Pulmonary Vascular Impairment in Chronic Obstructive Pulmonary Disease (COPD) Assessed by MRI (PulmoVasc)
Chronic Obstructive Pulmonary Disease (COPD) is a highly prevalent pulmonary disease providing major morbidity and mortality. Bronchial obstruction is the cornerstone in assessment of the disease whereas associated pulmonary vascular disease remains poorly known.
Improving knowledge on pulmonary vascular adaptive skills in COPD patients could allow for better understanding disease exacerbations, evolution towards chronic pulmonary hypertension (PH) and therapeutics to be offered to the patients.
Magnetic resonance imaging (MRI) is an innovative and non-invasive tool capable of pulmonary vascular evaluation. This work aims at identifying pulmonary vascular impairment in COPD patients using functional MRI.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Chronic Obstructive Pulmonary Disease (COPD) is a highly prevalent pulmonary disease providing major morbidity and mortality. Bronchial obstruction is the cornerstone in assessment of the disease whereas associated pulmonary vascular disease remains poorly known.
However, it has been shown that emphysema, frequently observed in COPD, contains major vascular lesions. Alteration of pulmonary vascularisation have been found during exacerbation of the disease.
Moreover, it is well established that such vascular lesions form the substrate for endothelial dysfunction, expressed as an impairment of vascular adaptation during exercise, and evolving towards chronic pulmonary hypertension (PH). Owing to its severe effects on the right-sided heart, it signs a pejorative turn in patients' survival and quality of life.
Finally, COPD patients' phenotypes are very heterogeneous and the clinical response to PH treatments is variable; while some get a benefit, others are counter-indicated due to adverse effects.
Improving knowledge on pulmonary vascular adaptive skills in COPD patients could allow for better understanding disease exacerbations, evolution towards PH and therapeutics to be offered to the patients.
This area of research remains widely unknown because of the lack of simple tools to assess pulmonary vascularisation which could be used in clinical routine. Magnetic resonance imaging (MRI) is an innovative and non-invasive tool capable of pulmonary vascular evaluation. This work aims at identifying pulmonary vascular impairment in COPD patients using functional MRI.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Marseille, France
- Assistance Publique Hôpitaux de Marseille
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 40-70
- Diagnosed with COPD
- Emphysema on chest CT
- FEV1 between 35 and 80 %
- Screened for PH by echocardiography
Exclusion Criteria:
- side effect for exercise
- side effect for MRI and contrast agent injection
- Pregnancy or breastfeeding
- Refusing to be informed of the discovery of an anomaly on chest MRI
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: healthy subjects
|
chest MRI will be performed at rest and after moderate exercise
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Experimental: patients with COPD and PH
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chest MRI will be performed at rest and after moderate exercise
|
|
Active Comparator: patients with COPD without PH
|
chest MRI will be performed at rest and after moderate exercise
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pulmonary blood flow variation from rest to exercise
Time Frame: 4 hours
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Pulmonary blood flow will be measured with dynamic contrast-enhancement MRI at rest and after moderate exercise.
Relative variation is the primary outcome.
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4 hours
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Chronic Disease
- Disease Attributes
- Respiratory Tract Diseases
- Lung Diseases
- Lung Diseases, Obstructive
- Pathological Conditions, Signs and Symptoms
- Pulmonary Disease, Chronic Obstructive
- Diagnostic Techniques and Procedures
- Diagnosis
- Tomography
- Diagnostic Imaging
- Magnetic Resonance Imaging
Other Study ID Numbers
- 2019-14
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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