Status:
ACTIVE_NOT_RECRUITING
Phenotype Identification Based on Multimodal MRI Analysis of Patients With Bronchial Obstructive Diseases
Lead Sponsor:
University Hospital, Bordeaux
Conditions:
Asthma Copd
Eligibility:
All Genders
40-70 years
Phase:
NA
Brief Summary
The hypothesis is that pulmonary and cardiac proton MRI allows phenotyping of patients with bronchial obstruction by cluster analysis based on quantitative multimodal imaging of bronchi, pulmonary ves...
Detailed Description
Bronchial obstructive diseases such as asthma and chronic obstructive pulmonary disease (COPD) are very common and represent a major public health problem. The distinction between these two diseases i...
Eligibility Criteria
Inclusion
- Man or woman aged between 40 and 70 years.
- Having benefited under the current care of spirometry showing FEV / FVC pre-bronchodilation \<0.70 at steady state (i.e., without exacerbation from at least 4 weeks).
- Having a diagnosis of asthma according to GINA 2019 without smoking restrictions or COPD according to GOLD 2019 but unrestricted to any level of bronchial reversibility to bronchodilator established by the pulmonologist.
- On stable cardiopulmonary medications for at least 4 weeks
- Having given his written informed consent.
Exclusion
- Subject deprived of liberty by judicial or administrative decision.
- Major protected by law.
- Subject not affiliated to a social security scheme, whether or not the beneficiary of such a regime.
- Pregnant or breastfeeding women
- Inability to complete the Questionnaire SF-36 and SGQLQ.
- Subject in times of exclusion in relation to another protocol.
- History of pulmonary fibrosis, primary pulmonary hypertension and cystic fibrosis.
- History of lung resection (referred to oncological or volume reduction)
- History of cancer except skin cancer (squamous and Basal) under 5 years
- History of chest radiation
- Pacemaker carrier subject or implantable defibrillator, intraocular metallic foreign body, metal clip intracranial, heart valve prosthesis kind Starr-Edwards pre-6000, or biomedical insulin pump type device, Neurostimulator or cochlear implant, Metal patches.
- Subject claustrophobic or unable to stay elongate during 30 minutes.
- Subject with a waist circumference greater than 200 cm.
- Occurrence of an exacerbation between the FE and MRI
- Uninterpretable MRI
Key Trial Info
Start Date :
August 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04341701
Start Date
August 5 2021
End Date
March 30 2024
Last Update
February 2 2024
Active Locations (6)
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1
Centre hospitalier de la Côte Basque
Bayonne, France, 64100
2
Clinique Saint Augustin
Bordeaux, France, 33000
3
Centre Médical Toki Eder
Cambo-les-Bains, France, 64250
4
Hôpital Le Cluzeau - CHU de Limoges
Limoges, France, 87000