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

NCT ID: NCT04126616

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-15
• Study Completion Date: 2025-10-15

Brief Summary

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.

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

patients with COPD and PH

Group Type: EXPERIMENTAL

chest Magnetic Resonance Imaging (MRI) using Gadolinium-based contrast agent

Intervention Type: DIAGNOSTIC_TEST

chest MRI will be performed at rest and after moderate exercise

patients with COPD without PH

Group Type: ACTIVE_COMPARATOR

chest Magnetic Resonance Imaging (MRI) using Gadolinium-based contrast agent

Intervention Type: DIAGNOSTIC_TEST

chest MRI will be performed at rest and after moderate exercise

healthy subjects

Group Type: ACTIVE_COMPARATOR

chest Magnetic Resonance Imaging (MRI) using Gadolinium-based contrast agent

Intervention Type: DIAGNOSTIC_TEST

chest MRI will be performed at rest and after moderate exercise

Interventions

chest Magnetic Resonance Imaging (MRI) using Gadolinium-based contrast agent

chest MRI will be performed at rest and after moderate exercise

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Assistance Publique Hôpitaux de Marseille

Marseille, , France

Countries

France

Other Identifiers

2019-14

Identifier Type: -

Identifier Source: org_study_id