Pulmonary EmbolismMODS STRATEGYNCT06190392
Effect of a Global Simplified Strategy on Thromboembolic Events in Emergency Department Patients with Suspected Pulmonary Embolism
A study testing MODS Modified simplified diagnostic strategy in people with Pulmonary Embolism, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Pulmonary embolism (PE) is frequently suspected in emergency departments (ED) patients which often leads to the prescription of DDimer testing and irradiative chest imaging (Computed Tomographic Pulmonary Angiogram CTPA in most cases).[1] Indeed, an increased use of CTPA has been reported without clear benefit in… 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?
- MODS Modified simplified diagnostic strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,223 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jan 2024to 21 Jan 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
- Age ≥ 18 years
- ED adult patients with suspected pulmonary embolism defined as:
- New onset of or worsening shortness of breath
- Or Chest pain
- Or Syncope in the absence of any obvious other cause (such as pneumothorax, asthma attack, ST elevation myocardial infarction, trauma, etc.)
- Patient able to understand and give oral consent
- Informing and obtaining the patient's oral consent
- Social security affiliation (except AME)
Who cannot join
- Patients currently treated with full-dose anticoagulant therapy
- Diagnosed thrombo-embolic event in the past 6 months
- PE ruled out by the PERC rule (low clinical probability and none of the 8 items of the PERC score)
- Acute severe presentation (clinical signs of respiratory distress, hypotension, SpO2 < 90%, shock)
- DDimer level known before ED visit
- Patient living in assisted-living home or nursing home or palliative center. Anticipated life expectancy < 3 months or "do not resuscitate" order
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- Patient under legal protection measure (tutorship or curatorship) and patient deprived of freedom
- Pregnancy and breastfeeding
- Participation in another interventional trial
Trial locations and contacts
1 site in 1 country.
About this study
Pulmonary embolism (PE) is frequently suspected in emergency departments (ED) patients which often leads to the prescription of DDimer testing and irradiative chest imaging (Computed Tomographic Pulmonary Angiogram CTPA in most cases).[1] Indeed, an increased use of CTPA has been reported without clear benefit in terms of prognosis.This increased use is reportedly associated with potential overdiagnosis of PE, increased cost, length of ED stay, and side effects from both chest imaging and undue anticoagulant treatments. The standard diagnostic strategy for PE work up includes three steps with an initial evaluation of clinical probability, followed by D-dimer testing if indicated, followed by chest imaging if necessary - Computed tomographic pulmonary angiogram CTPA being the imaging modality of choice.
A large European prospective study has reported that the use of CTPA has constantly increased without change in the diagnostic yield. In order to reduce the use of CTPA, it has been validated that in patients with a low likelihood of PE, the D-dimer threshold for ordering CTPA can be raised at 1000 ng/ml. It has been validated that a low likelihood of PE can be determined either with the YEARS or the PEGeD clinical decision rules. These latter two include one common item being "Is PE the most likely diagnosis". A retrospective cohort study of 3330 patients reported that using this sole question of "Is PE the most likely diagnosis" can be safely used to raise the D-dimer threshold to 1000 ng/ml, and that this performs as well as YEARS and PEGeD. This simple question is easier to use by emergency physicians compared to complex ones, which are reportedly seldom used by emergency physicians. Therefore, the validation of the "PE unlikely" simple and straightforward decision rule could increase physicians' adherence and therefore limit the use of chest imaging.
Read more
The hypothesis of this prospective study is that the likelihood of PE assessed to elevate the DDimer threshold to 1000 ng/ml can be estimated by the sole question of "is PE the most likely diagnosis", and to validate a global simplified diagnostic strategy for PE in the ED.
The intervention will be the patient's management with a simplified global strategy. Whether PE is the most likely diagnostic will be assessed by the unstructured implicit clinician's estimation.
In patient with a clinical suspicion of pulmonary embolism: DDimer testing will be performed.
If the likelihood of PE is low (PE is not the most likely diagnosis), then threshold for DDimer testing will be 1000 ng/ml. If the likelihood of PE is high (PE is the most likely diagnosis), then the age-adjusted DDimer threshold will be applied.
- Conditions
- Pulmonary Embolism
- Being tested
- MODS Modified simplified diagnostic strategy
- Keywords
- Pulmonary Embolism, Emergency department, PERC Rule
- Medical subject headings
- Pulmonary Embolism, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MODS Modified simplified diagnostic strategyOther
The intervention will be the patient's management with a simplified global strategy. Whether PE is the most likely diagnostic will be assessed by the unstructured implicit clinician's estimation.
In patient with a clinical suspicion of pulmonary embolism: DDimer testing will be performed.
If the likelihood of PE is low (PE is not the most likely diagnosis), then threshold for DDimer testing will be 1000 ng/ml. If the likelihood of PE is high (PE is the most likely diagnosis), then the age-adjusted DDimer threshold will be applied.
| Study group | Role | What they receive |
|---|---|---|
| Modified simplified diagnostic strategy MODS | Experimental | Not described Receives: Other: MODS Modified simplified diagnostic strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The failure proportion of the diagnostic strategy, defined as a diagnosed thrombo-embolic event at 3 months follow-up (either a PE or a deep venous thrombosis), among patients in whom PE was initially ruled out.
Measured: 3 months
Secondary outcomes (8)
Pulmonary embolism
Measured: 3 months
Deep venous thrombosis
Measured: 3 months
CTPA or V/Q scan ordered by ED physicians
Measured: 3 months
Type of PE (lobar, segmental, sub-segmental)
Measured: 3 months
Hospital admission following the ED visit
Measured: 3 months
Anticoagulant therapy administration,
Measured: 3 months
All-cause mortality
Measured: 3 months
All-cause readmissions at 3 months
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start19 Jan 2024
- Primary completion21 Jan 2025
- Study completion21 Jan 2025
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.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- 1,223 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Héloïse BANNELIER, MD, MSc, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06190392
- Sponsor's protocol ID
- APHP230886
- Other IDs
- 2023-A01956-39
- Acronym
- MODS STRATEGY
- Status last verified
- Feb 2025
- First submitted
- 19 Dec 2023
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Roussel M, Bannelier H, Lebal S, Kassasseya C, Bouzid D, Peyrony O, Baud A, Chauvin A, Beauvais A, Javaud N, Gorlicki J, Truchot J, Le Borgne P, Chocron R, Simon T, Freund Y. D-Dimer thresholds for diagnosis of pulmonary embolism based on a single question: is it the most likely diagnosis? A prospective, multicentre, open-label, single-arm interventional study. Lancet Respir Med. 2026 Jan;14(1):29-37. doi: 10.1016/S2213-2600(25)00292-9. Epub 2025 Oct 21.
PubMed 41135553
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Global Simplified Strategy on Thromboembolic Events in Emergency Department Patients with Suspected Pulmonary Embolism
- ClinicalTrials.gov ID
- NCT06190392
- Acronym / sponsor ID
- MODS STRATEGY / APHP230886
- Conditions
- Pulmonary Embolism
- Keywords
- Pulmonary Embolism, Emergency department, PERC Rule
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,223 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 19 Jan 2024 (actual)
- Primary completion
- 21 Jan 2025 (actual)
- Study completion
- 21 Jan 2025 (actual)
- First posted
- 5 Jan 2024 (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.
Pulmonary embolism (PE) is frequently suspected in emergency departments (ED) patients which often leads to the prescription of DDimer testing and irradiative chest imaging (Computed Tomographic Pulmonary Angiogram CTPA in most cases).[1] Indeed, an increased use of CTPA has been reported without clear benefit in terms of prognosis.This increased use is reportedly associated with potential overdiagnosis of PE, increased cost, length of ED stay, and side effects from both chest imaging and undue anticoagulant treatments. The standard diagnostic strategy for PE work up includes three steps with an initial evaluation of clinical probability, followed by D-dimer testing if indicated, followed by chest imaging if necessary - Computed tomographic pulmonary angiogram CTPA being the imaging modality of choice.
A large European prospective study has reported that the use of CTPA has constantly increased without change in the diagnostic yield. In order to reduce the use of CTPA, it has been validated that in patients with a low likelihood of PE, the D-dimer threshold for ordering CTPA can be raised at 1000 ng/ml. It has been validated that a low likelihood of PE can be determined either with the YEARS or the PEGeD clinical decision rules. These latter two include one common item being "Is PE the most likely diagnosis". A retrospective cohort study of 3330 patients reported that using this sole question of "Is PE the most likely diagnosis" can be safely used to raise the D-dimer threshold to 1000 ng/ml, and that this performs as well as YEARS and PEGeD. This simple question is easier to use by emergency physicians compared to complex ones, which are reportedly seldom used by emergency physicians. Therefore, the validation of the "PE unlikely" simple and straightforward decision rule could increase physicians' adherence and therefore limit the use of chest imaging.
The hypothesis of this prospective study is that the likelihood of PE assessed to elevate the DDimer threshold to 1000 ng/ml can be estimated by the sole question of "is PE the most likely diagnosis", and to validate a global simplified diagnostic strategy for PE in the ED.
The intervention will be the patient's management with a simplified global strategy. Whether PE is the most likely diagnostic will be assessed by the unstructured implicit clinician's estimation.
In patient with a clinical suspicion of pulmonary embolism: DDimer testing will be performed.
If the likelihood of PE is low (PE is not the most likely diagnosis), then threshold for DDimer testing will be 1000 ng/ml. If the likelihood of PE is high (PE is the most likely diagnosis), then the age-adjusted DDimer threshold will be applied.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Modified simplified diagnostic strategy MODS | Experimental | Other: MODS Modified simplified diagnostic strategy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years
- ED adult patients with suspected pulmonary embolism defined as:
- Patient able to understand and give oral consent
- Informing and obtaining the patient's oral consent
- Social security affiliation (except AME)
Key exclusion criteria (9 listed)
- Patients currently treated with full-dose anticoagulant therapy
- Diagnosed thrombo-embolic event in the past 6 months
- PE ruled out by the PERC rule (low clinical probability and none of the 8 items of the PERC score)
- Acute severe presentation (clinical signs of respiratory distress, hypotension, SpO2 < 90%, shock)
- DDimer level known before ED visit
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 |
|---|---|---|
| MODS Modified simplified diagnostic strategyThe intervention will be the patient's management with a simplified global strategy. Whether PE is the most likely diagnostic will be assessed by the unstructured implicit clinician's estimation. In patient with a clinical suspicion of pulmonary embolism: DDimer testing will be performed. If the likelihood of PE is low (PE is not the most likely diagnosis), then threshold for DDimer testing will be 1000 ng/ml. If the likelihood of PE is high (PE is the most likely diagnosis), then the age-adjusted DDimer threshold will be applied. | Other | Modified simplified diagnostic strategy MODS |
Primary outcome
The failure proportion of the diagnostic strategy, defined as a diagnosed thrombo-embolic event at 3 months follow-up (either a PE or a deep venous thrombosis), among patients in whom PE was initially ruled out.
Time frame: 3 months
8 secondary outcomes
Pulmonary embolism
Time frame: 3 months
Deep venous thrombosis
Time frame: 3 months
CTPA or V/Q scan ordered by ED physicians
Time frame: 3 months
Type of PE (lobar, segmental, sub-segmental)
Time frame: 3 months
Hospital admission following the ED visit
Time frame: 3 months
Anticoagulant therapy administration,
Time frame: 3 months
All-cause mortality
Time frame: 3 months
All-cause readmissions at 3 months
Time frame: 3 months
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 7 Feb 2025.
- Derived from this study: PubMed 41135553Roussel M, Bannelier H, Lebal S, Kassasseya C, Bouzid D, Peyrony O, Baud A, Chauvin A, Beauvais A, Javaud N, Gorlicki J, Truchot J, Le Borgne P, Chocron R, Simon T, Freund Y. D-Dimer thresholds for diagnosis of pulmonary embolism based on a single question: is it the most likely diagnosis? A prospective, multicentre, open-label, single-arm interventional study. Lancet Respir Med. 2026 Jan;14(1):29-37. doi: 10.1016/S2213-2600(25)00292-9. Epub 2025 Oct 21.
- Individual participant dataSharing planned: Undecided
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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.
Héloïse BANNELIER, MD, MSc principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MODS Modified simplified diagnostic strategy in people with Pulmonary Embolism, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 8 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 7 Feb 2025. 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 France. 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?
The failure proportion of the diagnostic strategy, defined as a diagnosed thrombo-embolic event at 3 months follow-up (either a PE or a deep venous thrombosis), among patients in whom PE was initially ruled out. (time frame: 3 months). 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 NCT06190392, 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 7 Feb 2025; AzTrials last refreshed its copy on 7 Nov 2026.