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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.
Ventilation/Perfusion (V/Q) PET/CT is a novel imaging modality for the assessment of regional lung function. The same carrier molecules as conventional V/Q imaging are used, but they are labeled with 68Gallium, a ß+ isotope, instead of 99mTc, allowing acquisition of images with PET technology.
The EOLE study is an ancillary pilot study of the RAMBO trial, in which patients will benefit, in addition to the extensive work up scheduled as per study protocol, from a V/Q PET/CT scan before and after PR. The aim of the study is to assess the impact of PR on regional lung function with lung V/Q PET/CT imaging.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients undergoing a Ventilation/Perfusion PET/CT at inclusion and 3 months later | Experimental | EOLE is an ancillary study which selects patients included in the RAMBO study. The RAMBO study is a 2-arm-parallel study which patients included in one arm will undergo a 3-month pulmonary rehabilitation, and the patients included in the other arm won't. The EOLE study will include specific patients in both arms of the RAMBO study, and all of the participants will undergo a PET/CT scan at the inclusion and 3 months later. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ventilation/Perfusion PET/CT with Galligas and 68Ga-MAA | Procedure | 32 patients will undergo a Ventilation/Perfusion PET/CT with Galligas and 68Ga-MAA at the inclusion and 3 months later. |
| Measure | Description | Time Frame |
|---|---|---|
| Pulmonary vascular obstruction index (PVOI) on V/Q PET/CT imaging. | Expressed as a percentage of whole lung | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pulmonary ventilation impairment index on V/Q PET/CT imaging. | Expressed as a percentage of whole lung | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
After initial PR work up, patients with following criteria cannot be included:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pierre-Yves LE ROUX | Contact | +332 98 22 31 17 | pierre-yves.leroux@chu-brest.fr | |
| Pierre-Yves SALAUN | Contact | +332 98 22 31 17 | pierre-yves.salaun@chu-brest.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LEROUX Pierre-Yves | Recruiting | Brest | 29200 | France |
All collected data that underlie results in a publication
Data will be available beginning five years and ending fifteen years following the final study report completion
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.
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| ID | Term |
|---|---|
| D011655 | Pulmonary Embolism |
| D004417 | Dyspnea |
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
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| ID | Term |
|---|---|
| D014691 | Ventilation |
| ID | Term |
|---|---|
| D004780 | Environment, Controlled |
| D004777 | Environment |
| D004778 | Environment and Public Health |
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EOLE is an ancillary study which selects patients included in the RAMBO study. The RAMBO study is a 2-arm-parallel study which patients included in one arm will undergo a 3-month pulmonary rehabilitation, and the patients included in the other arm won't. The EOLE study will include patients in both arms of the RAMBO study. All participants will undergo a PET/CT scan at inclusion and at 3 months.
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| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012120 | Respiration Disorders |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |