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

NCT02888886 | Completed

• 1 other identifier: 2006-A00053-48
• Study Type: interventional
• Target: 89
• Locations: 0 countries
• Sites: N/A

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

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

systemic inflammation

Outcome Measures

Primary Outcomes (1)

• Mortality

  5 years

Study Arms (1)

COPD

EXPERIMENTAL

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

Interventions

Questionnaires about food habits and tobacco OTHER

COPD

Spirometry OTHER

COPD

Carotid echography OTHER

COPD

Blood sample OTHER

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

COPD

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Co-morbidity except essential arterial hypertension controlled by treatment, stable coronary disease, type 2 diabetes and/or degenerative arthropathy (non-inflammatory rheumatic disorder)
• Long-term corticosteroid or non-steroid anti-inflammatory treatment

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Tobacco Products; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Ari CHAOUAT, Pr

  Service des Maladies Respiratoires et Réanimation Respiratoire- Hôpital de Brabois- CHRU de Nancy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2016
• First Posted: September 5, 2016
• Study Start: July 1, 2007
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: September 5, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share