Endothelial Function Study Before Cardiovascular Surgery (COPD-OSAS)

Grenoble Alpes University Hospital Center (CHU)

Status: Terminated

Conditions: Obstructive Sleep Apnea Syndrome (OSAS); Chronic Obstructive Pulmonary Disease (COPD)

Study type: Observational

Funder types: Other

Identifiers

NCT01195064

RCB 2009-A00916-51, CHU 0921

Details and patient eligibility

About

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.

Full 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

Enrollment: 109 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

109 participants in 4 patient groups

COPD+ OSAS- patients

Description:

Patients with chronic obstructive pulmonary disease (COPD) and without obstructive sleep apnea syndrome (OSAS), before planned cardiovascular surgery

COPD- OSAS+ patients

Description:

Patients with obstructive sleep apnea syndrome (OSAS) and without chronic obstructive pulmonary disease (COPD), before planned cardiovascular surgery

COPD+ OSAS+ patients

Description:

Patients with chronic obstructive pulmonary disease (COPD) and with obstructive sleep apnea syndrome (OSAS), with planned cardiovascular surgery

COPD- OSAS- patients

Description:

Patients without chronic obstructive pulmonary disease (COPD) and without obstructive sleep apnea syndrome (OSAS), before planned cardiovascular surgery