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Assessing the Risk of Pulmonary Embolism in Patients After Hospitalization for First Episode of Syncope

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ClinicalTrials.gov Identifier: NCT03034525
Recruitment Status : Unknown
Verified January 2017 by rambam71, Rambam Health Care Campus.
Recruitment status was:  Not yet recruiting
First Posted : January 27, 2017
Last Update Posted : January 27, 2017
Sponsor:
Information provided by (Responsible Party):
rambam71, Rambam Health Care Campus

Tracking Information
First Submitted Date January 25, 2017
First Posted Date January 27, 2017
Last Update Posted Date January 27, 2017
Estimated Study Start Date February 1, 2017
Estimated Primary Completion Date February 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 25, 2017)
venous thromboembolism [ Time Frame: 3 years ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Assessing the Risk of Pulmonary Embolism in Patients After Hospitalization for First Episode of Syncope
Official Title Assessing the Risk of Pulmonary Embolism in Patients After Hospitalization for First Episode of Syncope
Brief Summary

Acute pulmonary embolism (APE) is a common disease, which involves significant morbidity and mortality. The clinical presentation of APE has many faces but it is acceptable to suspect this disease when the patient presenting with at least one of the following: shortness of breath, pleuritic chest pain, cough, sub-febrile fever or hemoptysis.

The relationship between syncope and APE is not entirely clear. Prandoni et al conducted a systematic process for the exclusion / confirmation of APE all patients hospitalized for a first investigation of syncope. In this study APE was diagnosed in about 17% of the patients. In 12.7% of patients with an alternative explanation for syncope APE was diagnosed. Interestingly, 25% of the patients had no other manifestation of pulmonary embolism apart from the syncope itself.

According to the updated clinical guidelines, APE should not be routinely tested as an etiology for syncope and not systematically excluded. According to the new data presented by Prandoni et al, this means that a significant percentage of patients hospitalized for an investigation of syncope are discharged when they are suffering from APE (in most cases probably an event of unprovoked pulmonary embolism) without treatment with anticoagulants, making them particularly prone to PE recurrence.

Aim. To examine the incidence of pulmonary embolism (Pulmonary Embolism, PE), and VTE (venous thromboembolism, VTE) in patients hospitalized for a first investigation of syncope.

Detailed Description

Method.

Study population:

The study is a retrospective, multicenter cohort study, conducted at Rambam Health Care Campus and Sourasky Medical Center, Tel Aviv and includes all Clalit HMO insured patients who were admitted for investigation of first event of syncope from 2006 to 2013 (diagnosis on admission- syncope and collapse (ICD9 code 427.31)).

Inclusion criteria:

  • Patients over 18 years old during study period.
  • On admission diagnosis of syncope and collapse (ICD9 code 427.31).
  • Patients are insured by Clalit Health Services.

Exclusion criteria:

  • Hospitalization during the study period for additional event of syncope.
  • Patients receiving anticoagulation on recruitment.
  • Patients investigated for APE during hospitalization (by testing for D-dimer, computerized tomography angiography or perfusion-ventilation lung scan).
  • Patients who began treatment anticoagulation, not because of VTE, during study period.

Study design The research is divided into two main stages. At the first phase data of the relevant study population will be collected from the computerized medical record of the two medical centers mentioned above and according to the inclusion and exclusions criteria listed above.

In the second phase we will examine in the study population the occurrence of PE or DVT within 36 months from hospitalization.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The study is a retrospective, multicenter cohort study, conducted at Rambam Health Care Campus and Sourasky Medical Center, Tel Aviv and includes all Clalit HMO insured patients who were admitted for investigation of first event of syncope from 2006 to 2013 (diagnosis on admission- syncope and collapse (ICD9 code 427.31)).
Condition
  • Pulmonary Embolism
  • Syncope
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: January 25, 2017)
7000
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 1, 2018
Estimated Primary Completion Date February 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients over 18 years old during study period.

    * On admission diagnosis of syncope and collapse (ICD9 code 427.31).

  • Patients are insured by Clalit Health Services.

Exclusion Criteria:

* Hospitalization during the study period for additional event of syncope.

  • Patients receiving anticoagulation on recruitment.
  • Patients investigated for APE during hospitalization (by testing for D-dimer, computerized tomography angiography or perfusion-ventilation lung scan).
  • Patients who began treatment anticoagulation, not because of VTE, during study period.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03034525
Other Study ID Numbers 551-16-CTIL
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party rambam71, Rambam Health Care Campus
Study Sponsor Rambam Health Care Campus
Collaborators Not Provided
Investigators Not Provided
PRS Account Rambam Health Care Campus
Verification Date January 2017