Protocol Chronic Obstructive Pulmonary Disease

Study Overview
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Brief Summary
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The main objective of the study is to evaluate the predictive factors of the endothelial function to the waning of an acute exacerbation in COPD. It will act to do a multivariate analysis to determine the respective weight of the parameters of the systemic inflammation, of the oxidative stress of the functional respiratory parameters and then functional respiratory parameters. In exacerbated Chronic Obstructive Pulmonary Disease (COPD) patients, there is augmentation of hypoxia and the obstructive ventilatory disorders is more important. This is correlated with an increase in C-reactive Protein (CRP) and of inflammatory cytokines and oxidative stress. It has been demonstrated that there is an endothelial dysfunction in answer to hypoxia. Since the exacerbated COPD patients are hypoxic in most cases , we suppose they have an endothelial dysfunction during exacerbation. So we think we will find an augmentation of vascular resistances ,shown by a peripheral arterial tone too high. And this, certainly, play a part in physiopathology of the COPD exacerbation.

Detailed Description
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We want to judge the improvement of the endothelial function remotely to the acute exacerbation (6 weeks). And then we would like to correlate this improvement with the variations of oxidative stress, muscle strength, respiratory function and systemic inflammation. We also would like to find a relation between the new hospitalizations for respiratory exacerbation and the initial value of endothelial function. Then we would like to evaluate the relationship between the cardiovascular risk and the COPD severity.

Official Title
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Predictive Factors of Endothelial Function in Chronic Obstructive Disease Patients at the End of a Acute Exacerbation.

Conditions
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Chronic Obstructive Pulmonary Disease, Acute Respiratory Failure

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: COPD patients with the waning of exacerbation: Male or Female more than 18 years old VEF1/FCV < 70% or COPD already knew At the moment of the respiratory failure, the day of the enter in hospital: Respiratory frequency >25 PaCO2 > 45 mmHg pH < 7.35 The day of the inclusion in our study: PH > 7.33 at the end of the respiratory failure, or 2 days of continuation, 3 to 7 days post acute exacerbation of continuation Fever < 38.5 Patients who have signed the inform consent form Stable COPD patients: Men or women more than 18 years old VEF1/FCV < 70% or COPD already knew Patients who have signed the inform consent form Exclusion Criteria: Evolutive obvious infection or CRP > 100 at inclusion Cardiac failure considered like the major cause of the exacerbation or cardiac insufficiency with FEVG < 45 % Smoker > 10 cigarettes a day Antioxidant catch: N-acetyl-cystein, selenium, ascorbic acid, alpha tocopherol acetate… Evolutive neoplasia Antioxidant catch: N-acetyl-cystein, selenium, ascorbic acid, alpha tocopherol acetate… pregnant women patient under supervision or trusteeship patient taking part in another clinical trial claustrophobia, patients allergic to contrast agents like Gadolinium, presence of material dissuading the realization of a MRI (pacemaker, implantable defibrillator, insulin pump, ferrometallic clips or foreign bodies in brain or eyes)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Exacerbated COPD patients<br>Patients with exacerbated COPD | |
| Stable COPD patients<br>Patients with stable COPD | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| peripheral arterial tone |  | once a year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle strength measurements |  | once a year | 
| biological markers of inflammation and oxidative stress |  | once a year | 
| respiratory function measurements |  | once a year | 
| Determine the relationship between the RMI measurements and the cardiovascular risk |  | once during the study | 
| Determine the relationship between the hospitalizations for decompensation and the initial value of endothelial function |  | study time frame | 
| Determine the relationship between the RMI measurements and the COPD severity |  | once during the study | 
| Determine the prevalence of nocturnal non-dipping blood pressure in COPD patients |  | once a year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endothelial function, Peripheral Arterial Tone, Systemic Inflammation, Oxidative Stress, Respiratory and peripheral muscular function, Cardiovascular risk, COPD severity