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New treatment option for Pulmonary Embolism
Official title Ventilation/Perfusion PET/CT With Galligas and 68Ga-MAA for Regional Lung Function Assessment After Pulmonary Embolism
ClinicalTrials.gov ID: NCT05103670
What this study is testing
- What it's testing
- In patients with pulmonary embolism (PE), after three or six months of anticoagulation, persistent dyspnea and impairment of quality of life are observed in at least 30% of cases. The "RAMBO" trial is a French academic, multicenter, randomized (1:1 ratio), parallel arm, controlled, that aimed to assess the efficacy of pulmonary rehabilitation (PR) on the quality of life in patients with an acute symptomatic PE treated with anticoagulant therapy during at least 3 months and who present an impairment of quality of life and/or persistent dyspnea despite anticoagulant therapy.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99
You may be able to join if
- Patient included in the RAMBO study, whose are: Age ≥ 18 years; Patient treated with at least 3 months and up to 8 months of anticoagulation for an...
- Patients planned to be assigned by chance
- Abnormal conventional V/Q scan at V1
- Give consent to participate to the EOLE study
You likely can't join if
- 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
See the full eligibility criteria
- Patient included in the RAMBO study, whose 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 planned to be assigned by chance
- Abnormal conventional V/Q scan at V1
- Give consent to participate to the EOLE study
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Brest, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brest, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.