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

This study has suspended participant recruitment.
Sponsor:
Information provided by:
Carmel Medical Center
ClinicalTrials.gov Identifier:
NCT01201993
First received: August 17, 2010
Last updated: June 19, 2011
Last verified: September 2010
History of Changes
  Purpose

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
Diagnosis
Recurrence

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Observational Study Following After Patients Admitted With Syncope

Resource links provided by NLM:

MedlinePlus related topics: Fainting
U.S. FDA Resources

Further study details as provided by Carmel Medical Center:

Primary Outcome Measures:
  • diagnosis [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Final diagnosis as a cause of syncope


Secondary Outcome Measures:
  • recurrence [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    how many patients had recurrence of syncope and average number of syncope in these patients during the period of follow up of each patient.

  • physical injury [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    During this period of follow up of each patient, was there a physical injury, graded either none, mild, moderate or severe (bedridden)

  • Mental effect [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    fear of recurrent syncope affecting his mobility and graded from mild to severe where severe indicates fear of moving even one step without support.


Estimated Enrollment: 40
Study Start Date: August 2010
Estimated Study Completion Date: June 2011
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: George S. Habib, Dept of Medicine, Carmel Medical Center
ClinicalTrials.gov Identifier: NCT01201993     History of Changes
Other Study ID Numbers: SYN2010
Study First Received: August 17, 2010
Last Updated: June 19, 2011
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on May 22, 2013