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Clinical Trials/NCT01195064
NCT01195064
Terminated
Not Applicable

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

University Hospital, Grenoble3 sites in 1 country109 target enrollmentApril 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Obstructive Pulmonary Disease (COPD)
Sponsor
University Hospital, Grenoble
Enrollment
109
Locations
3
Primary Endpoint
The primary endpoint is the percent of peripheral arterial tone (PAT) in COPD and/or OSAS patients compared to non COPD non OSAS patients.
Status
Terminated
Last Updated
3 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
April 2010
End Date
November 30, 2018
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Grenoble
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

The primary endpoint is the percent of peripheral arterial tone (PAT) in COPD and/or OSAS patients compared to non COPD non OSAS patients.

Time Frame: one week before their cardiovascular surgery

Secondary Outcomes

  • 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)

Study Sites (3)

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