Assessing lung function after pulmonary embolism using advanced imaging techniques

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of ventilation/perfusion PET/CT imaging with Galligas and 68Ga-MAA in patients who have experienced pulmonary embolism and continue to suffer from dyspnea despite anticoagulant treatment. The study is part of a larger trial assessing pulmonary rehabilitation's impact on quality of life in these patients. Participants will undergo advanced imaging to assess regional lung function, which may help tailor rehabilitation strategies. The trial is multicenter and randomized, ensuring a robust approach to data collection and analysis.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patient included in the RAMBO study, whose inclusion criteria are: 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

Exclusion Criteria:

* Non inclusion criteria of the RAMBO trial:
* Previsible inability to perform the effort test and/or PR
* Presence of CTEPH according to international guidelines
* 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.
* 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

After initial PR work up, patients with following criteria cannot be included:

* Incapacity to perform the effort test
* Effort test stopped because of hemodynamic intolerance
* Cardiac failure discovered after PR work up

Where it's running

• LEROUX Pierre-Yves
  Brest, France Recruiting

Study contacts

• Study coordinator: Pierre-Yves LE ROUX
• Email: pierre-yves.leroux@chu-brest.fr
• Phone: +332 98 22 31 17

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.