Pulmonary EmbolismPRONOSPECTNCT06372730
Residual Pulmonary Vascular Obstruction Index Computed With Ventilation/Perfusion SPECT/CT Imaging to Predict the Risk of Venous Thromboembolism Recurrence in Patients With Pulmonary Embolism (PRONOSPECT)
A study testing Ventilation/Perfusion Single Photon Emission Computed Tomography (V/Q SPECT/CT) in people with Pulmonary Embolism and Venous Thromboembolism, run by University Hospital, Brest at 13 sites in France.
Trial summary
Major risk after pulmonary embolism (PE) is recurrence, fatal in 10% of patients. Patients with PE can be stratified in 3 groups according to the risk of recurrence : very low risk, high risk or Intermediate risk. Little is known about this last group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism, Venous Thromboembolism
- What is being tested?
- Ventilation/Perfusion Single Photon Emission Computed Tomography (V/Q SPECT/CT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 665 participants
- Where
- 13 sitesFrance
- Study dates
- 11 Jun 2024to Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients ≥ 18 years,
- who experienced an objectively proven PE,
- who have been treated initially with anticoagulant therapy for 3 to 6 uninterrupted months (180 - 210 days) and for whom anticoagulation will not be prolonged.
Who cannot join
- Unwilling or unable to give written informed consent (protected adults, under tutorship or curatorship)
- Patients deprived of their liberty by a judicial or administrative decision, patients undergoing psychiatric care by virtue of Articles L. 3212-1 and L. 3213-1 who are not covered by the provisions of Article L. 1121-8 and patients admitted to a health or social establishment for purposes other than research
- No Social security affiliation
- Isolated DVT
- Pregnant women and parturients
- Other indication for anticoagulant therapy (e.g. atrial fibrillation, mechanic valve)
Show all 18Show fewer
- Life expectancy < 6 months
- Any patients for whom there is a strong indication to treat longer than 6 months:
- PE provoked by a major persistent factor (e.g. cancer)
- Recurrent unprovoked PE
- PE provoked by a major transient risk factor (e.g. surgery with general anesthesia for greater than 30 min, confined to bed in hospital for at least 3 days with an acute illness, cesarean section)
- AND none of the following persistent factors :
- BMI ≥ 30
- Chronic respiratory disease
- Chronic inflammatory disease (e.g., ulcerative colitis, rheumatoid arthritis, etc.)
- Hepatocellular insufficiency
- Renal insufficiency with creatinine clearance < 60 mL/min
- Chronic or persistent immobilization
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
France13 sites, 11 recruiting
- Recruiting
CHU Amiens
Amiens, France, 80054
Marie-Antoinette SEVESTRE, Pr, +33322087306, sevestre.marie-antoinette@chu-amiens.fr
- Active, not recruiting
CHU Angers
Angers, France, 49933
- Recruiting
CHU Brest
Brest, France, 29609
Pierre-Yves LE ROUX, Pr, +33298223327, pierre-yves.leroux@chu-brest.fr
Francis COUTURAUD, Pr
- Recruiting
Hôpital Louis MourierAP-HP
Colombes, France, 92700
Isabelle MAHE, Pr, +33147606490, isabelle.mahe@lmr.aphp.fr
- Recruiting
CHD Vendée - La Roche sur Yon
La Roche-sur-Yon, France, 85925
Jean-Manuel KUBINA, Dr, +33251446301, jean-manuel.kubina@ght85.fr
- Active, not recruiting
Kremlin-Bicêtre AP-HP
Le Kremlin-Bicêtre, France, 94270
- Recruiting
CH Les Sables d'Olonne
Les Sables-d'Olonne, France, 85340
Nicolas BREBION, +33251218824, nicolas.brebion@ght85.fr
- Recruiting
Hegp Ap-Hp
Paris, France, 75015
Olivier Sanchez, Pr, +33165093487, olivier.sanchez@aphp.fr
- Recruiting
CH Quimper
Quimper, France, 29000
Charles ORIONE, Dr, +33298526096, charles.orione@ch-cornouaille.fr
- Recruiting
CHU St-Etienne
Saint-Etienne, France, 42055
Laurent BERTOLETTI, Pr, +33477127770, laurent.bertoletti@chu-st-etienne.fr
- Recruiting
CHIC Toulon
Toulon, France, 83056
Jean-Noël POGGI, Dr, +33494145787, jean-noel.poggi@ch-toulon.fr
- Recruiting
HIA Toulon
Toulon, France, 83800
Antoine-Raphaël BRONSTEIN, Dr, +33483162553, antoine-raphael.bronstein@intradef.gouv.fr
- Recruiting
CHU Toulouse
Toulouse, France, 31059
Alessandra BURA-RIVIERE, Pr, +33561322438, bura-riviere.a@chu-toulouse.fr
About this study
Official title: Residual Pulmonary Vascular Obstruction (RPVO) Index Computed With Ventilation/Perfusion SPECT/CT Imaging to Predict the Risk of Venous Thromboembolism (VTE) Recurrence in Patients With Pulmonary Embolism (PE)
Major risk after pulmonary embolism (PE) is recurrence, fatal in 10% of patients. Patients with PE can be stratified in 3 groups according to the risk of recurrence : very low risk, high risk or Intermediate risk. Little is known about this last group.
Anticoagulation is efficient to prevent recurrence but is currently not recommended for patient with an intermediate risk of recurrence.
Read more
Identifying risk factors of recurrent PE remains a major issue to identify sub-groups of patients who would require lifelong anticoagulation.
In 30-40% of cases, PE patients develop residual pulmonary vascular obstruction (RPVO), which has been found to be associated with an increased recurrence risk. This last observation was mostly reported in patients with unprovoked PE (patients with high risk of recurrence) and RPVO was measured using conventional planar lung scan.
In patients with an intermediate risk of recurrence, the impact of RPVO has been much less studied. In addition, the definition of RPVO was variable according to studies and correlation between RPVO burden and recurrence risk has not been clearly demonstrated. This might be explained by the inherent limitation of RPVO quantification using conventional planar imaging, which is only based on a visual estimation on 2-dimensional images.
Ventilation/Perfusion Single Photon Emission Computed Tomography (V/Q SPECT/CT) is a new method of scintigraphic image acquisition that offers the advantage of 3-dimensional imaging, enabling more accurate and reproducible quantification of RPVO.
The main hypothesis of this study is that in patients with PE at intermediate risk of recurrence, RPVO computed with V/Q SPECT/CT imaging may be an important predictor of recurrence.
- Conditions
- Pulmonary Embolism, Venous Thromboembolism
- Being tested
- Ventilation/Perfusion Single Photon Emission Computed Tomography (V/Q SPECT/CT)
- Keywords
- venous thromboembolism recurrence
- Medical subject headings
- Pulmonary Embolism, Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventilation/Perfusion Single Photon Emission Computed Tomography (V/Q SPECT/CT)Other
All patients will undergo a V/Q SPECT/CT scan at inclusion.
| Study group | Role | What they receive |
|---|---|---|
| Patients with PE who have been treated with anticoagulant therapy for 3 to 6 uninterrupted months | Experimental | Patients who experienced an objectively proven PE who have been treated initially with anticoagulant therapy for 3 to 6 uninterrupted months (180 - 210 days) and for whom anticoagulation will not be prolonged. Receives: Other: Ventilation/Perfusion Single Photon Emission Computed Tomography (V/Q SPECT/CT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptomatic recurrent venous thromboembolism (VTE), including objectively confirmed nonfatal symptomatic PE or proximal deep vein thrombosis or fatal PE during a 24-month follow-up after inclusion in the study
In case of a suspected VTE or death during follow-up, the study personnel will collect related clinical data on the electronic case report form, and prepare an adjudication file, including symptoms, clinical notes, hospital discharge summary, and results of all diagnostic tests. All suspicion of VTE recurrence will be adjudicated blindly by an independent central Clinical Events Committee.
To assess the primary objective, RPVO will be defined by a perfusion mismatched defect of at least 5% of the whole lung, corresponding to a segmental defect. SPECT imaging should not be used at inclusion and should not result in proposing prolonged anticoagulation. SPECT images will be numerically stored and interpretation will be later performed independently by two nuclear medicine physicians who will be blinded to clinical history and the patient's outcome. Any difference in interpretation will be resolved by consensus.
Measured: From baseline to Month 24
Secondary outcomes (18)
Adjudicated symptomatic objectively confirmed recurrent VTE during the follow-up period.
Measured: From baseline to Month 24
Percentage of patients with RPVO (as defined by a perfusion defect > 5%) on V/Q SPECT/CT imaging at inclusion in the study.
Measured: Inclusion
Different cut-offs of pulmonary vascular obstruction index will be evaluated to predict the risk of VTE recurrence at 2 years, by generating ROC curves
Measured: Inclusion
Other predictors of adjudicated symptomatic objectively confirmed recurrent VTE at 2 years including: age
Measured: Inclusion
The following score will be computed : HERDOO2 (Hyperpigmentation, Edema, Redness, D-Dimer, Obesity, Old)
Prediction score of recurrence in patients with unprovoked deep vein thrombosis or pulmonary embolism recurrence in patients with unprovoked PE, (test in patients at intermediate risk of recurrence in this trial). Patient with score of 0 to 1 have a low risk of recurrent VTE, whereas patient with a score of at least 2, have a high risk of recurrence
Measured: Inclusion
Potential predictors of RPVO including : demographics
Measured: Inclusion
Symptomatic recurrent VTE during a 3 Months follow-up period in patients with suspicion of PE recurrence who has been left untreated based on a negative V/Q SPECT/CT scan
Symptomatic recurrent VTE including objectively confirmed nonfatal symptomatic PE or proximal DVT or fatal VTE
Measured: 3 Months follow-up period after the suspicion of PE recurrence
Dyspnea index will be assessed using mMRC scale (Modified Medical Research Council)
The mMRC scale is a self-assessment tool used to measure the level of impairment caused by breathlessness during daily activities, rated on a scale from 0 to 4.[2] 0, no breathlessness except on strenuous exercise and 4, too breathless to leave the house, or breathless when dressing or undressing.
Measured: Inclusion and Month 6
Quality of life (QoL) will be assessed using PEmb-Qol (Pulmonary Embolism Quality of Life)
The PEmb-QoL is a validated 40-item questionnaire to quantify health-related quality of life in patients having experienced pulmonary embolism (PE). It covers six health dimensions: frequency of complaints, activities of daily living limitations, work-related problems, social limitations, intensity of complaints, and emotional complaints.The PEmb-QoL dimension scores are calculated by taking the mean of the constituting items. Dimension scores are then transformed to a scale from 0-100 to make them comparable across dimensions, with higher scores indicating worse outcome.
Measured: Inclusion and Month 6
Number of Participants with chronic thromboembolic pulmonary hypertension (CTEPH).
CTEPH will be defined by a mean pulmonary artery pressure >20 mmHg.
Measured: From baseline to Month 24
Mortality of all causes.
Measured: From baseline to Month 24
Percentage of patients with RPVO (> 5%) on V/Q SPECT/CT imaging using Technegas and Krypton.
Measured: Inclusion
The following score will be computed : PADIS-PE score.
PADIS-PE (score derived from the PADIS study : Prolonged Anticoagulation During eighteen months versus placebo after Initial Six-month treatment for a first episode of idiopathic Pulmonary Embolism randomized trial).
A higher score indicates a higher risk of recidive.
Measured: Inclusion
Other predictors of adjudicated symptomatic objectively confirmed recurrent VTE at 2 years including: gender
Measured: Inclusion
Other predictors of adjudicated symptomatic objectively confirmed recurrent VTE at 2 years including: obesity
Body Mass Index > 30 kg/m2
Measured: Inclusion
Other predictors of adjudicated symptomatic objectively confirmed recurrent VTE at 2 years including: D-Dimer
Measurement of the concentration of plasma D-dimer
Measured: Inclusion
Other predictors of adjudicated symptomatic objectively confirmed recurrent VTE at 2 years including: inherited or acquired thrombophilia
Number of Participants with inherited or acquired thrombophilia
Measured: Inclusion
Other predictors of adjudicated symptomatic objectively confirmed recurrent VTE at 2 years including: residual vein thrombosis
Number of Participants with residual vein thrombosis
Measured: Inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start11 Jun 2024
- Primary completionDec 2028 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Cohort study
- Masking
- None (open label)
- Enrolment
- 665 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06372730
- Sponsor's protocol ID
- 29BRC23.0161
- Other IDs
- 2023-A01566-39
- Acronym
- PRONOSPECT
- Status last verified
- Jun 2026
- First submitted
- 11 Mar 2024
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Residual Pulmonary Vascular Obstruction (RPVO) Index Computed With Ventilation/Perfusion SPECT/CT Imaging to Predict the Risk of Venous Thromboembolism (VTE) Recurrence in Patients With Pulmonary Embolism (PE)
- ClinicalTrials.gov ID
- NCT06372730
- Acronym / sponsor ID
- PRONOSPECT / 29BRC23.0161
- Conditions
- Pulmonary Embolism, Venous Thromboembolism
- Keywords
- venous thromboembolism recurrence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 665 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 11 Jun 2024 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 18 Apr 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.
Major risk after pulmonary embolism (PE) is recurrence, fatal in 10% of patients. Patients with PE can be stratified in 3 groups according to the risk of recurrence : very low risk, high risk or Intermediate risk. Little is known about this last group.
Anticoagulation is efficient to prevent recurrence but is currently not recommended for patient with an intermediate risk of recurrence.
Identifying risk factors of recurrent PE remains a major issue to identify sub-groups of patients who would require lifelong anticoagulation.
In 30-40% of cases, PE patients develop residual pulmonary vascular obstruction (RPVO), which has been found to be associated with an increased recurrence risk. This last observation was mostly reported in patients with unprovoked PE (patients with high risk of recurrence) and RPVO was measured using conventional planar lung scan.
In patients with an intermediate risk of recurrence, the impact of RPVO has been much less studied. In addition, the definition of RPVO was variable according to studies and correlation between RPVO burden and recurrence risk has not been clearly demonstrated. This might be explained by the inherent limitation of RPVO quantification using conventional planar imaging, which is only based on a visual estimation on 2-dimensional images.
Ventilation/Perfusion Single Photon Emission Computed Tomography (V/Q SPECT/CT) is a new method of scintigraphic image acquisition that offers the advantage of 3-dimensional imaging, enabling more accurate and reproducible quantification of RPVO.
The main hypothesis of this study is that in patients with PE at intermediate risk of recurrence, RPVO computed with V/Q SPECT/CT imaging may be an important predictor of recurrence.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cohort study
| Arm | Type | Receives |
|---|---|---|
| Patients with PE who have been treated with anticoagulant therapy for 3 to 6 uninterrupted months | Experimental | Other: Ventilation/Perfusion Single Photon Emission Computed Tomography (V/Q SPECT/CT)Patients who experienced an objectively proven PE who have been treated initially with anticoagulant therapy for 3 to 6 uninterrupted months (180 - 210 days) and for whom anticoagulation will not be prolonged. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients ≥ 18 years,
- who experienced an objectively proven PE,
- who have been treated initially with anticoagulant therapy for 3 to 6 uninterrupted months (180 - 210 days) and for whom anticoagulation will not be prolonged.
Key exclusion criteria (18 listed)
- Unwilling or unable to give written informed consent (protected adults, under tutorship or curatorship)
- Patients deprived of their liberty by a judicial or administrative decision, patients undergoing psychiatric care by virtue of Articles L. 3212-1 and L. 3213-1 who are not covered by the provisions of Article L. 1121-8 and patients admitted to a health or social establishment for purposes other than research
- No Social security affiliation
- Isolated DVT
- Pregnant women and parturients
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 |
|---|---|---|
| Ventilation/Perfusion Single Photon Emission Computed Tomography (V/Q SPECT/CT)All patients will undergo a V/Q SPECT/CT scan at inclusion. | Other | Patients with PE who have been treated with anticoagulant therapy for 3 to 6 uninterrupted months |
Primary outcome
Symptomatic recurrent venous thromboembolism (VTE), including objectively confirmed nonfatal symptomatic PE or proximal deep vein thrombosis or fatal PE during a 24-month follow-up after inclusion in the study
Time frame: From baseline to Month 24
In case of a suspected VTE or death during follow-up, the study personnel will collect related clinical data on the electronic case report form, and prepare an adjudication file, including symptoms, clinical notes, hospital discharge summary, and results of all diagnostic tests. All suspicion of VTE recurrence will be adjudicated blindly by an independent central Clinical Events Committee. To assess the primary objective, RPVO will be defined by a perfusion mismatched defect of at least 5% of the whole lung, corresponding to a segmental defect. SPECT imaging should not be used at inclusion and should not result in proposing prolonged anticoagulation. SPECT images will be numerically stored and interpretation will be later performed independently by two nuclear medicine physicians who will be blinded to clinical history and the patient's outcome. Any difference in interpretation will be resolved by consensus.
18 secondary outcomes
Adjudicated symptomatic objectively confirmed recurrent VTE during the follow-up period.
Time frame: From baseline to Month 24
Percentage of patients with RPVO (as defined by a perfusion defect > 5%) on V/Q SPECT/CT imaging at inclusion in the study.
Time frame: Inclusion
Different cut-offs of pulmonary vascular obstruction index will be evaluated to predict the risk of VTE recurrence at 2 years, by generating ROC curves
Time frame: Inclusion
Other predictors of adjudicated symptomatic objectively confirmed recurrent VTE at 2 years including: age
Time frame: Inclusion
The following score will be computed : HERDOO2 (Hyperpigmentation, Edema, Redness, D-Dimer, Obesity, Old)
Time frame: Inclusion
Potential predictors of RPVO including : demographics
Time frame: Inclusion
Symptomatic recurrent VTE during a 3 Months follow-up period in patients with suspicion of PE recurrence who has been left untreated based on a negative V/Q SPECT/CT scan
Time frame: 3 Months follow-up period after the suspicion of PE recurrence
Dyspnea index will be assessed using mMRC scale (Modified Medical Research Council)
Time frame: Inclusion and Month 6
Quality of life (QoL) will be assessed using PEmb-Qol (Pulmonary Embolism Quality of Life)
Time frame: Inclusion and Month 6
Number of Participants with chronic thromboembolic pulmonary hypertension (CTEPH).
Time frame: From baseline to Month 24
Mortality of all causes.
Time frame: From baseline to Month 24
Percentage of patients with RPVO (> 5%) on V/Q SPECT/CT imaging using Technegas and Krypton.
Time frame: Inclusion
The following score will be computed : PADIS-PE score.
Time frame: Inclusion
Other predictors of adjudicated symptomatic objectively confirmed recurrent VTE at 2 years including: gender
Time frame: Inclusion
Other predictors of adjudicated symptomatic objectively confirmed recurrent VTE at 2 years including: obesity
Time frame: Inclusion
Other predictors of adjudicated symptomatic objectively confirmed recurrent VTE at 2 years including: D-Dimer
Time frame: Inclusion
Other predictors of adjudicated symptomatic objectively confirmed recurrent VTE at 2 years including: inherited or acquired thrombophilia
Time frame: Inclusion
Other predictors of adjudicated symptomatic objectively confirmed recurrent VTE at 2 years including: residual vein thrombosis
Time frame: Inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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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.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ventilation/Perfusion Single Photon Emission Computed Tomography (V/Q SPECT/CT) in people with Pulmonary Embolism and Venous Thromboembolism, run by University Hospital, Brest at 13 sites 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 3 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pierre-Yves LE ROUX, Pr (+33298223327, pierre-yves.leroux@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptomatic recurrent venous thromboembolism (VTE), including objectively confirmed nonfatal symptomatic PE or proximal deep vein thrombosis or fatal PE during a 24-month follow-up after inclusion in the study (time frame: From baseline to Month 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jun 2026.