Cardiovascular Risk and Chronic Obstructive Pulmonary Disease
Recruiting · NCT03014609 · Observational (researchers observe without assigning treatment) · Lead sponsor: University Hospital, Grenoble
View the official record on ClinicalTrials.gov →What this trial is about
The principal objective of the study is to measure parameters of inflammation, oxidative stress, and vascular, respiratory, and peripheral muscle function parameters, and identify parameters indicative of evolving cardiovascular risk (CVR) in COPD patients, using multivariate analysis.
Who can take part
Age range
18 Years to 85 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- For patients with stable COPD:
- Men or women aged 18 to 85
- FEV1/FVC \< 70% or proven BPCO
- Patients who have given their free and informed consent in writing
- For patients with decompensated COPD:
- Men or women aged 18 to 85
- FEV1/FVC \< 70% or proven BPCO
- At the time of acute respiratory failure (ARF), when admitted to hospital:
- Respiratory rate \> 25 cycles per minute
- PaCO2 \> 45 mmHg
- blood pH \< 7.35
- When included in the study:
- pH \> 7.33 at the end of ARF, 2 days in a row, or 3 to 7 days post-D1 decompensation (admission to the hospital)
- Fever \< 38.5°C
- Patients who have given their free and informed consent in writing
Exclusion criteria
- Obvious evolving infection or CRP \> 100 mg/L
- Cardiac decompensation considered the main cause of decompensation or chronic heart failure with LVEF \< 45%
- Evolving neoplasia
- On antioxidants: N-acetyl-cysteine, selenium, vit. C, vit. E
- Pregnant or nursing women
- Patients under tutorship or curatorship
- Patients participating in a drug clinical research study
- Patients not affiliated to the French social security system (or equivalent)
- Patients deprived of liberty or hospitalized without consent.
Where it is running
1 location listed.
- University Grenoble Hospital - Grenoble, La Tronche, France