SyncopePESYNCT01797289
Prevalence of Pulmonary Embolism in Patients With Syncope
A study testing Lung CT or V/Q scanning in patients with a high pre-test clinical probability of PE and/or a positive D-dimer in people with Syncope and Pulmonary Embolism, run by University of Padova at 1 site in Italy.
Trial summary
All patients consecutively referred with the first episode of transient and short-lasting loss of consciousness will have a diagnostic workup for the assessment of the most common causes of syncope, and will be evaluated for the presence of pulmonary embolism (PE) with the use of an internationally accepted algorithm… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Syncope, Pulmonary Embolism
- What is being tested?
- Lung CT or V/Q scanning in patients with a high pre-test clinical probability of PE and/or a positive D-dimer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2012to Oct 2014
- Phase
- Interventional
- 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
Who may be able to join
- first episode of syncope
Who cannot join
- previous episodes of syncope
- ongoing anticoagulation
- age younger than 18 years
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Prevalence of Pulmonarym Embolism in Patients With the First Episode of Syncope
All patients consecutively referred with the first episode of transient and short-lasting loss of consciousness will have a diagnostic workup for the assessment of the most common causes of syncope, and will be evaluated for the presence of pulmonary embolism (PE) with the use of an internationally accepted algorithm including a pre-test clinical probability (PTP according to the method of Wells et al.) and a high-sensitivity quantitative D-dimer assay. If the PTP is low and D-dimer negative, PE will be excluded. All other patients will undergo confirmatory diagnostic tests (either computerized tomography or ventilation/perfusion lung scanning) in order to confirm or rule out the presence of PE.
- Conditions
- Syncope, Pulmonary Embolism
- Being tested
- Lung CT or V/Q scanning in patients with a high pre-test clinical probability of PE and/or a positive D-dimer
- Keywords
- syncope, pulmonary embolism
- Medical subject headings
- Syncope, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung CT or V/Q scanning in patients with a high pre-test clinical probability of PE and/or a positive D-dimerOther
| Study group | Role | What they receive |
|---|---|---|
| First episode of loss of consciousness | Experimental | Not described Receives: Other: Lung CT or V/Q scanning in patients with a high pre-test clinical probability of PE and/or a positive D-dimer |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the prevalence of PE in a large series of consecutive patients presenting with the first episode of syncope
Measured: Up to 48 hours after hospital admission
Secondary outcomes (1)
To assess the prevalence of pulmonary embolism in patients with apparently unexplained syncope
Measured: Up to one week after hospital admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2013 (estimated)
- Study startFeb 2012
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SyncopeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo Prandoni, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01797289
- Sponsor's protocol ID
- 52823P
- Acronym
- PESY
- Status last verified
- Jan 2015
- First submitted
- 20 Feb 2013
- Last updated
- 26 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Prandoni P, Lensing AW, Prins MH, Ciammaichella M, Perlati M, Mumoli N, Bucherini E, Visona A, Bova C, Imberti D, Campostrini S, Barbar S; PESIT Investigators. Prevalence of Pulmonary Embolism among Patients Hospitalized for Syncope. N Engl J Med. 2016 Oct 20;375(16):1524-1531. doi: 10.1056/NEJMoa1602172.
PubMed 27797317
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence of Pulmonarym Embolism in Patients With the First Episode of Syncope
- ClinicalTrials.gov ID
- NCT01797289
- Acronym / sponsor ID
- PESY / 52823P
- Conditions
- Syncope, Pulmonary Embolism
- Keywords
- syncope, pulmonary embolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 22 Feb 2013 (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.
All patients consecutively referred with the first episode of transient and short-lasting loss of consciousness will have a diagnostic workup for the assessment of the most common causes of syncope, and will be evaluated for the presence of pulmonary embolism (PE) with the use of an internationally accepted algorithm including a pre-test clinical probability (PTP according to the method of Wells et al.) and a high-sensitivity quantitative D-dimer assay. If the PTP is low and D-dimer negative, PE will be excluded. All other patients will undergo confirmatory diagnostic tests (either computerized tomography or ventilation/perfusion lung scanning) in order to confirm or rule out the presence of PE.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| First episode of loss of consciousness | Experimental | Other: Lung CT or V/Q scanning in patients with a high pre-test clinical probability of PE and/or a positive D-dimer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- first episode of syncope
Key exclusion criteria (4 listed)
- previous episodes of syncope
- ongoing anticoagulation
- age younger than 18 years
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lung CT or V/Q scanning in patients with a high pre-test clinical probability of PE and/or a positive D-dimer | Other | First episode of loss of consciousness |
Primary outcome
To assess the prevalence of PE in a large series of consecutive patients presenting with the first episode of syncope
Time frame: Up to 48 hours after hospital admission
1 secondary outcome
To assess the prevalence of pulmonary embolism in patients with apparently unexplained syncope
Time frame: Up to one week after hospital admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2015.
- Derived from this study: PubMed 27797317Prandoni P, Lensing AW, Prins MH, Ciammaichella M, Perlati M, Mumoli N, Bucherini E, Visona A, Bova C, Imberti D, Campostrini S, Barbar S; PESIT Investigators. Prevalence of Pulmonary Embolism among Patients Hospitalized for Syncope. N Engl J Med. 2016 Oct 20;375(16):1524-1531. doi: 10.1056/NEJMoa1602172.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lung CT or V/Q scanning in patients with a high pre-test clinical probability of PE and/or a positive D-dimer in people with Syncope and Pulmonary Embolism, run by University of Padova at 1 site in Italy.
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 1 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: finished, as of the sponsor's last update on 26 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To assess the prevalence of PE in a large series of consecutive patients presenting with the first episode of syncope (time frame: Up to 48 hours after hospital admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01797289, which also lists 1 linked publication.
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 26 Jan 2015.