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Hypothesis:
The first part of the study is a survey on the prevalence of anemia of chronic disease (ACD) among COPD patients. The 2nd and 3rd part will test 2 null hypotheses (Ho): 1.serum inflammatory markers and plasma erythropoietin do not differ between COPD patients with and without ACD and 2. exercise capacity does not differ between COPD patients with and without ACD.
Rationale-Aim:
ACD is an immune driven disorder, developing in subjects suffering from chronic inflammatory diseases. COPD is a disorder very likely to be associated to ACD due to its systemic inflammatory dimension. Currently, data on the prevalence of ACD and on the level of inflammatory markers which are implicated in the pathogenesis of ACD in COPD subjects are limited and controversial. Furthermore, there is no data on the effect of ACD on exercise capacity of COPD subjects.
Based to the aforementioned, this study has three goals:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COPD patients with ACD | Other | In the 1st part of this clinical study the prevalence ACD in COPD subjects will be estimated in a consecutive population of COPD subjects who will visit the hospital's pulmonary clinics as outpatients. During the first visit, subjects will give a detailed medical history and will undergo clinical examination and pulmonary function testing 15 minutes post-bronchodilation. Eligible patients will then undergo peripheral venous blood analysis. The first 30 COPD subjects from the population described above, fulfilling the criteria of ACD will constitute the first arm (group of "cases").ACD is defined by low Hb levels (men: <13 mg/dl, women: <12 mg/dl), no other cause of anemia present, normal or increased serum ferritin and decreased total iron binding capacity. |
|
| COPD patients without ACD | Other | Thirty matched patients with COPD without ACD from the initial cohort will constitute the second arm (the "controls") |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| maximal cardiopulmonary exercise testing | Procedure | Cardiopulmonary exercise testing (CPET) will be performed on a cyclic ergometer with continuous monitoring of a 12-lead electrocardiogram, heart rate and blood pressure. While breathing with a mask, the patients will perform a ramp protocol which includes 2-minutes free pedaling and progressive increase of power by 10, 15 or 20 watts/minute; power size will be selected after considering the patient' s daily activity and parameters of pulmonary function. CPET will be performed until exhaustion, unless the subjects reveal symptoms or signs indicating the exercise should stop (e.g. severe breathlessness). |
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome measure is peak oxygen uptake (VO2 peak, ml/kg/min) during maximal cardiopulmonary exercise testing and whether it differs between patients with ACD and COPD and patients with COPD without ACD. | Within 15 days from enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Serum levels of inflammatory markers | Within 15 days from enrollment | |
| Erythropoietin | Within 15 days from enrollment | |
| MRC dyspnea scale |
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Inclusion Criteria:
1st part of the study:
Exclusion Criteria:
1st part of the study:
2nd and 3rd part: As above and additionally:
acute myocardial infarction (in the last 6 months)
unstable angina
left main coronary stenosis or its equivalent
syncope
symptomatic severe aortic stenosis or other moderate stenotic valvular disease
uncontrolled arrhythmias causing symptoms
acute pulmonary embolus or pulmonary infarction
thrombosis of lower extremities
suspected dissecting aneurysm
pulmonary oedema
room air desaturation at rest <85%
severe untreated arterial hypertension at rest (>200 mmHg systolic, >120 mmHg diastolic)
high degree atrioventricular block
hypertrophic cardiomyopathy and
orthopedic impairment that compromises exercise performance
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| Name | Affiliation | Role |
|---|---|---|
| Paraskevi Argyropoulou, MD, Prof | Aristotle University Of Thessaloniki | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Pulmonology, Aristotle University of Thessaloniki | Thessaloniki | 57010 | Greece | |||
| Respiratory Failure Unit, General Hospital "G. Papanikolaou" |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15758012 | Background | Weiss G, Goodnough LT. Anemia of chronic disease. N Engl J Med. 2005 Mar 10;352(10):1011-23. doi: 10.1056/NEJMra041809. No abstract available. | |
| 7582322 | Background | Standards for the diagnosis and care of patients with chronic obstructive pulmonary disease. American Thoracic Society. Am J Respir Crit Care Med. 1995 Nov;152(5 Pt 2):S77-121. No abstract available. |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| peripheral blood samples | Procedure | Peripheral venous blood samples will be collected again in the morning after a fasting period of ≥12 hours. After immediate centrifugation, aliquots will be stored at -75˚C until analysis. Inflammatory markers and erythropoietin will be analyzed by flow cytometry and by enzyme-linked immunosorbent assay, using commercially available kits. |
|
| Within 15 days from enrollment |
| The rest cardiopulmonary exercise testing parameters | Within 15 days from enrollment |
| Thessaloniki |
| 57010 |
| Greece |
| 12524257 | Background | American Thoracic Society; American College of Chest Physicians. ATS/ACCP Statement on cardiopulmonary exercise testing. Am J Respir Crit Care Med. 2003 Jan 15;167(2):211-77. doi: 10.1164/rccm.167.2.211. No abstract available. |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |