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OpenTrials
Completed

NCT Number: NCT00404430

Protocol Chronic Obstructive Pulmonary Disease

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

France : Laboratoire EFCR - Functional Cardio-Respiratory Exploration Laboratory

Grenoble, Isere, 38043, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. peripheral arterial tone

    Time frame: once a year

Secondary outcomes

  1. Muscle strength measurements

    Time frame: once a year

  2. biological markers of inflammation and oxidative stress

    Time frame: once a year

  3. respiratory function measurements

    Time frame: once a year

  4. Determine the relationship between the RMI measurements and the cardiovascular risk

    Time frame: once during the study

  5. Determine the relationship between the hospitalizations for decompensation and the initial value of endothelial function

    Time frame: study time frame

  6. Determine the relationship between the RMI measurements and the COPD severity

    Time frame: once during the study

  7. Determine the prevalence of nocturnal non-dipping blood pressure in COPD patients

    Time frame: once a year

Other outcomes

  1. pulse wave velocity measurement

    Time frame: once a year

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2021
Study completion
2021
First posted
Nov 28, 2006
Registry last updated
Jun 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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