Clinical trial NCT01195064: Endothelial Function Study Before Cardiovascular Surgery
Official title: Endothelial Function Study Before Cardiovascular Surgery in COPD and/or SAS Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Obstructive Sleep Apnea Syndrome (OSAS)
Keywords: COPD patients
OSAS patients
cardiovascular surgery
Endothelial function
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2010-09-03
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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 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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
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.
timeFrame: one week before their cardiovascular surgery
Secondary outcomes:
measure: Evaluation of the systemic inflammation, insulin-resistance and oxidative stress occurring during COPD and/or OSAS patients compared to non COPD non OSAS patients.
timeFrame: one week before their cardiovascular surgery
measure: Evaluation of adipose tissue inflammation and oxidative stress occurring during COPD and/or OSAS patients compared to non COPD non OSAS patients.
timeFrame: one week before their cardiovascular surgery
measure: Polysomnography
timeFrame: one week before their cardiovascular surgery
measure: Functional respiratory exploration
timeFrame: one week before their cardiovascular surgery
Other outcomes:
Locations:
city: Angers
country: France
facility: University Hospital of Angers
city: Grenoble
country: France
facility: Mutualist Hospital group
city: Grenoble
country: France
facility: University Hospital of Grenoble
Study officials:
affiliation: University Hospital of Grenoble, France
name: Jean-Louis PEPIN, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.