Chronic Obstructive Pulmonary Disease (COPD)COPD-OSASNCT01195064
Endothelial Function Study Before Cardiovascular Surgery
An observational study of Chronic Obstructive Pulmonary Disease (COPD) and Obstructive Sleep Apnea Syndrome (OSAS), run by University Hospital, Grenoble at 3 sites in France.
Trial summary
The aim of this clinical trial is to evaluate the effect of chronic obstructive pulmonary disease (COPD) and/or obstructive sleep apnea syndrome (OSAS) on the endothelial function, before cardiovascular surgery, compared to non COPD non OSAS patients undergoing also a cardiovascular surgery, by an observational… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD), Obstructive Sleep Apnea Syndrome (OSAS)
- How many people
- 109 participants
- Where
- 3 sitesFrance
- Study dates
- Apr 2010to 30 Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting with chronic obstructive pulmonary disease (COPD) and/or obstructive sleep apnea syndrome (OSAS) or control patients without these pathologies, before planned cardiovascular surgery.
Who may be able to join
- Men or women between 18 and 80 years old
- Patient with planned coronary artery bypass graft surgery
- Patient with planned peripheral vascular surgery
- Patient with aortic surgery
Who cannot join
- Patient with aortic or mitral valvular replacement
- Patient with emergency peripheral valvular surgery
- Patient with emergency coronary artery bypass graft surgery
- Patient with evolutive malignancy disease
- Pregnant or lactating women
- Patient with inadvisable bronchodilator (used for functional respiratory) exploration
Trial locations and contacts
3 sites in 1 country.
France3 sites
University Hospital of Angers
Angers, 49033
Mutualist Hospital group
Grenoble, 38000
University Hospital of Grenoble
Grenoble, 38043
About this study
Official title: Endothelial Function Study Before Cardiovascular Surgery in COPD and/or SAS Patients
The aim of this clinical trial is to evaluate the effect of chronic obstructive pulmonary disease (COPD) and/or obstructive sleep apnea syndrome (OSAS) on the endothelial function, before cardiovascular surgery, compared to non COPD non OSAS patients undergoing also a cardiovascular surgery, by an observational physiological study.
An interim analysis will be performed when 100 patients will be included.
Read the detailed description
Secondary objectives of this clinical trial :
- To evaluate the effect of COPD and/or OSAS on the systemic inflammation, insulin-resistance and oxydative stress, in comparison with non COPD non OSAS patients.
- To evaluate the effect of COPD and/or OSAS on the inflammation and oxydative stress of the adipose tissue, in comparison with non COPD non OSAS patients.
- To validate the STOP-BANG questionnaire in patients undergoing a cardiovascular surgery
- Keywords
- COPD patients, OSAS patients, cardiovascular surgery, Endothelial function
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| COPD+ OSAS- patients | Patients with chronic obstructive pulmonary disease (COPD) and without obstructive sleep apnea syndrome (OSAS), before planned cardiovascular surgery | |
| COPD- OSAS+ patients | Patients with obstructive sleep apnea syndrome (OSAS) and without chronic obstructive pulmonary disease (COPD), before planned cardiovascular surgery | |
| COPD+ OSAS+ patients | Patients with chronic obstructive pulmonary disease (COPD) and with obstructive sleep apnea syndrome (OSAS), with planned cardiovascular surgery | |
| COPD- OSAS- patients | Patients without chronic obstructive pulmonary disease (COPD) and without obstructive sleep apnea syndrome (OSAS), before planned cardiovascular surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the percent of peripheral arterial tone (PAT) in COPD and/or OSAS patients compared to non COPD non OSAS patients.
Measured: one week before their cardiovascular surgery
Secondary outcomes (4)
Evaluation of the systemic inflammation, insulin-resistance and oxidative stress occurring during COPD and/or OSAS patients compared to non COPD non OSAS patients.
Measured: one week before their cardiovascular surgery
Evaluation of adipose tissue inflammation and oxidative stress occurring during COPD and/or OSAS patients compared to non COPD non OSAS patients.
Measured: one week before their cardiovascular surgery
Polysomnography
Measured: one week before their cardiovascular surgery
Functional respiratory exploration
Measured: one week before their cardiovascular surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2010 (estimated)
- Study startApr 2010
- Primary completion30 Nov 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Louis PEPIN, MD, PhD, Principal investigator, University Hospital of Grenoble, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01195064
- Sponsor's protocol ID
- RCB 2009-A00916-51, CHU 0921
- Acronym
- COPD-OSAS
- Status last verified
- Sep 2022
- First submitted
- 1 Jun 2010
- Last updated
- 27 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fabbri LM, Rabe KF. From COPD to chronic systemic inflammatory syndrome? Lancet. 2007 Sep 1;370(9589):797-9. doi: 10.1016/S0140-6736(07)61383-X. No abstract available.
PubMed 17765529
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endothelial Function Study Before Cardiovascular Surgery in COPD and/or SAS Patients
- ClinicalTrials.gov ID
- NCT01195064
- Acronym / sponsor ID
- COPD-OSAS / RCB 2009-A00916-51, CHU 0921
- Keywords
- COPD patients, OSAS patients, cardiovascular surgery, Endothelial function
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 109 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 3 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this clinical trial is to evaluate the effect of chronic obstructive pulmonary disease (COPD) and/or obstructive sleep apnea syndrome (OSAS) on the endothelial function, before cardiovascular surgery, compared to non COPD non OSAS patients undergoing also a cardiovascular surgery, by an observational physiological study.
An interim analysis will be performed when 100 patients will be included.
Detailed description
Secondary objectives of this clinical trial :
- To evaluate the effect of COPD and/or OSAS on the systemic inflammation, insulin-resistance and oxydative stress, in comparison with non COPD non OSAS patients.
- To evaluate the effect of COPD and/or OSAS on the inflammation and oxydative stress of the adipose tissue, in comparison with non COPD non OSAS patients.
- To validate the STOP-BANG questionnaire in patients undergoing a cardiovascular surgery
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| COPD+ OSAS- patients | – | –Patients with chronic obstructive pulmonary disease (COPD) and without obstructive sleep apnea syndrome (OSAS), before planned cardiovascular surgery |
| COPD- OSAS+ patients | – | –Patients with obstructive sleep apnea syndrome (OSAS) and without chronic obstructive pulmonary disease (COPD), before planned cardiovascular surgery |
| COPD+ OSAS+ patients | – | –Patients with chronic obstructive pulmonary disease (COPD) and with obstructive sleep apnea syndrome (OSAS), with planned cardiovascular surgery |
| COPD- OSAS- patients | – | –Patients without chronic obstructive pulmonary disease (COPD) and without obstructive sleep apnea syndrome (OSAS), before planned cardiovascular surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting with chronic obstructive pulmonary disease (COPD) and/or obstructive sleep apnea syndrome (OSAS) or control patients without these pathologies, before planned cardiovascular surgery.
Key inclusion criteria (4 listed)
- Men or women between 18 and 80 years old
- Patient with planned coronary artery bypass graft surgery
- Patient with planned peripheral vascular surgery
- Patient with aortic surgery
Key exclusion criteria (6 listed)
- Patient with aortic or mitral valvular replacement
- Patient with emergency peripheral valvular surgery
- Patient with emergency coronary artery bypass graft surgery
- Patient with evolutive malignancy disease
- Pregnant or lactating women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary endpoint is the percent of peripheral arterial tone (PAT) in COPD and/or OSAS patients compared to non COPD non OSAS patients.
Time frame: one week before their cardiovascular surgery
4 secondary outcomes
Evaluation of the systemic inflammation, insulin-resistance and oxidative stress occurring during COPD and/or OSAS patients compared to non COPD non OSAS patients.
Time frame: one week before their cardiovascular surgery
Evaluation of adipose tissue inflammation and oxidative stress occurring during COPD and/or OSAS patients compared to non COPD non OSAS patients.
Time frame: one week before their cardiovascular surgery
Polysomnography
Time frame: one week before their cardiovascular surgery
Functional respiratory exploration
Time frame: one week before their cardiovascular surgery
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2022.
- Background: PubMed 17765529Fabbri LM, Rabe KF. From COPD to chronic systemic inflammatory syndrome? Lancet. 2007 Sep 1;370(9589):797-9. doi: 10.1016/S0140-6736(07)61383-X. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Louis PEPIN, MD, PhD principal investigator
University Hospital of Grenoble, France
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease (COPD) and Obstructive Sleep Apnea Syndrome (OSAS), run by University Hospital, Grenoble at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint is the percent of peripheral arterial tone (PAT) in COPD and/or OSAS patients compared to non COPD non OSAS patients. (time frame: one week before their cardiovascular surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01195064, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2022.