Endothelial Function Study Before Cardiovascular Surgery

Terminated

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

• Registration Number: NCT01195064
• Lead Sponsor: University Hospital, Grenoble

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

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-06-01
• Study First Submitted QC: 2010-09-02
• Study First Posted: 2010-09-03
• Primary Completion: 2018-11-30
• Study Completion: 2018-11-30
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-26
• Last Update Posted: 2022-09-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 109

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint is the percent of peripheral arterial tone (PAT) in COPD and/or OSAS patients compared to non COPD non OSAS patients.	one week before their cardiovascular surgery

Secondary Outcome Measures

Name	Time	Method
Polysomnography	one week before their cardiovascular surgery
Evaluation of the systemic inflammation, insulin-resistance and oxidative stress occurring during COPD and/or OSAS patients compared to non COPD non OSAS patients.	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.	one week before their cardiovascular surgery
Functional respiratory exploration	one week before their cardiovascular surgery

Trial Locations

Locations (3)

University Hospital of Angers; 🇫🇷 Angers, France

Mutualist Hospital group; 🇫🇷 Grenoble, France

University Hospital of Grenoble; 🇫🇷 Grenoble, France