Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.


Condition or disease
Pulmonary Embolism 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.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 7000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Assessing the Risk of Pulmonary Embolism in Patients After Hospitalization for First Episode of Syncope
Estimated Study Start Date : February 1, 2017
Estimated Primary Completion Date : February 1, 2018
Estimated Study Completion Date : February 1, 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. venous thromboembolism [ Time Frame: 3 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)).
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.

Layout table for additonal information
Responsible Party: rambam71, MD, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT03034525     History of Changes
Other Study ID Numbers: 551-16-CTIL
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: January 27, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Pulmonary Embolism
Syncope
Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms