NCT01195064

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2010

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2010

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 3, 2010

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
Last Updated

September 27, 2022

Status Verified

September 1, 2022

Enrollment Period

8.7 years

First QC Date

June 1, 2010

Last Update Submit

September 26, 2022

Conditions

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

Keywords

COPD patientsOSAS patientscardiovascular surgeryEndothelial function

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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 Arms (4)

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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University Hospital of Angers

Angers, 49033, France

Location

Mutualist Hospital group

Grenoble, 38000, France

Location

University Hospital of Grenoble

Grenoble, 38043, France

Location

Related Publications (1)

  • 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.

    PMID: 17765529BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveSleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSleep Apnea SyndromesApneaRespiration DisordersSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Jean-Louis PEPIN, MD, PhD

    University Hospital of Grenoble, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2010

First Posted

September 3, 2010

Study Start

April 1, 2010

Primary Completion

November 30, 2018

Study Completion

November 30, 2018

Last Updated

September 27, 2022

Record last verified: 2022-09

Locations

FR(3)