NCT03014609Recruiting
Cardiovascular Risk and Chronic Obstructive Pulmonary Disease
Cardiovascular Risk and Chronic Obstructive Pulmonary Disease (COPD)
Source: ClinicalTrials.gov · Last updated 23 May 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 150 (estimated)
- First submitted
- 4 Jan 2017
- Start date
- 9 Jan 2017
- Primary completion date
- 30 Nov 2029
- Lead sponsor
- University Hospital, Grenoble
- Diseases
- COPD
- NCT number
- NCT03014609
What you commit to
- Study type: Observational
- Planned participants: 150
- From 9 Jan 2017 to the primary completion date, 30 Nov 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients participating in a drug clinical research study
Other illness
- Obvious evolving infection or CRP \> 100 mg/L
Lab values
- Cardiac decompensation considered the main cause of decompensation or chronic heart failure with LVEF \< 45%
Other
- Evolving neoplasia
- On antioxidants: N-acetyl-cysteine, selenium, vit. C, vit. E
- Pregnant or nursing women
- Patients under tutorship or curatorship
- Patients not affiliated to the French social security system (or equivalent)
- Patients deprived of liberty or hospitalized without consent.
Who the study is looking for
- 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
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Grenoble Hospital Coordinator of this site? Confirm its status | Grenoble | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.