Endothelial Function Study Before Cardiovascular Surgery

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

— COPD-OSAS  

Official title:

Endothelial Function Study Before Cardiovascular Surgery in COPD and/or SAS Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01195064
• Other study ID #: RCB 2009-A00916-51, CHU 0921
• Status: Terminated
• Start date: April 2010
• Est. completion date: November 30, 2018

Study information

• Verified date: September 2022
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 physiological study. An interim analysis will be performed when 100 patients will be included.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 109
• Est. completion date: November 30, 2018
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases, Obstructive
• Obstructive Sleep Apnea Syndrome (OSAS)
• Pulmonary Disease, Chronic Obstructive
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
France	University Hospital of Angers	Angers
France	Mutualist Hospital group	Grenoble
France	University Hospital of Grenoble	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (1)

Fabbri LM, Rabe KF. From COPD to chronic systemic inflammatory syndrome? Lancet. 2007 Sep 1;370(9589):797-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Polysomnography		one week before their cardiovascular surgery
Secondary	Functional respiratory exploration		one week before their cardiovascular surgery