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Endothelial Function Study Before Cardiovascular Surgery (COPD-OSAS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by University Hospital, Grenoble
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT01195064
First received: June 1, 2010
Last updated: May 29, 2013
Last verified: May 2013

June 1, 2010
May 29, 2013
April 2010
April 2015   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01195064 on ClinicalTrials.gov Archive Site
  • Evaluation of the systemic inflammation, insulin-resistance and oxidative stress occurring during COPD and/or OSAS patients compared to non COPD non OSAS patients. [ Time Frame: one week before their cardiovascular surgery ] [ Designated as safety issue: Yes ]
  • Evaluation of adipose tissue inflammation and oxidative stress occurring during COPD and/or OSAS patients compared to non COPD non OSAS patients. [ Time Frame: one week before their cardiovascular surgery ] [ Designated as safety issue: Yes ]
  • Polysomnography [ Time Frame: one week before their cardiovascular surgery ] [ Designated as safety issue: Yes ]
  • Functional respiratory exploration [ Time Frame: one week before their cardiovascular surgery ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Endothelial Function Study Before Cardiovascular Surgery
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.

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
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Urinary, blood and adipose tissue samples will be collected for measurement of different parameters of inflammation and oxidative stress.

Probability Sample

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.

  • Chronic Obstructive Pulmonary Disease (COPD)
  • Obstructive Sleep Apnea Syndrome (OSAS)
Not Provided
  • 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
Fabbri LM, Rabe KF. From COPD to chronic systemic inflammatory syndrome? Lancet. 2007 Sep 1;370(9589):797-9. No abstract available.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
July 2015
April 2015   (final data collection date for primary outcome measure)

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

Exclusion Criteria:

  • Patient with aortic or mitral valvular replacement
  • Patient with aortic surgery
  • 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
Both
18 Years to 80 Years
No
Contact: Jean-Louis Pépin, MD, PhD 33-476-765-516 JPepin@chu-grenoble.fr
France
 
NCT01195064
RCB 2009-A00916-51, CHU 0921
Yes
University Hospital, Grenoble
University Hospital, Grenoble
Not Provided
Principal Investigator: Jean-Louis PEPIN, MD, PhD University Hospital of Grenoble, France
University Hospital, Grenoble
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP