2024-518293-13-01招募中2 期
Ventilation/Perfusion PET/CT with Galligas and 68Ga-MAA for regional lung function assessment after pulmonary embolism
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Pulmonary vascular obstruction index (PVOI), expressed as a percentage of whole lung volume, on V/Q PET/CT imaging.
研究概览
简要总结
To assess the impact of PR on regional perfusion lung function with lung V/Q PET/CT imaging.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •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.
- •Patients who have a PembQol score ≥ 10% and whose total scores for the subgroups Q1 (dyspnea) and Q4 (impact of daily life) are ≥ 10%.
- •Patients planned to be randomized.
- •Abnormal conventional V/Q scan at V1
- •Give consent to participate to the EOLE study.
排除标准
- •Previsible inability to perform the effort test and/or PR
- •Cardiac insufficiency (unstable coronary artery disease)
- •Severe respiratory failure (long-term oxygen therapy, pulmonary hypertension)
- •Chronic dyspnea MMRC ≥ 2 before PE
- •Cardiac or respiratory rehabilitation in the previous year
- •Indication to urgent PR within 6 months at the time of inclusion
- •Life expectancy of less than 12 months
- •Inability to give consent
- •Patient under guardianship or curatorship
- •Patient deprived of liberty by an administrative or judicial decision
- •Patient has not social security affiliation or who don’t beneficiary of such social security
- •Presence of CTEPH according to international guidelines
- •Incapacity to perform the effort test
- •Effort test stopped because of hemodynamic intolerance
- •Cardiac failure discovered after PR work up
- •Patients treated for acute PE with anticoagulants for more than 8 months
- •Active cancer or in remission for less than two years
- •Dyspnea post – COVID due to parenchymal injuries
- •Post-COVID hyperventilation syndrome without pulmonary vascular perfusion sequelae
- •Physical or psychological inability to undertake PR
- •Isolated or more distal segmental PE
- •Neuro-muscular disease with PR contraindication.
结局指标
主要结局
Pulmonary vascular obstruction index (PVOI), expressed as a percentage of whole lung volume, on V/Q PET/CT imaging.
Pulmonary vascular obstruction index (PVOI), expressed as a percentage of whole lung volume, on V/Q PET/CT imaging.
次要结局
- Global lung function parameters - Dyspnea scores : MDP, Borg and MMRC
- V/Q PET/CT regional lung functional volumes : - pulmonary vascular obstruction index
- V/Q PET/CT regional lung functional volumes : - pulmonary ventilation impairment index
- Global lung function parameters - Respiratory functional tests (FVC, FEV, FVC-FEV) and TLco
- Global lung function parameters - Cardio Pulmonary Exercise Tes
- Global lung function parameters - Cycloergometer endurance tes
- Global lung function parameters - 6MWT
- Quality of life - PEmb-QoL score
研究者
Clinical Trial Manager
Scientific
Centre Hospitalier Regional Et Universitaire De Brest
研究点 (1)
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