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
  Purpose

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.


Condition
Chronic Obstructive Pulmonary Disease (COPD)
Obstructive Sleep Apnea Syndrome (OSAS)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Endothelial Function Study Before Cardiovascular Surgery in COPD and/or SAS Patients

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

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


Estimated Enrollment: 200
Study Start Date: April 2010
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01195064

Contacts
Contact: Jean-Louis Pépin, MD, PhD 33-476-765-516 JPepin@chu-grenoble.fr

Locations
France
University Hospital of Angers Not yet recruiting
Angers, France, 49033
Contact: Frédéric GAGNADOUX, MD, PhD    33 241 353 695    FrGagnadoux@chu-angers.fr   
Sub-Investigator: Frédéric GAGNADOUX, MD, PhD         
Sub-Investigator: Georges LEFTHERIOTIS, MD PhD         
Sub-Investigator: Pascaline PRIOU, MD         
Sub-Investigator: Wojciech TRZEPIZUR, MD         
University Hospital of Grenoble Recruiting
Grenoble, France, 38043
Contact: Jean-Louis PEPIN, MD, PhD    33-476-765-516    JPepin@chu-grenoble.fr   
Principal Investigator: Jean-Louis PEPIN, MD, PhD         
Sub-Investigator: Patrick LEVY, MD, PhD         
Sub-Investigator: Sandrine LAUNOIS-ROLLINAT, MD, PhD         
Sub-Investigator: Renaud TAMISIER, MD, PhD         
Sub-Investigator: Pascal INCAGNOLI, MD         
Sub-Investigator: Pierre ALBALADEJO, MD, PhD         
Sub-Investigator: Guy BARJHOUX, MD         
Sub-Investigator: Damien BEDAGUE, MD         
Sub-Investigator: Bruno CHICHIGNOUD, MD         
Sub-Investigator: Michel DURAND, MD         
Sub-Investigator: Daniel PROTAR, MD         
Sub-Investigator: Delphine RHEM, MD         
Sub-Investigator: Vincent BACH, MD         
Sub-Investigator: Dominique BLIN, MD, PhD         
Sub-Investigator: Olivier CHAVANON, MD, PhD         
Sub-Investigator: Rachid HACINI, MD, PhD         
Sub-Investigator: Jean-Luc MAGNE, MD, PhD         
Sub-Investigator: Carmine SESSA, MD, PhD         
Sub-Investigator: Patrice FAURE, MD, PhD         
Sub-Investigator: Jean-Charles RENVERSEZ, MD, PhD         
Mutualist Hospital group Not yet recruiting
Grenoble, France, 38000
Contact: Amar DEELCHAND, MD    33476707057    a.deelchand@ghm-grenoble.fr   
Sub-Investigator: amar DEELCHAND, MD         
Sub-Investigator: Jean-Yves MEAULLES, MD         
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Principal Investigator: Jean-Louis PEPIN, MD, PhD University Hospital of Grenoble, France
  More Information

Publications:
Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT01195064     History of Changes
Other Study ID Numbers: RCB 2009-A00916-51, CHU 0921
Study First Received: June 1, 2010
Last Updated: May 29, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Grenoble:
COPD patients
OSAS patients
cardiovascular surgery
Endothelial function

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Respiratory Tract Diseases
Apnea
Respiration Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on September 30, 2014