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Clinical and Laboratory Characteristics of Patients Admitted With Syncope; Diagnosis and Follow up After These Patients

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ClinicalTrials.gov Identifier: NCT01201993
Recruitment Status : Suspended
First Posted : September 15, 2010
Last Update Posted : June 21, 2011
Sponsor:
Information provided by:

Study Description
Brief 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.

Condition or disease
Diagnosis Recurrence

Detailed Description:
  1. 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.
  2. Assess physical and mental injury as a result of syncope.
  3. The lab workup will be documented including;

    1. - Routine blood tests.

      • troponin level.
    2. - ECG.

      • Echocardiogram
      • Brain CT.
      • EEG.
      • U/S doppler of carotids.
      • Tilt tests.
  4. At the time of diagnosis the final diagnosis will be documented including recommendations for patients to prevent syncope after discharge.
  5. Follow up after patients by phone verifying recurrence of syncope and resulting physical and or mental injury if any.

Study Design

Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Observational Study Following After Patients Admitted With Syncope
Study Start Date : August 2010
Estimated Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fainting
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. diagnosis [ Time Frame: 1 year ]
    Final diagnosis as a cause of syncope


Secondary Outcome Measures :
  1. 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.

  2. 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)

  3. 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.


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Admitted patients the medical ward
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01201993


Locations
Israel
Department of Medicine, Carmel Medical Center
Haifa, Israel, 34362
Sponsors and Collaborators
Carmel Medical Center
Investigators
Principal Investigator: George S Habib, M.D. Carmel Medical Center
More Information

Responsible Party: George S. Habib, Dept of Medicine, Carmel Medical Center
ClinicalTrials.gov Identifier: NCT01201993     History of Changes
Other Study ID Numbers: SYN2010
First Posted: September 15, 2010    Key Record Dates
Last Update Posted: June 21, 2011
Last Verified: September 2010

Keywords provided by Carmel Medical Center:
syncope
evaluation
recurrence
morbidity

Additional relevant MeSH terms:
Recurrence
Syncope
Disease Attributes
Pathologic Processes
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms