Pulmonary EmbolismPEDISNCT04454554
Prevalence of Pulmonary Embolism in Patients With Dyspnea on Exertion (PEDIS)
An observational study of Pulmonary Embolism, run by Arianna Anticoagulazione Foundation at 1 site in Italy.
Trial summary
PEDIS Study is an observational, cross-sectional, multicenter Italian study conducted in a consecutive series of patients who refer to the Emergency Departments (either spontaneously or sent by their attending physicians) for the recent (less than one months) development of exertional dyspnea. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pulmonary Embolism
- How many people
- 400 participants
- Where
- 1 siteItaly
- Study dates
- 24 Sep 2018to 30 Jan 2021
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive patients who refer to the Emergency Departments of the participating centers will be eligible for the study provided they are older than 18 and younger than 75 years, and have developed one or more episodes of exertional dyspnea since less than one month.
Who may be able to join
- Age older than 18 and younger than 75
- Recent (less than one month) development of exertional dyspnea
- Able to provide informed consent
Who cannot join
- Anticoagulation required for other indications
- Contraindication to CT angiography (allergy to the contrast dye, severe renal failure [creatinine clearance < 30 ml/min])
- Involvement in simultaneous clinical trials
- Unable to provide their written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Pulmonary Embolism (PE) Among Patients Referred to Emergency Departments for Dyspnea on Exertion
PEDIS Study is an observational, cross-sectional, multicenter Italian study conducted in a consecutive series of patients who refer to the Emergency Departments (either spontaneously or sent by their attending physicians) for the recent (less than one months) development of exertional dyspnea.
The general aim of the study is to assess the prevalence of PE in the overall population referring to the Emergency Departments without potential explanations for dyspnea
Read the detailed description
PEDIS Study is an observational, cross-sectional, multicenter and no Profit Study.
600 consecutive patients referring to the Emergency Departments of the participating centers because they have developed one or more episodes of exertional dyspnea since less than one month will be enrolled. All eligible patients will be interviewed and examined by trained study physicians. The presence of already known potential explanations for the dyspnea will be assessed. In addition, symptoms of the lower extremities will be elicited, as well as the presence of risk factors for venous thromboembolism (VTE).
The presence or absence of pulmonary embolism will be assessed with the use of a validated algorithm based on pre-test clinical probability and D-dimer result. In patients in whom the pre-test clinical probability is low and the D-dimer result is negative, no further testing will be done, and PE will be considered excluded. In patients with high clinical probability, positive D-dimer result, or both, computed tomography (CT) pulmonary angiography will be performed
The primary study objective is to evaluate Prevalence of PE in the overall population
- Conditions
- Pulmonary Embolism
- Keywords
- Dyspnea, Pulmonary embolism
- Medical subject headings
- Pulmonary Embolism, Dyspnea
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of PE in the overall population
Prevalence of Pulmonary Embolism in patient with high pre-test clinical probability and/or positive D-dimer without potential explanations for the dyspnea who underwent computed tomography pulmonary angiography
Measured: From the first day of enrollment up to 104 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study start24 Sep 2018
- Primary completion24 Dec 2020
- Study completion30 Jan 2021
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 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arianna Anticoagulazione Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlo Bova, MD, Study director, Azienda Ospedaliera di Cosenza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04454554
- Sponsor's protocol ID
- FAA O4 5-2018 (PEDIS)
- Acronym
- PEDIS
- Status last verified
- Mar 2021
- First submitted
- 26 Jun 2020
- Last updated
- 19 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Prandoni P, Lensing AWA, Prins MH, Ciammaichella M, Pirillo S, Pace F, Zalunardo B, Bottino F, Ageno W, Muiesan ML, Forlin M, Depietri L, Bova C, Costantini N, Caviglioli C, Migliaccio L, Noventa F, Levi M, Davidson BL, Palareti G; Pulmonary Embolism Dyspnea Italian Study (PEDIS) Investigators. Prevalence of pulmonary embolism among patients with recent onset of dyspnea on exertion. A cross-sectional study. J Thromb Haemost. 2023 Jan;21(1):68-75. doi: 10.1016/j.jtha.2022.09.007. Epub 2022 Dec 22.
PubMed 36695397
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Pulmonary Embolism (PE) Among Patients Referred to Emergency Departments for Dyspnea on Exertion
- ClinicalTrials.gov ID
- NCT04454554
- Acronym / sponsor ID
- PEDIS / FAA O4 5-2018 (PEDIS)
- Conditions
- Pulmonary Embolism
- Keywords
- Dyspnea, Pulmonary embolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Arianna Anticoagulazione FoundationUniversity, hospital or other
- Study start
- 24 Sep 2018 (actual)
- Primary completion
- 24 Dec 2020 (actual)
- Study completion
- 30 Jan 2021 (actual)
- First posted
- 1 Jul 2020 (actual)
- 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.
PEDIS Study is an observational, cross-sectional, multicenter Italian study conducted in a consecutive series of patients who refer to the Emergency Departments (either spontaneously or sent by their attending physicians) for the recent (less than one months) development of exertional dyspnea.
The general aim of the study is to assess the prevalence of PE in the overall population referring to the Emergency Departments without potential explanations for dyspnea
Detailed description
PEDIS Study is an observational, cross-sectional, multicenter and no Profit Study.
600 consecutive patients referring to the Emergency Departments of the participating centers because they have developed one or more episodes of exertional dyspnea since less than one month will be enrolled. All eligible patients will be interviewed and examined by trained study physicians. The presence of already known potential explanations for the dyspnea will be assessed. In addition, symptoms of the lower extremities will be elicited, as well as the presence of risk factors for venous thromboembolism (VTE).
The presence or absence of pulmonary embolism will be assessed with the use of a validated algorithm based on pre-test clinical probability and D-dimer result. In patients in whom the pre-test clinical probability is low and the D-dimer result is negative, no further testing will be done, and PE will be considered excluded. In patients with high clinical probability, positive D-dimer result, or both, computed tomography (CT) pulmonary angiography will be performed
The primary study objective is to evaluate Prevalence of PE in the overall population
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients who refer to the Emergency Departments of the participating centers will be eligible for the study provided they are older than 18 and younger than 75 years, and have developed one or more episodes of exertional dyspnea since less than one month.
Key inclusion criteria (3 listed)
- Age older than 18 and younger than 75
- Recent (less than one month) development of exertional dyspnea
- Able to provide informed consent
Key exclusion criteria (4 listed)
- Anticoagulation required for other indications
- Contraindication to CT angiography (allergy to the contrast dye, severe renal failure [creatinine clearance < 30 ml/min])
- Involvement in simultaneous clinical trials
- Unable to provide their written informed consent
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
Prevalence of PE in the overall population
Time frame: From the first day of enrollment up to 104 weeks
Prevalence of Pulmonary Embolism in patient with high pre-test clinical probability and/or positive D-dimer without potential explanations for the dyspnea who underwent computed tomography pulmonary angiography
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 19 Mar 2021.
- Derived from this study: PubMed 36695397Prandoni P, Lensing AWA, Prins MH, Ciammaichella M, Pirillo S, Pace F, Zalunardo B, Bottino F, Ageno W, Muiesan ML, Forlin M, Depietri L, Bova C, Costantini N, Caviglioli C, Migliaccio L, Noventa F, Levi M, Davidson BL, Palareti G; Pulmonary Embolism Dyspnea Italian Study (PEDIS) Investigators. Prevalence of pulmonary embolism among patients with recent onset of dyspnea on exertion. A cross-sectional study. J Thromb Haemost. 2023 Jan;21(1):68-75. doi: 10.1016/j.jtha.2022.09.007. Epub 2022 Dec 22.
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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.
Carlo Bova, MD study director
Azienda Ospedaliera di Cosenza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Embolism, run by Arianna Anticoagulazione Foundation 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 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: finished, as of the sponsor's last update on 19 Mar 2021. 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?
Prevalence of PE in the overall population (time frame: From the first day of enrollment up to 104 weeks). 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 NCT04454554, 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 19 Mar 2021.