Pulmonary Vascular Impairment in Chronic Obstructive Pulmonary Disease (COPD) Assessed by MRI

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2020

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.

Interventions

  • Diagnostic Test: chest Magnetic Resonance Imaging (MRI) using Gadolinium-based contrast agent
    • chest MRI will be performed at rest and after moderate exercise

Arms, Groups and Cohorts

  • Experimental: patients with COPD and PH
  • Active Comparator: patients with COPD without PH
  • Active Comparator: healthy subjects

Clinical Trial Outcome Measures

Primary Measures

  • Pulmonary blood flow variation from rest to exercise
    • Time Frame: 4 hours
    • Pulmonary blood flow will be measured with dynamic contrast-enhancement MRI at rest and after moderate exercise. Relative variation is the primary outcome.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Assistance Publique Hopitaux De Marseille
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Thibaut Capron, thibaut.capron@ap-hm.fr

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