Pulmonary EmbolismMODIGLIA-NINCT04032769
Modified Strategy to Safely Rule Out Pulmonary Embolism in the Emergency Department
A study testing MODS (MOdified Diagnostic Strategy) in people with Pulmonary Embolism, run by Assistance Publique - Hôpitaux de Paris at 2 sites in 2 countries.
Trial summary
Because a missed PE could be potentially lethal, several researches reported that PE is both overinvestigated and overdiagnosed. The diagnostic gold standard for PE is the computed tomographic pulmonary angiogram (CTPA) and has been shown to have clear risks and other downsides. 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 Diagnostic Strategy)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,414 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Oct 2019to 20 Nov 2020
- 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
- Patient aged ≥ 18 years that presents to an ED
- With new onset of or worsening of shortness of breath or chest pain or syncope
Who cannot join
- Opposition to the participation to the study
- Anticipated inability to follow up at 3 month
- Other obvious cause than PE for chest pain, syncope or dyspnea
- High clinical probability of PE (estimated by the physician gestalt as > 50%) or low clinical probability and PERC negative patients
- Low clinical probability (estimated by the physician gestalt as < 15%) and no item of the PERC score (heart rate > 100, Sa02 < 95, unilateral leg swelling, hemoptysis, past history of thrombo-embolism, exogen estrogen intake, recent trauma or surgery, age ≥ 50)
- Acute severe presentation (clinical signs of respiratory distress, hypotension, SpO2<90%, shock)
Show all 12Show fewer
- Concurrent anticoagulation treatment
- Current diagnosed thrombo-embolic event (in the past 6 months)
- Prisoners
- Pregnancy
- No social security
- Participation in another intervention trial
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: MOdified DIagnostic strateGy to Safely ruLe-out Pulmonary Embolism In the Emergency depArtment: A Non-Inferiority Cluster Cross-over Randomized Trial
Because a missed PE could be potentially lethal, several researches reported that PE is both overinvestigated and overdiagnosed. The diagnostic gold standard for PE is the computed tomographic pulmonary angiogram (CTPA) and has been shown to have clear risks and other downsides. To limit the use of CTPA, two rules were recently reported to be safe to exclude PE: the PERC rule and the YEARS rule. PERC is an 8 item block of clinical criteria that has recently been validated to safely exclude PE in low risk patients. YEARS is a clinical rule that allow to raise the threshold of D-dimer for the order of CTPA. However, whether a modified diagnostic algorithm that includes these two rules combined could safely reduce imaging study use in the ED is unknown.
This is a non-inferiority, cluster cross-over randomized, international trial.
Read more
Each center will be randomized on the sequence of period intervention: 4 months intervention (MOdified Diagnostic Strategy: MODS) followed by 4 months control (usual care), or 4 months control followed by 4 months intervention with 1 month of "wash-out" between the two periods.
All centers will recruit adult emergency patients with a suspicion of PE.
In the control group (usual strategy), patients will be tested for D-dimer, followed if positive by a CTPA.
In the intervention group (MODS) :
All included patients will be tested with quantitative D-dimer. The MODS work-up will be based on YEARS rule :
- If all YEARS criteria are absent, the threshold of D-Dimer for ordering a CTPA will be raised.
If at least one criterion of YEARS is present, then the D-dimer threshold for ordering a CTPA will be as usual.
Read the detailed description
The diagnosis of Pulmonary Embolism (PE) is a crucial matter in the Emergency Department (ED). Because a missed PE could be potentially lethal, several researches reported that PE is both overinvestigated and overdiagnosed. The diagnostic gold standard for PE is the computed tomographic pulmonary angiogram (CTPA) and has been shown to have clear risks (allergic reaction, acute renal failure, delayed solid tumor) and other downsides such as prolonged ED stay and increased cost. To limit the use of CTPA, two rules were recently reported to be safe to exclude PE: the PERC rule and the YEARS rule.
PERC is an 8 item block of clinical criteria that has recently been validated to safely exclude PE in low risk patients.
YEARS is a clinical rule that allow to raise the threshold of D-dimer for the order of CTPA. However, whether a modified diagnostic algorithm that includes these two rules combined could safely reduce imaging study use in the ED is unknown.
The primary objective of this trial is to assess the safety of a modified diagnostic strategy (MODS) with the YEARS for patients in whom PE was not excluded by PERC score in the ED.
The primary endpoint is the failure percentage of the diagnostic strategy, defined as a diagnosed thrombo-embolic event at 3 month follow-up (either a PE or a deep venous thrombosis), among patients in whom PE has been initially ruled out.
The secondary outcomes try to assess the efficacy of the modified diagnostic strategy (MODS) in reducing order of irradiative imaging studies, ED length of stay, undue onset of anticoagulation regimen, hospital admission, hospital readmission, and mortality at 3 months.
To evaluate the efficacy of the modified diagnostic strategy to reduce overall 3-months total cost.
Secondary endpoints include:
- CTPA or V/Q scan
- Anticoagulant therapy administration
- Length of stay in the ED (hours)
- Admission to the hospital following ED visit.
- All causes re hospitalization at 3 months,
- Death from all causes at 3 months
- Diagnosed pulmonary embolism at 3 month follow-up excluding the isolated sub-segmental pulmonary embolism, among patients in whom PE has been initially ruled out
- PEPS score
- 3 months total cost and cost effectiveness
In the Modified diagnostic strategy (MODS), All included patients will be tested with quantitative D-dimer. The MODS work-up strategy will be based on YEARS rule, that included three criteria (hemoptysis, signs of DVT, PE is the most likely diagnosis)
- If all YEARS criteria are absent, the threshold of D-Dimer for ordering a CTPA will be raised at 1000 ng/ml.
If at least one criterion of YEARS is present, then the D-dimer threshold for ordering a CTPA will be as usual (500 ng/ml, or agex10 for patients aged 50 and over)
Group control :
All included patients will be tested with D-Dimer, the threshold for ordering a CTPA will be as usual (conventional age-adjusted threshold at 500 ng/ml, or agex10 for patients aged 50 and over).
Safely reducing the use of CTPA would be beneficial for the patients, by limiting their risk of associated adverse events and overdiagnosis of PE, and will also reduce their length of stay in the ED, which is associated with better outcomes. Furthermore, reducing supplemental investigations for patients with suspicion of PE may also reduce the cost of ED visits, which would be of great benefit in the context of increasingly resource stretched healthcare services.
- Conditions
- Pulmonary Embolism
- Being tested
- MODS (MOdified Diagnostic Strategy)
- Keywords
- Pulmonary embolism, PERC Rule, Years Rule, Peps Rule, Emergency department
- 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 Diagnostic Strategy)Other
Modified diagnostic strategy (MODS):
All included patients will be tested with quantitative D-dimer. The MODS work-up strategy will be based on YEARS rule, that included three criteria (hemoptysis, signs of DVT, PE is the most likely diagnosis)
- If all YEARS criteria are absent, the threshold of D-Dimer for ordering a CTPA will be raised at 1000 ng/ml.
If at least one criterion of YEARS is present, then the D-dimer threshold for ordering a CTPA will be as usual (500 ng/ml, or agex10 for patients aged 50 and over)
| Study group | Role | What they receive |
|---|---|---|
| Modified strategy MODS | Experimental | the threshold of D-dimer will depend on the YEARS rule (MODS strategy):
1. If all the three items of YEARS are negative (i.e. No hemoptysis, No clinical sign of deep venous thrombosis and PE is not the most likely diagnosis), then the threshold of D-dimer will be raised at 1000 ng/ml.
2. If at least one item of YEARS is positive, then the threshold will remain unchanged (">500 ng/ml" for patients aged < 50 and "> agex10" for patients aged 50 and over).
* A positive result of D-dimer and the absence of other obvious cause for PE will mandate a CTPA, or V/Q scan if CTPA is contra-indicated.
* A negative result of D-dimer will rule out PE. Receives: Other: MODS (MOdified Diagnostic Strategy) |
| Control group | No intervention | All included patients will be tested with D-Dimer, threshold for ordering a CTPA as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
the failure percentage of the diagnostic strategy, defined as a diagnosed thrombo-embolic event at 3 month follow-up
existence of a diagnosed thrombo embolic event (PE or DVT) among patients in whom PE has been initially ruled out.
Measured: 3 months follow up
Secondary outcomes (8)
reduced irradiative imaging studies
CTPA or V/Q scan
Measured: 3 months follow up
ED length of stay
length of stay in the ED (hours)
Measured: Through ED Discharge within 24 hours
anticoagulant therapy administration
onset of anticoagulant regimen
Measured: 3 months follow up
hospital admission
admission to the hospital following ED visit
Measured: 3 months follow up
hospital re admission
all causes re hospitalization at 3 months
Measured: 3 months
mortality
Death from all causes at 3 months
Measured: 3 months
Safety of the PEPS score
performance characteristic of the PEPS score for the diagnosis of PE both in the ED and at 3 Months. The false negative rate of PEPS score will be tested, as the theoretical percentage of indicated CTPA according to its value.
Measured: 3 months
total cost and cost effectiveness
total cost and cost effectiveness (cost per major adverse event averted, namely hospitalisation, rehospitalisation, imaging study, death).
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 posted25 Jul 2019
- Study start1 Oct 2019
- Primary completion20 Nov 2020
- Study completion20 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 1,414 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yonathan Freund, professor, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04032769
- Sponsor's protocol ID
- APHP180595
- Acronym
- MODIGLIA-NI
- Status last verified
- Apr 2021
- First submitted
- 18 Jul 2019
- Last updated
- 3 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Yes, upon request, after approval by the primary investigator and clinical research platform of East Paris. For the purpose of IPD meta-analysis, or secondary analysis. Unidentifying data will be shared.
Publications
Nze Ossima A, Ngaleu Siaha BF, Mimouni M, Mezaour N, Darlington M, Berard L, Cachanado M, Simon T, Freund Y, Durand-Zaleski I. Cost-effectiveness of modified diagnostic strategy to safely rule-out pulmonary embolism in the emergency department: a non-inferiority cluster crossover randomized trial (MODIGLIA-NI). BMC Emerg Med. 2023 Nov 29;23(1):140. doi: 10.1186/s12873-023-00910-x.
PubMed 38030975Freund Y, Chauvin A, Jimenez S, Philippon AL, Curac S, Femy F, Gorlicki J, Chouihed T, Goulet H, Montassier E, Dumont M, Lozano Polo L, Le Borgne P, Khellaf M, Bouzid D, Raynal PA, Abdessaied N, Laribi S, Guenezan J, Ganansia O, Bloom B, Miro O, Cachanado M, Simon T. Effect of a Diagnostic Strategy Using an Elevated and Age-Adjusted D-Dimer Threshold on Thromboembolic Events in Emergency Department Patients With Suspected Pulmonary Embolism: A Randomized Clinical Trial. JAMA. 2021 Dec 7;326(21):2141-2149. doi: 10.1001/jama.2021.20750.
PubMed 34874418Philippon AL, Dumont M, Jimenez S, Salhi S, Cachanado M, Durand-Zaleski I, Simon T, Freund Y. MOdified DIagnostic strateGy to safely ruLe-out pulmonary embolism In the emergency depArtment: study protocol for the Non-Inferiority MODIGLIANI cluster cross-over randomized trial. Trials. 2020 Jun 3;21(1):458. doi: 10.1186/s13063-020-04379-y.
PubMed 32493383
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MOdified DIagnostic strateGy to Safely ruLe-out Pulmonary Embolism In the Emergency depArtment: A Non-Inferiority Cluster Cross-over Randomized Trial
- ClinicalTrials.gov ID
- NCT04032769
- Acronym / sponsor ID
- MODIGLIA-NI / APHP180595
- Conditions
- Pulmonary Embolism
- Keywords
- Pulmonary embolism, PERC Rule, Years Rule, Peps Rule, Emergency department
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,414 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 20 Nov 2020 (actual)
- Study completion
- 20 Nov 2020 (actual)
- First posted
- 25 Jul 2019 (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.
Because a missed PE could be potentially lethal, several researches reported that PE is both overinvestigated and overdiagnosed. The diagnostic gold standard for PE is the computed tomographic pulmonary angiogram (CTPA) and has been shown to have clear risks and other downsides. To limit the use of CTPA, two rules were recently reported to be safe to exclude PE: the PERC rule and the YEARS rule. PERC is an 8 item block of clinical criteria that has recently been validated to safely exclude PE in low risk patients. YEARS is a clinical rule that allow to raise the threshold of D-dimer for the order of CTPA. However, whether a modified diagnostic algorithm that includes these two rules combined could safely reduce imaging study use in the ED is unknown.
This is a non-inferiority, cluster cross-over randomized, international trial.
Each center will be randomized on the sequence of period intervention: 4 months intervention (MOdified Diagnostic Strategy: MODS) followed by 4 months control (usual care), or 4 months control followed by 4 months intervention with 1 month of "wash-out" between the two periods.
All centers will recruit adult emergency patients with a suspicion of PE.
In the control group (usual strategy), patients will be tested for D-dimer, followed if positive by a CTPA.
In the intervention group (MODS) :
All included patients will be tested with quantitative D-dimer. The MODS work-up will be based on YEARS rule :
- If all YEARS criteria are absent, the threshold of D-Dimer for ordering a CTPA will be raised.
If at least one criterion of YEARS is present, then the D-dimer threshold for ordering a CTPA will be as usual.
Detailed description
The diagnosis of Pulmonary Embolism (PE) is a crucial matter in the Emergency Department (ED). Because a missed PE could be potentially lethal, several researches reported that PE is both overinvestigated and overdiagnosed. The diagnostic gold standard for PE is the computed tomographic pulmonary angiogram (CTPA) and has been shown to have clear risks (allergic reaction, acute renal failure, delayed solid tumor) and other downsides such as prolonged ED stay and increased cost. To limit the use of CTPA, two rules were recently reported to be safe to exclude PE: the PERC rule and the YEARS rule.
PERC is an 8 item block of clinical criteria that has recently been validated to safely exclude PE in low risk patients.
YEARS is a clinical rule that allow to raise the threshold of D-dimer for the order of CTPA. However, whether a modified diagnostic algorithm that includes these two rules combined could safely reduce imaging study use in the ED is unknown.
The primary objective of this trial is to assess the safety of a modified diagnostic strategy (MODS) with the YEARS for patients in whom PE was not excluded by PERC score in the ED.
The primary endpoint is the failure percentage of the diagnostic strategy, defined as a diagnosed thrombo-embolic event at 3 month follow-up (either a PE or a deep venous thrombosis), among patients in whom PE has been initially ruled out.
The secondary outcomes try to assess the efficacy of the modified diagnostic strategy (MODS) in reducing order of irradiative imaging studies, ED length of stay, undue onset of anticoagulation regimen, hospital admission, hospital readmission, and mortality at 3 months.
To evaluate the efficacy of the modified diagnostic strategy to reduce overall 3-months total cost.
Secondary endpoints include:
- CTPA or V/Q scan
- Anticoagulant therapy administration
- Length of stay in the ED (hours)
- Admission to the hospital following ED visit.
- All causes re hospitalization at 3 months,
- Death from all causes at 3 months
- Diagnosed pulmonary embolism at 3 month follow-up excluding the isolated sub-segmental pulmonary embolism, among patients in whom PE has been initially ruled out
- PEPS score
- 3 months total cost and cost effectiveness
In the Modified diagnostic strategy (MODS), All included patients will be tested with quantitative D-dimer. The MODS work-up strategy will be based on YEARS rule, that included three criteria (hemoptysis, signs of DVT, PE is the most likely diagnosis)
- If all YEARS criteria are absent, the threshold of D-Dimer for ordering a CTPA will be raised at 1000 ng/ml.
If at least one criterion of YEARS is present, then the D-dimer threshold for ordering a CTPA will be as usual (500 ng/ml, or agex10 for patients aged 50 and over)
Group control :
All included patients will be tested with D-Dimer, the threshold for ordering a CTPA will be as usual (conventional age-adjusted threshold at 500 ng/ml, or agex10 for patients aged 50 and over).
Safely reducing the use of CTPA would be beneficial for the patients, by limiting their risk of associated adverse events and overdiagnosis of PE, and will also reduce their length of stay in the ED, which is associated with better outcomes. Furthermore, reducing supplemental investigations for patients with suspicion of PE may also reduce the cost of ED visits, which would be of great benefit in the context of increasingly resource stretched healthcare services.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified strategy MODS | Experimental | Other: MODS (MOdified Diagnostic Strategy)the threshold of D-dimer will depend on the YEARS rule (MODS strategy): 1. If all the three items of YEARS are negative (i.e. No hemoptysis, No clinical sign of deep venous thrombosis and PE is not the most likely diagnosis), then the threshold of D-dimer will be raised at 1000 ng/ml. 2. If at least one item of YEARS is positive, then the threshold will remain unchanged (">500 ng/ml" for patients aged < 50 and "> agex10" for patients aged 50 and over). * A positive result of D-dimer and the absence of other obvious cause for PE will mandate a CTPA, or V/Q scan if CTPA is contra-indicated. * A negative result of D-dimer will rule out PE. |
| Control group | No intervention | –All included patients will be tested with D-Dimer, threshold for ordering a CTPA as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient aged ≥ 18 years that presents to an ED
- With new onset of or worsening of shortness of breath or chest pain or syncope
Key exclusion criteria (12 listed)
- Opposition to the participation to the study
- Anticipated inability to follow up at 3 month
- Other obvious cause than PE for chest pain, syncope or dyspnea
- High clinical probability of PE (estimated by the physician gestalt as > 50%) or low clinical probability and PERC negative patients
- Low clinical probability (estimated by the physician gestalt as < 15%) and no item of the PERC score (heart rate > 100, Sa02 < 95, unilateral leg swelling, hemoptysis, past history of thrombo-embolism, exogen estrogen intake, recent trauma or surgery, age ≥ 50)
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 Diagnostic Strategy)Modified diagnostic strategy (MODS): All included patients will be tested with quantitative D-dimer. The MODS work-up strategy will be based on YEARS rule, that included three criteria (hemoptysis, signs of DVT, PE is the most likely diagnosis) - If all YEARS criteria are absent, the threshold of D-Dimer for ordering a CTPA will be raised at 1000 ng/ml. If at least one criterion of YEARS is present, then the D-dimer threshold for ordering a CTPA will be as usual (500 ng/ml, or agex10 for patients aged 50 and over) | Other | Modified strategy MODS |
Primary outcome
the failure percentage of the diagnostic strategy, defined as a diagnosed thrombo-embolic event at 3 month follow-up
Time frame: 3 months follow up
existence of a diagnosed thrombo embolic event (PE or DVT) among patients in whom PE has been initially ruled out.
8 secondary outcomes
reduced irradiative imaging studies
Time frame: 3 months follow up
ED length of stay
Time frame: Through ED Discharge within 24 hours
anticoagulant therapy administration
Time frame: 3 months follow up
hospital admission
Time frame: 3 months follow up
hospital re admission
Time frame: 3 months
mortality
Time frame: 3 months
Safety of the PEPS score
Time frame: 3 months
total cost and cost effectiveness
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 3 May 2021.
- Derived from this study: PubMed 38030975Nze Ossima A, Ngaleu Siaha BF, Mimouni M, Mezaour N, Darlington M, Berard L, Cachanado M, Simon T, Freund Y, Durand-Zaleski I. Cost-effectiveness of modified diagnostic strategy to safely rule-out pulmonary embolism in the emergency department: a non-inferiority cluster crossover randomized trial (MODIGLIA-NI). BMC Emerg Med. 2023 Nov 29;23(1):140. doi: 10.1186/s12873-023-00910-x.
- Derived from this study: PubMed 34874418Freund Y, Chauvin A, Jimenez S, Philippon AL, Curac S, Femy F, Gorlicki J, Chouihed T, Goulet H, Montassier E, Dumont M, Lozano Polo L, Le Borgne P, Khellaf M, Bouzid D, Raynal PA, Abdessaied N, Laribi S, Guenezan J, Ganansia O, Bloom B, Miro O, Cachanado M, Simon T. Effect of a Diagnostic Strategy Using an Elevated and Age-Adjusted D-Dimer Threshold on Thromboembolic Events in Emergency Department Patients With Suspected Pulmonary Embolism: A Randomized Clinical Trial. JAMA. 2021 Dec 7;326(21):2141-2149. doi: 10.1001/jama.2021.20750.
- Derived from this study: PubMed 32493383Philippon AL, Dumont M, Jimenez S, Salhi S, Cachanado M, Durand-Zaleski I, Simon T, Freund Y. MOdified DIagnostic strateGy to safely ruLe-out pulmonary embolism In the emergency depArtment: study protocol for the Non-Inferiority MODIGLIANI cluster cross-over randomized trial. Trials. 2020 Jun 3;21(1):458. doi: 10.1186/s13063-020-04379-y.
- Individual participant dataSharing planned: Yes. Yes, upon request, after approval by the primary investigator and clinical research platform of East Paris. For the purpose of IPD meta-analysis, or secondary analysis. Unidentifying data will be shared.
Related trials for Pulmonary Embolism
RecruitingObservational study
Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System
Pulmonary Embolism
Not yet recruiting
Pilot Study Evaluating Catheter Directed Thrombolysis Device in Acute Intermediate Risk Pulmonary Embolism
Pulmonary Embolism (PE), Pulmonary Embolism With Right Ventricle Enlargement
RecruitingObservational study
Inari VISION Registry
Pulmonary Embolism
RecruitingPhase 3
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
Venous Thromboembolism (VTE)
RecruitingPhase 3
REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
Cancer-Associated Thrombosis (CAT)
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.
Yonathan Freund, professor principal investigator
Assistance Publique - Hôpitaux de Paris
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MODS (MOdified Diagnostic Strategy) in people with Pulmonary Embolism, run by Assistance Publique - Hôpitaux de Paris at 2 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 12 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 3 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France, Spain. 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 percentage of the diagnostic strategy, defined as a diagnosed thrombo-embolic event at 3 month follow-up (time frame: 3 months follow up). 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 NCT04032769, 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 3 May 2021.