Protocol Chronic Obstructive Pulmonary Disease
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| ClinicalTrials.gov Identifier: NCT00404430 |
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Recruitment Status :
Active, not recruiting
First Posted : November 28, 2006
Last Update Posted : January 18, 2020
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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.
| Condition or disease |
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| Chronic Obstructive Pulmonary Disease Acute Respiratory Failure |
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 |
| 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. |
| Study Start Date : | January 2007 |
| Estimated Primary Completion Date : | February 2021 |
| Estimated Study Completion Date : | February 2021 |
| Group/Cohort |
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Exacerbated COPD patients
Patients with exacerbated COPD
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Stable COPD patients
Patients with stable COPD
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- peripheral arterial tone [ Time Frame: once a year ]
- Muscle strength measurements [ Time Frame: once a year ]
- biological markers of inflammation and oxidative stress [ Time Frame: once a year ]
- respiratory function measurements [ Time Frame: once a year ]
- Determine the relationship between the RMI measurements and the cardiovascular risk [ Time Frame: once during the study ]
- Determine the relationship between the hospitalizations for decompensation and the initial value of endothelial function [ Time Frame: study time frame ]
- Determine the relationship between the RMI measurements and the COPD severity [ Time Frame: once during the study ]
- Determine the prevalence of nocturnal non-dipping blood pressure in COPD patients [ Time Frame: once a year ]
- pulse wave velocity measurement [ Time Frame: once a year ]
Biospecimen Retention: Samples With DNA
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00404430
| France | |
| France : Laboratoire EFCR - Functional Cardio-Respiratory Exploration Laboratory | |
| Grenoble, Isere, France, 38043 | |
| Principal Investigator: | Jean-Louis JP Pépin, ProfessorPhD | University Hospital, Grenoble |
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University Hospital, Grenoble |
| ClinicalTrials.gov Identifier: | NCT00404430 |
| Other Study ID Numbers: |
0627 |
| First Posted: | November 28, 2006 Key Record Dates |
| Last Update Posted: | January 18, 2020 |
| Last Verified: | January 2020 |
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Endothelial function Peripheral Arterial Tone Systemic Inflammation Oxidative Stress |
Respiratory and peripheral muscular function Cardiovascular risk COPD severity |
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Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive |
Respiratory Insufficiency Respiratory Tract Diseases Respiration Disorders |