GRAPHITE for Pulmonary embolism

Inclusion criteria

• {"criterion_text":"-Age ≥ 18 years"}
• {"criterion_text":"-Patient treated with at least 3 months and up to 8 months of anticoagulation for an acute symptomatic PE diagnosed according the ESC and ACCP guidelines."}
• {"criterion_text":"-Patients who have a PembQol score ≥ 10% and whose total scores for the subgroups Q1 (dyspnea) and Q4 (impact of daily life) are ≥ 10%."}
• {"criterion_text":"-Patients planned to be randomized."}
• {"criterion_text":"-Abnormal conventional V/Q scan at V1"}
• {"criterion_text":"-Give consent to participate to the EOLE study."}

Exclusion criteria

• {"criterion_text":"- Previsible inability to perform the effort test and/or PR"}
• {"criterion_text":"- Cardiac insufficiency (unstable coronary artery disease)"}
• {"criterion_text":"- Severe respiratory failure (long-term oxygen therapy, pulmonary hypertension)"}
• {"criterion_text":"- Chronic dyspnea MMRC ≥ 2 before PE"}
• {"criterion_text":"- Cardiac or respiratory rehabilitation in the previous year"}
• {"criterion_text":"- Indication to urgent PR within 6 months at the time of inclusion"}
• {"criterion_text":"- Life expectancy of less than 12 months"}
• {"criterion_text":"- Inability to give consent"}
• {"criterion_text":"- Patient under guardianship or curatorship"}
• {"criterion_text":"- Patient deprived of liberty by an administrative or judicial decision"}
• {"criterion_text":"- Patient has not social security affiliation or who don’t beneficiary of such social security"}
• {"criterion_text":"- Presence of CTEPH according to international guidelines"}
• {"criterion_text":"- Incapacity to perform the effort test"}
• {"criterion_text":"- Effort test stopped because of hemodynamic intolerance"}
• {"criterion_text":"- Cardiac failure discovered after PR work up"}
• {"criterion_text":"- Patients treated for acute PE with anticoagulants for more than 8 months"}
• {"criterion_text":"- Active cancer or in remission for less than two years"}
• {"criterion_text":"- Dyspnea post – COVID due to parenchymal injuries"}
• {"criterion_text":"- Post-COVID hyperventilation syndrome without pulmonary vascular perfusion sequelae"}
• {"criterion_text":"- Physical or psychological inability to undertake PR"}
• {"criterion_text":"- Isolated or more distal segmental PE"}
• {"criterion_text":"- Neuro-muscular disease with PR contraindication."}

Primary endpoints

• {"endpoint_text":"-Pulmonary vascular obstruction index (PVOI), expressed as a percentage of whole lung volume, on V/Q PET/CT imaging.","definition_or_measurement_approach":"Measured on V/Q PET/CT imaging and expressed as a percentage of whole lung volume."}

Secondary endpoints

• {"endpoint_text":"-V/Q PET/CT regional lung functional volumes : - pulmonary vascular obstruction index","definition_or_measurement_approach":"Regional lung functional volumes assessed by V/Q PET/CT; includes pulmonary vascular obstruction index measured by V/Q PET/CT."}
• {"endpoint_text":"-V/Q PET/CT regional lung functional volumes : - pulmonary ventilation impairment index","definition_or_measurement_approach":"Regional ventilation impairment index assessed by V/Q PET/CT."}
• {"endpoint_text":"-Global lung function parameters - Dyspnea scores : MDP, Borg and MMRC","definition_or_measurement_approach":"Dyspnea assessed using MDP, Borg and MMRC scores."}
• {"endpoint_text":"-Global lung function parameters - Respiratory functional tests (FVC, FEV, FVC-FEV) and TLco","definition_or_measurement_approach":"Respiratory functional tests including FVC, FEV, FVC-FEV and TLco."}
• {"endpoint_text":"-Global lung function parameters - Cardio Pulmonary Exercise Tes","definition_or_measurement_approach":"Cardio-pulmonary exercise testing parameters."}
• {"endpoint_text":"-Global lung function parameters - Cycloergometer endurance tes","definition_or_measurement_approach":"Cycloergometer endurance testing parameters."}
• {"endpoint_text":"-Global lung function parameters - 6MWT","definition_or_measurement_approach":"Six-minute walk test distance/performance."}
• {"endpoint_text":"-Quality of life - PEmb-QoL score","definition_or_measurement_approach":"Quality of life measured using the PEmb-QoL questionnaire/score."}

France

Latest Decision Or Authorization Date

19-02-2026

Number Of Sites

1

Number Of Participants

32

Primary sponsor

Full Name

Centre Hospitalier Regional Et Universitaire De Brest

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France