Pulmonary Vascular Impairment in Chronic Obstructive Pulmonary Disease (COPD) Assessed by MRI (PulmoVasc)
Primary Purpose
Chronic Obstructive Pulmonary Disease (COPD)
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
chest Magnetic Resonance Imaging (MRI) using Gadolinium-based contrast agent
Sponsored by
About this trial
This is an interventional diagnostic trial for Chronic Obstructive Pulmonary Disease (COPD)
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
Sites / Locations
- Assistance Publique Hôpitaux de MarseilleRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
patients with COPD and PH
patients with COPD without PH
healthy subjects
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04126616
First Posted
October 9, 2019
Last Updated
November 7, 2019
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT04126616
Brief Title
Pulmonary Vascular Impairment in Chronic Obstructive Pulmonary Disease (COPD) Assessed by MRI
Acronym
PulmoVasc
Official Title
Pulmonary Vascular Impairment in Chronic Obstructive Pulmonary Disease (COPD) Assessed by MRI
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 15, 2019 (Actual)
Primary Completion Date
November 2020 (Anticipated)
Study Completion Date
November 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
patients with COPD and PH
Arm Type
Experimental
Arm Title
patients with COPD without PH
Arm Type
Active Comparator
Arm Title
healthy subjects
Arm Type
Active Comparator
Intervention Type
Diagnostic Test
Intervention Name(s)
chest Magnetic Resonance Imaging (MRI) using Gadolinium-based contrast agent
Intervention Description
chest MRI will be performed at rest and after moderate exercise
Primary Outcome Measure Information:
Title
Pulmonary blood flow variation from rest to exercise
Description
Pulmonary blood flow will be measured with dynamic contrast-enhancement MRI at rest and after moderate exercise. Relative variation is the primary outcome.
Time Frame
4 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thibaut Capron
Email
thibaut.capron@ap-hm.fr
Facility Information:
Facility Name
Assistance Publique Hôpitaux de Marseille
City
Marseille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thibaut Capron
12. IPD Sharing Statement
Learn more about this trial
Pulmonary Vascular Impairment in Chronic Obstructive Pulmonary Disease (COPD) Assessed by MRI
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