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

NCT04126616 | Completed

• 1 other identifier: 2019-14
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Outcome Measures

Primary Outcomes (1)

• Pulmonary blood flow variation from rest to exercise

  Pulmonary blood flow will be measured with dynamic contrast-enhancement MRI at rest and after moderate exercise. Relative variation is the primary outcome.

  4 hours

Study Arms (3)

patients with COPD and PH

EXPERIMENTAL

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

patients with COPD without PH

ACTIVE COMPARATOR

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

healthy subjects

ACTIVE COMPARATOR

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

Interventions

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

chest MRI will be performed at rest and after moderate exercise

healthy subjects; patients with COPD and PH; patients with COPD without PH

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 40-70
• Diagnosed with COPD
• Emphysema on chest CT
• FEV1 between 35 and 80 %
• Screened for PH by echocardiography

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hôpitaux de Marseille

Marseille, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2019
• First Posted: October 15, 2019
• Study Start: October 15, 2019
• Primary Completion: October 15, 2025
• Study Completion: October 15, 2025
• Last Updated: November 19, 2025

Record last verified: 2025-11

Locations

FR (1)