An interventional study of MRI in Asthma Copd, sponsored by University Hospital, Bordeaux. Active, not recruiting at 6 sites in France. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-02-02.
Sponsored by University Hospital, Bordeaux · Not applicable, Interventional, and Diagnostic
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 vessels, pulmonary parenchyma, right and left ventricular function, myocardial fibrosis and pulmonary arterial pressure.
Such imaging will also offer the advantage of being non-irradiating and without contrast products, which will ultimately allow CT to be replaced by MRI in the follow-up of bronchial obstructive patients, thus avoiding the risks associated with repeated exposure to ionizing radiation.
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 is sometimes difficult. In each of these diseases, several clinical phenotypes or biological endotypes have been defined. For example, frequent exacerbating patients and / or hypereosinophilic patients are present in both diseases. In the severe states, cardiovascular comorbidities are the most frequent comorbidities and alter the prognosis.
In these chronic obstructive patients, computed tomography (CT) allows a multimodal analysis of the bronchial wall, the lung parenchyma and pulmonary vessels. CT also allows a score analysis of coronary plaques. However, irradiation is significant and increases with repeated examinations. CT does not allow a comprehensive analysis of cardiac function, or an estimate of pulmonary artery pressure.
Magnetic Resonance Imaging (MRI) is a proton non-ionizing alternative to CT, in particular when using 3D ultra-short echo-time (UTE) sequences. These 3D-UTE sequences decrease the effects of magnetic susceptibility and provide morphological and morphometric information on bronchi and lung comparable to those obtained by CT. Moreover, dedicated sequences add functional information on bronchi. Heart MRI allows more analyses, such as right and left ventricular systolic functions, an indirect estimate of pulmonary arterial pressure and the amount of diffuse myocardial fibrosis.
Our project aims to identify morphological phenotypes through the pulmonary and heart MRI in patients with obstructive lung disease
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University Hospital, Bordeaux is the lead sponsor of 783 studies on the registry; 188 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
COPD according to GOLD 2019 but unrestricted to any level of bronchial reversibility established by the pulmonologist
Procedure: MRI
asthma according to GINA 2019 but without any smoking restriction
Procedure: MRI
The procedure to study lung and heart MRI, performed on a 1.5T magnet (Siemens), without any injection or inhalation of contrast agent
Determine the number of the clusters
Number of the clusters will be defined using principal component analysis and dendrogram, based on the multimodal lung and heart MRI analysis
Time frame: Day 30
Determine the Quality of the clusters
Quality of the clusters will be defined using Dunn index and non-hierarchical analysis based on the multimodal lung and heart MRI analysis
Time frame: Day 30
Assessment of age
Time frame: Day 1
Assessment of sexe
Time frame: Day 1
Assessment of tobacco consumption
Time frame: Day 1
Assessment of disease duration
Time frame: Day 1
Evaluation score of SF-36 questionnaire
Determine the quality of life. SF36: 36-Item Short Form health survey Minimum = 0 and maximum = 100 Higher score means better outcome
Time frame: Day 1
Evaluation with St Georges Quality of Life Questionnaire
Determine the quality of life. Minimum = 0 and maximum = 100 Higher score means worse outcome
Time frame: Day 30
Evaluation of comorbidities
The presence of various comorbidities will be checked in a yes/No manner : * rhinitis * sinusitis * nasal polyposis * gastroesophageal reflux * obstructive sleep apnea * depression * anxiety * allery * heart failure (Left or Right) * hypertension * myocardial infarction * stroke * arteriopathy * arythmia * diabetis * dyslipidaemia * obesity * denutrition * osteoporosis
Time frame: Day 1
Determine of Forced Expiratory Volume in one sec (FEV-1) during spirometry before and after bronchodilator
Assessment of FEV-1/FVC during spirometry before and after bronchodilator
Time frame: day 1
Determine of Forced Vital Capacity (FVC) during spirometry before and after bronchodilator
Assessment of FEV-1/FVC during spirometry before and after bronchodilator
Time frame: day 1
Determine of slow Vital Capacity (VC) during spirometry before and after bronchodilator
Time frame: day 1
Determine of Total Lung Capacity (TLC) during spirometry before and after bronchodilator
Time frame: day 1
Determine of Functional Residual Capacity (FRC) during spirometry before and after bronchodilator
Time frame: day 1
Determine of Residual Volume (RV) during spirometry before and after bronchodilator
Time frame: day 1
Determine of Carbon monoxide transfer capacity (TLCO)
Time frame: day 1
Determine the value of blood heamoglobin
Time frame: day 1
Determine the value of blood eosinophils
Time frame: day 1
Determine the value of blood C-reactive protein
Time frame: day 1
Determine the value of blood B-type natriuretic peptide
Time frame: day 1
Determine the value of blood total IgE at
Time frame: day 1
Determine the value of blood total IgE
Time frame: day 1
Plan to share: No
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This study is active, not recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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University Hospital, Bordeaux