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

Central Hospital, Nancy, France

Status: Completed

Conditions: Chronic Obstructive Pulmonary Disease

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02888886

2006-A00053-48

Details and patient eligibility

About

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.

Enrollment: 89 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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89 participants in 1 patient group

COPD

Experimental group

Treatment:

Other: Blood sample

Other: Questionnaires about food habits and tobacco

Other: Spirometry

Other: Carotid echography