Chronic Obstructive Pulmonary Disease (COPD)PulmoVascNCT04126616
Pulmonary Vascular Impairment in Chronic Obstructive Pulmonary Disease (COPD) Assessed by MRI
A study testing chest Magnetic Resonance Imaging (MRI) using Gadolinium-based contrast agent in people with Chronic Obstructive Pulmonary Disease (COPD), run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- chest Magnetic Resonance Imaging (MRI) using Gadolinium-based contrast agent
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 15 Oct 2019to 15 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 40-70
- Diagnosed with COPD
- Emphysema on chest CT
- FEV1 between 35 and 80 %
- Screened for PH by echocardiography
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- chest Magnetic Resonance Imaging (MRI) using Gadolinium-based contrast agent
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chest Magnetic Resonance Imaging (MRI) using Gadolinium-based contrast agentDiagnostic test
chest MRI will be performed at rest and after moderate exercise
| Study group | Role | What they receive |
|---|---|---|
| patients with COPD and PH | Experimental | Not described Receives: Diagnostic Test: chest Magnetic Resonance Imaging (MRI) using Gadolinium-based contrast agent |
| patients with COPD without PH | Active comparator | Not described Receives: Diagnostic Test: chest Magnetic Resonance Imaging (MRI) using Gadolinium-based contrast agent |
| healthy subjects | Active comparator | Not described Receives: Diagnostic Test: chest Magnetic Resonance Imaging (MRI) using Gadolinium-based contrast agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2019
- Study start15 Oct 2019
- Primary completion15 Oct 2025
- Study completion15 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04126616
- Sponsor's protocol ID
- 2019-14
- Acronym
- PulmoVasc
- Status last verified
- Nov 2025
- First submitted
- 9 Oct 2019
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Vascular Impairment in Chronic Obstructive Pulmonary Disease (COPD) Assessed by MRI
- ClinicalTrials.gov ID
- NCT04126616
- Acronym / sponsor ID
- PulmoVasc / 2019-14
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 15 Oct 2025 (actual)
- Study completion
- 15 Oct 2025 (actual)
- First posted
- 15 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 40-70
- Diagnosed with COPD
- Emphysema on chest CT
- FEV1 between 35 and 80 %
- Screened for PH by echocardiography
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| chest Magnetic Resonance Imaging (MRI) using Gadolinium-based contrast agentchest MRI will be performed at rest and after moderate exercise | Diagnostic test | healthy subjects, patients with COPD and PH, patients with COPD without PH |
Primary outcome
Pulmonary blood flow variation from rest to exercise
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
Related trials for Chronic Obstructive Pulmonary Disease (COPD)
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing chest Magnetic Resonance Imaging (MRI) using Gadolinium-based contrast agent in people with Chronic Obstructive Pulmonary Disease (COPD), run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary blood flow variation from rest to exercise (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.