DiagnosisNCT01201993
Clinical and Laboratory Characteristics of Patients Admitted With Syncope; Diagnosis and Follow up After These Patients
An observational study of Diagnosis and Recurrence, run by Carmel Medical Center at 1 site in Israel.
Trial summary
The investigators hypothesis is that a significant number of patients may remain without specific cause and have recurrent syncope with its associated physical and mental morbidity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diagnosis, Recurrence
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2010to Jun 2011
- 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: Admitted patients the medical ward
Who may be able to join
- patients with diagnosis of syncope on admission to the medical ward.
Who cannot join
- patients with loss of consciousness due to other than low perfusion of the brain
- patients that can't sign a consent form
- patients that we can't get details about the episode of the syncope
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study Following After Patients Admitted With Syncope
The investigators hypothesis is that a significant number of patients may remain without specific cause and have recurrent syncope with its associated physical and mental morbidity.
Read the detailed description
- Patients with diagnosis of syncope who were admitted to the medical ward will be interviewed and their charts reviewed to rule in or out the diagnosis of syncope.
- Assess physical and mental injury as a result of syncope.
- The lab workup will be documented including;
- - Routine blood tests.
- troponin level.
- - ECG.
- Echocardiogram
- Brain CT.
- EEG.
- U/S doppler of carotids.
- Tilt tests.
- At the time of diagnosis the final diagnosis will be documented including recommendations for patients to prevent syncope after discharge.
- Follow up after patients by phone verifying recurrence of syncope and resulting physical and or mental injury if any.
- Conditions
- Diagnosis, Recurrence
- Keywords
- syncope, evaluation, recurrence, morbidity
- Medical subject headings
- Disease, Recurrence, Syncope
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnosis
Final diagnosis as a cause of syncope
Measured: 1 year
Secondary outcomes (3)
recurrence
how many patients had recurrence of syncope and average number of syncope in these patients during the period of follow up of each patient.
Measured: 6 months
physical injury
During this period of follow up of each patient, was there a physical injury, graded either none, mild, moderate or severe (bedridden)
Measured: 6 months
Mental effect
fear of recurrent syncope affecting his mobility and graded from mild to severe where severe indicates fear of moving even one step without support.
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 posted15 Sep 2010 (estimated)
- Study startAug 2010
- Study completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiagnosisStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carmel Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- George S Habib, M.D., Principal investigator, Carmel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01201993
- Sponsor's protocol ID
- SYN2010
- Status last verified
- Sep 2010
- First submitted
- 17 Aug 2010
- Last updated
- 21 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study Following After Patients Admitted With Syncope
- ClinicalTrials.gov ID
- NCT01201993
- Acronym / sponsor ID
- SYN2010
- Conditions
- Diagnosis, Recurrence
- Keywords
- syncope, evaluation, recurrence, morbidity
- Study type
- Observational
- Recruitment status
- Suspended
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Carmel Medical CenterUniversity, hospital or other
- Study start
- Aug 2010
- Study completion
- Jun 2011 (estimated)
- First posted
- 15 Sep 2010 (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 hypothesis is that a significant number of patients may remain without specific cause and have recurrent syncope with its associated physical and mental morbidity.
Detailed description
- Patients with diagnosis of syncope who were admitted to the medical ward will be interviewed and their charts reviewed to rule in or out the diagnosis of syncope.
- Assess physical and mental injury as a result of syncope.
- The lab workup will be documented including;
- - Routine blood tests.
- troponin level.
- - ECG.
- Echocardiogram
- Brain CT.
- EEG.
- U/S doppler of carotids.
- Tilt tests.
- At the time of diagnosis the final diagnosis will be documented including recommendations for patients to prevent syncope after discharge.
- Follow up after patients by phone verifying recurrence of syncope and resulting physical and or mental injury if any.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Admitted patients the medical ward
Key inclusion criteria (1 listed)
- patients with diagnosis of syncope on admission to the medical ward.
Key exclusion criteria (3 listed)
- patients with loss of consciousness due to other than low perfusion of the brain
- patients that can't sign a consent form
- patients that we can't get details about the episode of the syncope
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
diagnosis
Time frame: 1 year
Final diagnosis as a cause of syncope
3 secondary outcomes
recurrence
Time frame: 6 months
physical injury
Time frame: 6 months
Mental effect
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2011.
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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.
George S Habib, M.D. principal investigator
Carmel Medical Center
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 Diagnosis and Recurrence, run by Carmel Medical Center at 1 site in Israel.
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 3 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: paused, as of the sponsor's last update on 21 Jun 2011. 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 Israel. 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?
Results are not available in the source record.
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?
diagnosis (time frame: 1 year). 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 21 Jun 2011.