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

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Other: Questionnaires about food habits and tobacco; Other: Spirometry; Other: Carotid echography; Other: Blood sample

• Registration Number: NCT02888886
• Lead Sponsor: Central Hospital, Nancy, France

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:

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2016-08
• Study First Submitted: 2016-08-31
• Study First Submitted QC: 2016-08-31
• Last Update Submitted: 2016-08-31
• Study First Posted: 2016-09-05
• Last Update Posted: 2016-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
COPD	Spirometry	-
COPD	Carotid echography	-
COPD	Blood sample	-
COPD	Questionnaires about food habits and tobacco	-

Primary Outcome Measures

Name	Time	Method
Mortality	5 years