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

Recurrence Clinical Trial

Official title:

Observational Study Following After Patients Admitted With Syncope

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01201993
• Other study ID #: SYN2010
• Status: Suspended
• Phase: N/A
• First received: August 17, 2010
• Last updated: June 19, 2011
• Start date: August 2010
• Est. completion date: June 2011

Study information

• Verified date: September 2010
• Source: Carmel Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 40
• Est. completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diagnosis
• Recurrence
• Syncope

Locations

Country	Name	City	State
Israel	Department of Medicine, Carmel Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Carmel Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	diagnosis	Final diagnosis as a cause of syncope	1 year	No
Secondary	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.	6 months	No
Secondary	physical injury	During this period of follow up of each patient, was there a physical injury, graded either none, mild, moderate or severe (bedridden)	6 months	Yes
Secondary	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.	6 months	Yes