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)

NCT06372730 | Recruiting DMC

• 2 other identifiers: 29BRC23.01612023-A01566-39
• Study Type: interventional
• Target: 665
• Locations: 1 country
• Sites: 13

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.

Conditions

Pulmonary Embolism; Venous Thromboembolism

Keywords

venous thromboembolism recurrence

Outcome Measures

Primary Outcomes (1)

• 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.

  From baseline to Month 24

Secondary Outcomes (18)

• Adjudicated symptomatic objectively confirmed recurrent VTE during the follow-up period.

  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.

  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

  Inclusion

• Other predictors of adjudicated symptomatic objectively confirmed recurrent VTE at 2 years including: age

  Inclusion

• The following score will be computed : HERDOO2 (Hyperpigmentation, Edema, Redness, D-Dimer, Obesity, Old)

  Inclusion

Study Arms (1)

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.

Other: Ventilation/Perfusion Single Photon Emission Computed Tomography (V/Q SPECT/CT)

Interventions

Ventilation/Perfusion Single Photon Emission Computed Tomography (V/Q SPECT/CT) OTHER

All patients will undergo a V/Q SPECT/CT scan at inclusion.

Patients with PE who have been treated with anticoagulant therapy for 3 to 6 uninterrupted months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (13)

CHU Amiens

Amiens, France, 80054, France

ACTIVE NOT RECRUITING

CHU Angers

Angers, France, 49933, France

NOT YET RECRUITING

CHU Brest

Brest, France, 29609, France

RECRUITING

Hôpital Louis MourierAP-HP

Colombes, France, 92700, France

NOT YET RECRUITING

CHD Vendée - La Roche sur Yon

La Roche-sur-Yon, France, 85925, France

RECRUITING

Kremlin-Bicêtre AP-HP

Le Kremlin-Bicêtre, France, 94270, France

NOT YET RECRUITING

CH Les Sables d'Olonne

Les Sables-d'Olonne, France, 85340, France

NOT YET RECRUITING

Hegp Ap-Hp

Paris, France, 75015, France

NOT YET RECRUITING

CH Quimper

Quimper, France, 29000, France

RECRUITING

CHU St-Etienne

Saint-Etienne, France, 42055, France

NOT YET RECRUITING

CHIC Toulon

Toulon, France, 83056, France

NOT YET RECRUITING

HIA Toulon

Toulon, France, 83800, France

NOT YET RECRUITING

CHU Toulouse

Toulouse, France, 31059, France

NOT YET RECRUITING

MeSH Terms

Conditions

Pulmonary Embolism; Venous Thromboembolism

Interventions

Ventilation

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thromboembolism

Intervention Hierarchy (Ancestors)

Environment, Controlled; Environment; Environment and Public Health

Central Study Contacts

Pierre-Yves LE ROUX, Pr

CONTACT

+33298223327; pierre-yves.leroux@chu-brest.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cohort study

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: April 18, 2024
• Study Start: June 11, 2024
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: November 1, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning five years and ending fifteen years following the final study report completion.
• Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

Locations

FR (13)