Protocol Chronic Obstructive Pulmonary Disease

June 3, 2022 updated by: University Hospital, Grenoble

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

121

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Isere
      • Grenoble, Isere, France, 38043
        • France : Laboratoire EFCR - Functional Cardio-Respiratory Exploration Laboratory

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with exacerbated (50) or stable (195) COPD

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Exacerbated COPD patients
Patients with exacerbated COPD
Stable COPD patients
Patients with stable COPD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
peripheral arterial tone
Time Frame: once a year
once a year

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Time Frame
pulse wave velocity measurement
Time Frame: once a year
once a year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 11, 2007

Primary Completion (Actual)

January 21, 2021

Study Completion (Actual)

January 21, 2021

Study Registration Dates

First Submitted

November 27, 2006

First Submitted That Met QC Criteria

November 27, 2006

First Posted (Estimate)

November 28, 2006

Study Record Updates

Last Update Posted (Actual)

June 6, 2022

Last Update Submitted That Met QC Criteria

June 3, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0627

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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