Pulmonary EmbolismNCT03034525
Assessing the Risk of Pulmonary Embolism in Patients After Hospitalization for First Episode of Syncope
An observational study of Pulmonary Embolism and Syncope, run by Rambam Health Care Campus.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism, Syncope
- How many people
- 7,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2017to 1 Feb 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)).
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Pulmonary Embolism, Syncope
- Medical subject headings
- Pulmonary Embolism, Syncope
What is being measured
The primary outcome is the main question the study is designed to answer.
venous thromboembolism
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2017 (estimated)
- Study start1 Feb 2017 (estimated)
- Primary completion1 Feb 2018 (estimated)
- Study completion1 Feb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 7,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, rambam71, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03034525
- Sponsor's protocol ID
- 551-16-CTIL
- Status last verified
- Jan 2017
- First submitted
- 25 Jan 2017
- Last updated
- 27 Jan 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Risk of Pulmonary Embolism in Patients After Hospitalization for First Episode of Syncope
- ClinicalTrials.gov ID
- NCT03034525
- Acronym / sponsor ID
- 551-16-CTIL
- Conditions
- Pulmonary Embolism, Syncope
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 7,000 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 1 Feb 2017 (estimated)
- Primary completion
- 1 Feb 2018 (estimated)
- Study completion
- 1 Feb 2018 (estimated)
- First posted
- 27 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)).
Key inclusion criteria (3 listed)
- Patients over 18 years old during study period.
- Patients are insured by Clalit Health Services.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
venous thromboembolism
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Embolism and Syncope, run by Rambam Health Care Campus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
venous thromboembolism (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2017.