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Protocol Chronic Obstructive Pulmonary Disease

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00404430
Enrollment
121
Registered
2006-11-28
Start date
2007-01-11
Completion date
2021-01-21
Last updated
2022-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Failure, Chronic Obstructive Pulmonary Disease

Keywords

Endothelial function, Peripheral Arterial Tone, Systemic Inflammation, Oxidative Stress, Respiratory and peripheral muscular function, Cardiovascular risk, COPD severity

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.

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.

Interventions

None listed

Sponsors

University Hospital, Grenoble
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
peripheral arterial toneonce a year

Secondary

MeasureTime frame
Muscle strength measurementsonce a year
biological markers of inflammation and oxidative stressonce a year
respiratory function measurementsonce a year
Determine the relationship between the hospitalizations for decompensation and the initial value of endothelial functionstudy time frame
Determine the relationship between the RMI measurements and the COPD severityonce during the study
Determine the prevalence of nocturnal non-dipping blood pressure in COPD patientsonce a year
Determine the relationship between the RMI measurements and the cardiovascular riskonce during the study

Other

MeasureTime frame
pulse wave velocity measurementonce a year

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026