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CompletedNCT02888886BPCOUpdated Sep 5, 2016

Role of Systemic Inflammation in Increase of Cardio-vascular Risk in Chronic Obstructive Pulmonary Disease

An interventional study of Questionnaires about food habits and tobacco and Spirometry in Chronic Obstructive Pulmonary Disease, sponsored by Central Hospital, Nancy, France. Completed. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-09-05.

Sponsored by Central Hospital, Nancy, France · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
89
Allocation
Not applicable
Ages
40 Years to 75 Years
Sex
All
01

Study 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:

  1. To confirm the increase of cardiovascular mortality and the importance of cardiovascular morbidity in patients with COPD,
  2. To establish the role of various genetic polymorphisms in the correlation between systemic inflammation and cardiovascular disorders observed in COPD,
  3. To search for acceleration of aging of cardiovascular system evaluated with carotid intima-media thickness when systemic inflammation markers are increased,
  4. 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.
02

Conditions studied

  • Chronic Obstructive Pulmonary Disease

Keywords

  • systemic inflammation
03

In context

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's enrollment of 89 is above the median of 72 across 2,118 interventional studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

Central Hospital, Nancy, France is the lead sponsor of 778 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Actual or past active smoking of at least 20 packets/year
  • FEV1/FVC \< 70%

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
89 participants (actual)

Study arms

  • Experimental
    COPD

    Other: Questionnaires about food habits and tobacco · Other: Spirometry · Other: Carotid echography · Other: Blood sample

Interventions

  • OtherQuestionnaires about food habits and tobacco
  • OtherSpirometry
  • OtherCarotid echography
  • OtherBlood sample

    for genetic polymorphism analysis, CRP, homocysteine and cytokine tests, glycemia and dyslipidemia analyses

06

What researchers measure

Primary outcomes

  1. Mortality

    Time frame: 5 years

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 5, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02888886
Lead sponsor
Central Hospital, Nancy, France
Responsible party
Sponsor
First posted
Sep 5, 2016
Start date
Jul 2007
Primary completion
Nov 2015
Completion
Nov 2015
Last update
Sep 5, 2016

Study contacts

Ari CHAOUAT, Pr
principal investigator · Service des Maladies Respiratoires et Réanimation Respiratoire- Hôpital de Brabois- CHRU de Nancy

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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