Clinical and Laboratory Characteristics of Patients Admit... | NCT01201993

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

NCT01201993

Sponsor

Carmel Medical Center

Status

Suspended

Last Update Posted

Jun 21, 2011Estimated

Enrollment

40Estimated

Phase

Not provided

Conditions

Diagnosis
Recurrence

Interventions

Not provided

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2010

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2010

Primary Completion Date

Not provided

Completion Date

Jun 2011Estimated

First Submitted Date

Aug 17, 2010

First Submission Date that Met QC Criteria

Sep 14, 2010

First Posted Date

Sep 15, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 19, 2011

Last Update Posted Date

Jun 21, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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;
1. - Routine blood tests.
  - troponin level.
2. - 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
diagnosis	Final diagnosis as a cause of syncope	1 year

Secondary Outcomes

Measure	Description	Time Frame
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
physical injury	During this period of follow up of each patient, was there a physical injury, graded either none, mild, moderate or severe (bedridden)

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Admitted patients the medical ward

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
George S Habib, M.D.	Carmel Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Medicine, Carmel Medical Center		Haifa		34362	Israel

Condition Browse Module

MeSH Terms

ID	Term
D004194	Disease
D012008	Recurrence
D013575	Syncope

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D020969	Disease Attributes
D014474	Unconsciousness

Browse Leaves

Not provided

Browse Branches

Not provided