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Pulmonary EmbolismSPEED&PEPSNCT06015529

Diagnostic Strategy for Suspected Pulmonary Embolism Based on 4PEPS

A study testing 4PEPS strategy in people with Pulmonary Embolism, run by University Hospital, Angers at 23 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The increased use of diagnostic imaging and especially computed tomography pulmonary angiography in patients suspected of pulmonary embolism (PE) is an important point of concerns. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pulmonary Embolism
What is being tested?
4PEPS strategy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,084 participants
Where
23 sitesin 2 countries
Study dates
29 Nov 2023to 10 Nov 2025
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

  • Admission to an emergency department participating in the study.
  • Suspected PE due to thoracic symptoms (dyspnea, chest pain, or hemoptysis) and/or syncope without any other obvious explanation after clinical examination and possible additional first-line tests (ECG, chest X-ray, or routine lab work-up).

Who cannot join

  • Age < 18 years.
  • Known result of a specific diagnostic imaging examination for PE (thoracic CT angiography, pulmonary scintigraphy, or venous ultrasound of the lower limbs).
  • Hemodynamic instability (systolic blood pressure < 90 mmHg or more than 40 mmHg lower than usual for more than 15 min).
  • Curative dose of anticoagulant in place for more than two days prior to inclusion.
  • Pregnant or parturient patient.
  • Patient in detention by judicial or administrative decision.
Show all 9Show fewer
  • Patient undergoing compulsory psychiatric treatment.
  • Patient placed under a legal protection measure.
  • Patient who objects to participating in the research (preliminary phase) or is unable to give free and informed consent (active phase).

Trial locations and contacts

23 sites in 2 countries.

23 sites in 2 countries

France21 sites

  • CH Agen

    Agen

  • CHU Angers

    Angers, 49000

  • CH Argenteuil

    Argenteuil

  • CH Arpajon

    Arpajon

  • AP HP Clamart

    Clamart

  • CHU Clermont Ferrand

    Clermont-Ferrand

  • CHU Grenoble

    Grenoble

  • CH La Rochelle

    La Rochelle

  • CH Versailles

    Le Chesnay

  • CHU Limoges

    Limoges

  • CHU Lyon

    Lyon

  • CHR Metz Thionville

    Metz

  • CHU Nantes

    Nantes

  • CHU Nice

    Nice

  • GH Paris

    Paris

  • CHU Poitiers

    Poitiers

  • CH Rochefort

    Rochefort

  • CHU Rouen

    Rouen

  • CHU Toulouse

    Toulouse

  • CHU Tours

    Tours

  • CH Troyes

    Troyes

Other trials in France

Belgium2 sites

  • Cliniques Bruxelles

    Brussels

  • CHU Liège

    Liège

Other trials in Belgium

About this study

Official title: Diagnostic Strategy for Suspected Pulmonary Embolism in Emergency Departments Based on the 4-Level Pulmonary Embolism Clinical Probability Score: SPEED&PEPS Trial

The increased use of diagnostic imaging and especially computed tomography pulmonary angiography in patients suspected of pulmonary embolism (PE) is an important point of concerns.

The goal of this pragmatic cluster-randomized trial is to compare the diagnostic strategy based on the four-level pulmonary embolism probability score (4PEPS) and current practices.

The main questions it aims to answer is: "Does the diagnostic strategy based on 4PEPS significantly reduce the use of thoracic imaging without increasing the risk of serious adverse events as compared to current diagnostic practices?" Patients suspected of having PE in the participating emergency departments will be included and followed for 90 days. In ten centers, the emergency physicians will apply the 4PEPS strategy and in ten other centers, the emergency physicians will be free to do as they see fit. Researchers will compare the two groups of patients to see if the rate of diagnostic thoracic imaging tests and the rate of adverse events related to diagnostic strategies will differ.

Read the detailed description

Several strategies have been devised to safely limit the use of thoracic imaging in patients suspected of pulmonary embolism (PE). However, they are based on different rules for clinical probability (CP) assessment, rendering their combination difficult. The four-level pulmonary embolism probability score (4PEPS) allows the combination of all other strategies using a single CP assessment. Methods and analysis: SPEED\&PEPS is a pragmatic cluster-randomized trial. After a preliminary period aimed to assess the possibility of inclusions and current practices in 23 Emergency Departments (ED), 20 EDs will be selected to participate to the active phase and randomization. Half of the centers will be allocated to the control group where physicians will be free to do as they see fit but they will be given the recommendation to apply a validated strategy. Half of the centers will be allocated to the interventional group where the physicians will be given the recommendation to apply the 4PEPS strategy. Patients with suspected PE will be included and followed for 90 days (anticipated number of patients to be included: 2560, 1280 in each arm). The primary objective will be to demonstrate that the application of the 4PEPS strategy by emergency physicians, in comparison to current practices, (i) does not increase the risk of serious events related to diagnostic strategies and (ii) significantly reduces the use of thoracic imaging. If successful, the SPEED\&PEPS trial will have an important impact for patients suspected of PE limiting their irradiation and for public health in substantial savings in terms of the direct cost of diagnostic investigations and the indirect cost of hospitalizations due to waiting times or delayed harmful effects. Funding: This work is funded by a French Public Health grant (PREPS-N 2019). The funding source plays no role in the study design, data collection, analysis, interpretation or the writing of the manuscript.

Being tested
4PEPS strategy
Keywords
Pulmonary Embolism, suspected PE, diagnostic strategy, clinical probability, cluster-randomized trial
Medical subject headings
Pulmonary Embolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 4PEPS strategyDiagnostic test

    Physicians of the participating centers in the intervention group will have the recommendation to apply the 4PEPS strategy. Using 12 variables, 4PEPS defines four levels of CP that rule out a PE, namely

    1. based only on clinical data (very low CP: PEPS < 0),
    2. based on a D-dimer level < 1000 μg/L (low CP: PEPS ≥ 0 and < 5),
    3. based on a D-dimer level with an age-adjusted cut-off value (moderate CP: PEPS ≥ 5 and <12), or
    4. the diagnosis cannot reliably be ruled out based on a D-dimer test (high CP: PEPS ≥ 12)
Study groups in NCT06015529
Study groupRoleWhat they receive
Control group - current practicesNo interventionThe investigating physicians of the participating centers in the control group will be free to provide care as they see fit. However, a reminder of national and European guidelines for PE management will be given to them and they will have the recommendation to apply a validated strategy. To make it easier, the different scores will be included in the clinical help-decision support software called SPEED. Investigators will be asked to enter data about the included patients directly into SPEED, which will act as the study's electronic case report form (eCRF). A paper version of the CRF will also be available.
Intervention group - 4PEPS strategyActive comparatorPhysicians of the participating centers in the intervention group will have the recommendation to apply the 4PEPS strategy. To make it easier to apply, the 4PEPS score will be included in SPEED. Investigators will be asked to enter the information relating to patients included in the study directly into SPEED before performing any testing. Entering these data will enable the 4PEPS score to be calculated automatically and specific recommendations to be provided. A paper version of the CRF will also be available
Receives: Diagnostic Test: 4PEPS strategy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of serious clinical events in the 90 days following inclusion

    The primary safety endpoint will be the rate of serious clinical events in the 90 days following inclusion: • Serious adverse events related to diagnostic testing (leading to hospitalization or prolongation of hospitalization, permanent inability or incapacity, and death). • Symptomatic thromboembolic events in patients not diagnosed with PE in the emergency department or new thromboembolic events in patients diagnosed with PE. • Death related to PE (initial or recurrent PE). • Major bleeding related to an anticoagulant treatment prescribed for pulmonary embolism according to ISTH criteria.

    Measured: 90 days

  2. Rate of diagnostic thoracic imaging

    The primary efficacy endpoint will be the rate of thoracic imaging among all included patients with suspected PE. The following examinations are considered if they are performed at the request of the emergency physician in search of PE: computed tomography pulmonary angiography (CTPA), planar perfusion or perfusion-ventilation scintigraphy, and SPECT scintigraphy.

    Measured: up to 72 hours following inclusion

Secondary outcomes (4)

  1. Rate of thromboembolic events occurring in the 90 days following inclusion in patients for whom PE was ruled out according to the 4PEPS strategy in the intervention group

    The first secondary objective is to demonstrate, in the intervention group, that the risk of false-negative diagnosis with the 4PEPS strategy is very low in accordance with the International Society of Thrombosis and Hemostasis (ISTH) criteria for validation of rule-out PE diagnostic strategies.

    The endpoint will be the false-negative rate defined as the rate of thromboembolic events occurring in the 90 days following inclusion in patients in the intervention group for whom PE was ruled out according to the 4PEPS strategy and who were not treated with anticoagulants.

    Measured: 90 days

  2. Rate of thromboembolic events occurring in the 90 days following inclusion in patients for whom PE was ruled out in both groups

    The second secondary objective is to demonstrate that the 4PEPS strategy (intervention group) is not inferior to current practices (control group) as regards the risk of false-negative diagnosis.

    The false-negative rate will be defined as the rate of thromboembolic events occurring in the 90 days following inclusion in patients for whom PE was ruled out and who were not treated with anticoagulants.

    Measured: 90 days

  3. Rate of D-dimer measurement

    The third secondary objective is to to evaluate and compare to usual practice the impact of the 4PEPS strategy as regards the rate of D-dimer measurement.

    Measured: up to 72 hours following inclusion

  4. Length of stay in ED

    The fourth secondary objective is to evaluate and compare to usual practice the impact of the 4PEPS strategy as regards the length of time spent in the emergency department by patients with suspected PE.

    Measured: Up to Emergency Department discharge (assessed up to 48 hours)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2023
  2. Study start29 Nov 2023
  3. Primary completion15 May 2025
  4. Study completion10 Nov 2025

Resources

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
Randomised
Intervention model
Parallel groups
Model description
Pragmatic cluster-randomized trial
Masking
None (open label)
Enrolment
3,084 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06015529
Sponsor's protocol ID
49RC20_0017
Acronym
SPEED&PEPS
Status last verified
Mar 2026
First submitted
31 Jul 2023
Last updated
17 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data will be shared upon reasonable request. Only de-identified data will be shared. Any data collected during the study may be shared. The protocol will be shared initially. Other documents may be shared at a later date upon request (e.g., the CRF to allow a collaborator to select the data they wish to access). The recipients of the data will be researchers. The data will be available for any purpose deemed relevant by the study investigator, based on a protocol provided by the requester, after verification of the obtaining of regulatory approvals, including the favorable opinion of an ethics committee.

Publications

  • Roy PM, Friou E, Germeau B, Douillet D, Kline JA, Righini M, Le Gal G, Moumneh T, Penaloza A. Derivation and Validation of a 4-Level Clinical Pretest Probability Score for Suspected Pulmonary Embolism to Safely Decrease Imaging Testing. JAMA Cardiol. 2021 Jun 1;6(6):669-677. doi: 10.1001/jamacardio.2021.0064.

    PubMed 33656522

  • Roy PM, Durieux P, Gillaizeau F, Legall C, Armand-Perroux A, Martino L, Hachelaf M, Dubart AE, Schmidt J, Cristiano M, Chretien JM, Perrier A, Meyer G. A computerized handheld decision-support system to improve pulmonary embolism diagnosis: a randomized trial. Ann Intern Med. 2009 Nov 17;151(10):677-86. doi: 10.7326/0003-4819-151-10-200911170-00003.

    PubMed 19920268

  • Roy PM, Moumneh T, Penaloza A, Schmidt J, Charpentier S, Joly LM, Riou J, Douillet D. Diagnostic Strategy for Suspected Pulmonary Embolism in Emergency Departments Based on the 4-Level Pulmonary Embolism Clinical Probability Score: Study Protocol of SPEED&PEPS Trial. Diagnostics (Basel). 2022 Dec 9;12(12):3101. doi: 10.3390/diagnostics12123101.

    PubMed 36553108

Questions about this trial

What is this clinical trial studying?

A study testing 4PEPS strategy in people with Pulmonary Embolism, run by University Hospital, Angers at 23 sites in 2 countries.

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 2 inclusion and 9 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 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in France, Belgium. 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?

Rate of serious clinical events in the 90 days following inclusion (time frame: 90 days). The study lists 2 primary outcomes in all. 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 NCT06015529, which also lists 3 linked publications.

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 17 Jul 2026.

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