Clinical trial NCT06372730: 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)
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulmonary Embolism
Venous Thromboembolism
Keywords: venous thromboembolism recurrence
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2024-04-18
Enrollment: 665
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Cohort study
Primary purpose: PREVENTION

Brief 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.

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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,parturients women
* Other indication for anticoagulant therapy (e.g. atrial fibrillation, mechanic valve)
* 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) or Recurrent unprovoked PE
* PE provoked by a major transient risk factor

Primary outcomes:
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
timeFrame: From baseline to Month 24
Secondary outcomes:
measure: Adjudicated symptomatic objectively confirmed recurrent VTE during the follow-up period.
timeFrame: From baseline to Month 24
measure: Percentage of patients with RPVO (as defined by a perfusion defect > 5%) on V/Q SPECT/CT imaging at inclusion in the study.
timeFrame: Inclusion
measure: 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
timeFrame: Inclusion
measure: Other predictors of adjudicated symptomatic objectively confirmed recurrent VTE at 2 years including: age
timeFrame: Inclusion
measure: The following score will be computed : HERDOO2 (Hyperpigmentation, Edema, Redness, D-Dimer, Obesity, Old)
timeFrame: Inclusion
measure: Potential predictors of RPVO including : demographics
timeFrame: Inclusion
measure: 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
timeFrame: 3 Months follow-up period after the suspicion of PE recurrence
measure: Dyspnea index will be assessed using mMRC scale (Modified Medical Research Council)
timeFrame: Inclusion and Month 6
measure: Quality of life (QoL) will be assessed using PEmb-Qol (Pulmonary Embolism Quality of Life)
timeFrame: Inclusion and Month 6
measure: Number of Participants with chronic thromboembolic pulmonary hypertension (CTEPH).
timeFrame: From baseline to Month 24
measure: Mortality of all causes.
timeFrame: From baseline to Month 24
measure: Percentage of patients with RPVO (> 5%) on V/Q SPECT/CT imaging using Technegas and Krypton.
timeFrame: Inclusion
measure: The following score will be computed : PADIS-PE score.
timeFrame: Inclusion
measure: Other predictors of adjudicated symptomatic objectively confirmed recurrent VTE at 2 years including: gender
timeFrame: Inclusion
measure: Other predictors of adjudicated symptomatic objectively confirmed recurrent VTE at 2 years including: obesity
timeFrame: Inclusion
measure: Other predictors of adjudicated symptomatic objectively confirmed recurrent VTE at 2 years including: D-Dimer
timeFrame: Inclusion
measure: Other predictors of adjudicated symptomatic objectively confirmed recurrent VTE at 2 years including: inherited or acquired thrombophilia
timeFrame: Inclusion
measure: Other predictors of adjudicated symptomatic objectively confirmed recurrent VTE at 2 years including: residual vein thrombosis
timeFrame: Inclusion
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
city: Angers
country: France
facility: CHU Angers
city: Brest
country: France
facility: CHU Brest
city: Colombes
country: France
facility: Hôpital Louis MourierAP-HP
city: La Roche-sur-Yon
country: France
facility: CHD Vendée - La Roche sur Yon
city: Le Kremlin-Bicêtre
country: France
facility: Kremlin-Bicêtre AP-HP
city: Les Sables-d'Olonne
country: France
facility: CH Les Sables d'Olonne
city: Paris
country: France
facility: Hegp Ap-Hp
city: Quimper
country: France
facility: CH Quimper
city: Saint-Étienne
country: France
facility: CHU St-Etienne
city: Toulon
country: France
facility: CHIC Toulon
city: Toulon
country: France
facility: HIA Toulon
city: Toulouse
country: France
facility: CHU Toulouse
Study officials:
References: