Endothelial Function Study Before Cardiovascular Surgery

NCT ID: NCT01195064

Last Updated: 2022-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

109 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-04-30

Study Completion Date

2018-11-30

Brief Summary

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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

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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

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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COPD+ OSAS- patients

Patients with chronic obstructive pulmonary disease (COPD) and without obstructive sleep apnea syndrome (OSAS), before planned cardiovascular surgery

No interventions assigned to this group

COPD- OSAS+ patients

Patients with obstructive sleep apnea syndrome (OSAS) and without chronic obstructive pulmonary disease (COPD), before planned cardiovascular surgery

No interventions assigned to this group

COPD+ OSAS+ patients

Patients with chronic obstructive pulmonary disease (COPD) and with obstructive sleep apnea syndrome (OSAS), with planned cardiovascular surgery

No interventions assigned to this group

COPD- OSAS- patients

Patients without chronic obstructive pulmonary disease (COPD) and without obstructive sleep apnea syndrome (OSAS), before planned cardiovascular surgery

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Louis PEPIN, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Grenoble, France

Locations

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University Hospital of Angers

Angers, , France

Site Status

Mutualist Hospital group

Grenoble, , France

Site Status

University Hospital of Grenoble

Grenoble, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 17765529 (View on PubMed)

Other Identifiers

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RCB 2009-A00916-51, CHU 0921

Identifier Type: -

Identifier Source: org_study_id

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