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

Sponsor

Assistance Publique Hopitaux De Marseille (Other)

Overall Status

Unknown status

CT.gov ID

NCT04126616

Collaborator

(none)

Enrollment

Location

Arms

24.6

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease (COPD)	Diagnostic Test: chest Magnetic Resonance Imaging (MRI) using Gadolinium-based contrast agent	N/A

Detailed Description

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Oct 15, 2019

Anticipated Primary Completion Date :

Nov 1, 2020

Anticipated Study Completion Date :

Nov 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: patients with COPD and PH	Diagnostic Test: chest Magnetic Resonance Imaging (MRI) using Gadolinium-based contrast agent chest MRI will be performed at rest and after moderate exercise
Active Comparator: patients with COPD without PH	Diagnostic Test: chest Magnetic Resonance Imaging (MRI) using Gadolinium-based contrast agent chest MRI will be performed at rest and after moderate exercise
Active Comparator: healthy subjects	Diagnostic Test: chest Magnetic Resonance Imaging (MRI) using Gadolinium-based contrast agent chest MRI will be performed at rest and after moderate exercise

Arm

Intervention/Treatment

Experimental: patients with COPD and PH

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

chest MRI will be performed at rest and after moderate exercise

Active Comparator: patients with COPD without PH

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

chest MRI will be performed at rest and after moderate exercise

Active Comparator: healthy subjects

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

chest MRI will be performed at rest and after moderate exercise

Outcome Measures

Primary Outcome Measures

Pulmonary blood flow variation from rest to exercise [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assistance Publique Hôpitaux de Marseille	Marseille		France

Sponsors and Collaborators

Assistance Publique Hopitaux De Marseille

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Assistance Publique Hopitaux De Marseille

ClinicalTrials.gov Identifier:

NCT04126616

Other Study ID Numbers:

2019-14

First Posted:

Oct 15, 2019

Last Update Posted:

Nov 8, 2019

Last Verified:

Oct 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Lung Diseases

Lung Diseases, Obstructive

Pulmonary Disease, Chronic Obstructive

Study Results

No Results Posted as of Nov 8, 2019