fainting
- Medical subject headings
- Syncope
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 |
|---|---|---|
| Syncope | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2008 (estimated)
- Study startJun 2008
- Primary completionJul 2009
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Luke's-Roosevelt Hospital Center
- Sponsor type
- University, hospital or other
- Collaborators
- Transoma Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00764985
- Sponsor's protocol ID
- ESTOP-08-024
- Acronym
- E-STOP
- Status last verified
- Jul 2010
- First submitted
- 1 Oct 2008
- Last updated
- 2 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- E-STOP Registry: A Registry for the Evaluation of Syncope,Its Diagnosis, Treatment, Outcome and Prognosis Using Our SELF-Pathway
- ClinicalTrials.gov ID
- NCT00764985
- Acronym / sponsor ID
- E-STOP / ESTOP-08-024
- Conditions
- Syncope
- Keywords
- Syncope, Pre-Syncope, Fainting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- St. Luke's-Roosevelt Hospital CenterUniversity, hospital or other
- Collaborators
- Transoma Medical
- Study start
- Jun 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 2 Oct 2008 (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.
The investigators want to look at how patients admitted after passing out (syncope) or nearly passing out (pre-syncope) do after going home and how many of them remain free of symptoms of syncope or pre-syncope.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Syncope | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patietns admitted to the adult medicine service at St. Luke's-Roosevelt Hospital with diagnossi of syncope or near syncope
Key inclusion criteria (1 listed)
- All adult patients (age 18 or older) admitted with syncope or near-syncope
Key exclusion criteria (4 listed)
- Patients who do not speak/read the language of the consent form
- Prisoners
- Patients who are of altered mental status or had head trauma
- Refusal or inability to sign consent
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
Not reported in the source record.
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 2 Jul 2010.
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Head-to-Head (H2H) Comparison of Ambulatory Cardiac ECG Monitors in Japan
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Fainting Detection And Early Warning In Syncope Evaluation Study (ARISE)
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Syncope, run by St. Luke's-Roosevelt Hospital Center at 1 site in United States.
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 2 Jul 2010. 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 United States. 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.
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 2 Jul 2010.