Role of Systemic Inflammation in Increase of Cardio-vascular Risk in Chronic Obstructive Pulmonary Disease (BPCO)
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Questionnaires about food habits and tobacco
Spirometry
Carotid echography
Blood sample
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Obstructive Pulmonary Disease focused on measuring systemic inflammation
Eligibility Criteria
Inclusion Criteria:
- Actual or past active smoking of at least 20 packets/year
- FEV1/FVC < 70%
Exclusion Criteria:
- Co-morbidity except essential arterial hypertension controlled by treatment, stable coronary disease, type 2 diabetes and/or degenerative arthropathy (non-inflammatory rheumatic disorder)
- Acute disorder during 8 weeks before inclusion, especially COPD worsening
- Long-term corticosteroid or non-steroid anti-inflammatory treatment
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
COPD
Arm Description
Outcomes
Primary Outcome Measures
Mortality
Secondary Outcome Measures
Full Information
NCT ID
NCT02888886
First Posted
August 31, 2016
Last Updated
August 31, 2016
Sponsor
Central Hospital, Nancy, France
1. Study Identification
Unique Protocol Identification Number
NCT02888886
Brief Title
Role of Systemic Inflammation in Increase of Cardio-vascular Risk in Chronic Obstructive Pulmonary Disease
Acronym
BPCO
Official Title
Role of Systemic Inflammation in Increase of Cardio-vascular Risk in Chronic Obstructive Pulmonary Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Hospital, Nancy, France
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose is to study the correlation between systemic inflammation (serum levels of CRP, IL-1beta, IL-6 and TNF-alpha) or hyperhomocysteinemia and the increase of mortality, in a representative cohort of patients with chronic obstructive pulmonary disease (COPD).
Secondary purposes are:
To confirm the increase of cardiovascular mortality and the importance of cardiovascular morbidity in patients with COPD,
To establish the role of various genetic polymorphisms in the correlation between systemic inflammation and cardiovascular disorders observed in COPD,
To search for acceleration of aging of cardiovascular system evaluated with carotid intima-media thickness when systemic inflammation markers are increased,
To study the correlation between COPD risk factors (tobacco and other food factors), change of respiratory functional data and cardiovascular morbi-mortality. In this study cardiovascular morbi-mortality is defined by following disorders: ischemic cardiopathy, left-sided heart failure, cardiac arrhythmia and cerebrovascular accident. Diagnosis is confirmed with standard techniques and independently of this study. Results of clinical examination, ECG, echocardiography and /or brain scanner will be collected.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
systemic inflammation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
89 (Actual)
8. Arms, Groups, and Interventions
Arm Title
COPD
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Questionnaires about food habits and tobacco
Intervention Type
Other
Intervention Name(s)
Spirometry
Intervention Type
Other
Intervention Name(s)
Carotid echography
Intervention Type
Other
Intervention Name(s)
Blood sample
Intervention Description
for genetic polymorphism analysis, CRP, homocysteine and cytokine tests, glycemia and dyslipidemia analyses
Primary Outcome Measure Information:
Title
Mortality
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Actual or past active smoking of at least 20 packets/year
FEV1/FVC < 70%
Exclusion Criteria:
Co-morbidity except essential arterial hypertension controlled by treatment, stable coronary disease, type 2 diabetes and/or degenerative arthropathy (non-inflammatory rheumatic disorder)
Acute disorder during 8 weeks before inclusion, especially COPD worsening
Long-term corticosteroid or non-steroid anti-inflammatory treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ari CHAOUAT, Pr
Organizational Affiliation
Service des Maladies Respiratoires et Réanimation Respiratoire- Hôpital de Brabois- CHRU de Nancy
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Role of Systemic Inflammation in Increase of Cardio-vascular Risk in Chronic Obstructive Pulmonary Disease
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