Protocol Chronic Obstructive Pulmonary Disease

Sponsor

University Hospital, Grenoble (Other)

Overall Status

Completed

CT.gov ID

NCT00404430

Collaborator

(none)

121

Enrollment

Location

168.3

Actual Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease Acute Respiratory Failure

Detailed Description

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.

Study Design

Study Type:

Observational

Actual Enrollment :

121 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 11, 2007

Actual Primary Completion Date :

Jan 21, 2021

Actual Study Completion Date :

Jan 21, 2021

Arms and Interventions

Arm	Intervention/Treatment
Exacerbated COPD patients Patients with exacerbated COPD
Stable COPD patients Patients with stable COPD

Outcome Measures

Primary Outcome Measures

peripheral arterial tone [once a year]

Secondary Outcome Measures

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]

Other Outcome Measures

pulse wave velocity measurement [once a year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)