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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

— PulmoVasc  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04126616
• Other study ID #: 2019-14
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2019
• Est. completion date: November 2021

Study information

• Verified date: October 2019
• Source: Assistance Publique Hopitaux De Marseille
• Contact: Thibaut Capron
• Email: thibaut.capron[@]ap-hm.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 2021
• Est. primary completion date: November 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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

Locations

Country	Name	City	State
France	Assistance Publique Hôpitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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