- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01201993
Clinical and Laboratory Characteristics of Patients Admitted With Syncope; Diagnosis and Follow up After These Patients
June 19, 2011 updated by: Carmel Medical Center
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.
Study Overview
Status
Suspended
Conditions
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 Type
Observational
Enrollment (Anticipated)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Haifa, Israel, 34362
- Department of Medicine, Carmel Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Admitted patients the medical ward
Description
Inclusion Criteria:
- patients with diagnosis of syncope on admission to the medical ward.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
diagnosis
Time Frame: 1 year
|
Final diagnosis as a cause of syncope
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
recurrence
Time Frame: 6 months
|
how many patients had recurrence of syncope and average number of syncope in these patients during the period of follow up of each patient.
|
6 months
|
|
physical injury
Time Frame: 6 months
|
During this period of follow up of each patient, was there a physical injury, graded either none, mild, moderate or severe (bedridden)
|
6 months
|
|
Mental effect
Time Frame: 6 months
|
fear of recurrent syncope affecting his mobility and graded from mild to severe where severe indicates fear of moving even one step without support.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: George S Habib, M.D., Carmel Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2010
Study Completion (Anticipated)
June 1, 2011
Study Registration Dates
First Submitted
August 17, 2010
First Submitted That Met QC Criteria
September 14, 2010
First Posted (Estimate)
September 15, 2010
Study Record Updates
Last Update Posted (Estimate)
June 21, 2011
Last Update Submitted That Met QC Criteria
June 19, 2011
Last Verified
September 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SYN2010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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