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

  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 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.

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

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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