Endothelial Function Study Before Cardiovascular Surgery (COPD-OSAS)

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 109

Contacts and Locations

Study Locations

• France
  • Angers, France, 49033
    • University Hospital of Angers
  • Grenoble, France, 38043
    • University hospital of Grenoble
  • Grenoble, France, 38000
    • Mutualist Hospital group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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
Polysomnography	one week before their cardiovascular surgery
Functional respiratory exploration	one week before their cardiovascular surgery

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Investigators: Principal Investigator: Jean-Louis Pépin, MD, PhD, University Hospital of Grenoble, France

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): November 30, 2018
• Study Completion (Actual): November 30, 2018

Study Registration Dates

• First Submitted: June 1, 2010
• First Submitted That Met QC Criteria: September 2, 2010
• First Posted (Estimate): September 3, 2010

Study Record Updates

• Last Update Posted (Actual): September 27, 2022
• Last Update Submitted That Met QC Criteria: September 26, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Endothelial function; cardiovascular surgery; COPD patients; OSAS patients
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Lung Diseases; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: RCB 2009-A00916-51, CHU 0921