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New diagnostic approach for suspected pulmonary embolism

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

Not applicable Interventional University Hospital, Angers · NCT06015529

This study is testing a new way to diagnose pulmonary embolism in emergency rooms to see if it can reduce unnecessary scans while keeping patients safe.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment2560 (estimated)
Ages18 Years and up
SexAll
SponsorUniversity Hospital, Angers Government
Locations23 sites (Bruxelles and 22 other locations)
Trial IDNCT06015529 on ClinicalTrials.gov

What this trial studies

This pragmatic cluster-randomized trial aims to evaluate a diagnostic strategy based on the four-level pulmonary embolism probability score (4PEPS) compared to current practices in emergency departments. The study will include patients suspected of having pulmonary embolism (PE) and will follow them for 90 days to assess the impact of the 4PEPS strategy on the use of thoracic imaging and the risk of serious adverse events. A total of 20 emergency departments will participate, with half applying the 4PEPS strategy and the other half following standard practices. The primary goal is to determine if the 4PEPS strategy can reduce unnecessary imaging without compromising patient safety.

Who should consider this trial

Good fit: Ideal candidates are adults admitted to emergency departments with suspected pulmonary embolism due to thoracic symptoms.

Not a fit: Patients under 18 years old, those with known PE diagnoses, or those with hemodynamic instability will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more efficient and safer diagnostic practices for patients suspected of having pulmonary embolism.

How similar studies have performed: Other studies have explored similar diagnostic strategies, but the 4PEPS approach is relatively novel in this context.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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 not including D-dimer test).
* Free, prior, and informed consent to participate in the study.

Exclusion Criteria:

* Age \< 18 years.
* Known result of a specific diagnostic examination for PE (D-dimer test, 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.
* Patient undergoing compulsory psychiatric treatment.
* Patient placed under a legal protection measure.
* Patient incapable of giving free and informed consent.

Where this trial is running

Bruxelles and 22 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Pulmonary Embolismsuspected PEdiagnostic strategyclinical probabilitycluster-randomized trial
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.