Objective: To compare platelet reactivity and formation of platelet-monocyte complexes between patients with COPD and age-matched controls and to relate this to systemic inflammation.
ID
Source
Brief title
Condition
- Coronary artery disorders
- Bronchial disorders (excl neoplasms)
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Parameters are platelet reactivity (platelet expression of the platelet
activation marker CD62P (P-selectin) and activated fibrinogen receptor (αIIbβ3)
upon stimulation with different platelet agonists), platelet-monocyte
complexes, soluble markers of platelet activation and inflammatory cytokines
and the relation of platelet activation to GOLD classification, exacerbation
rate, smoking and lung function.
Secondary outcome
See primairy outcomes.
Background summary
Rationale: Patients with chronic obstructive pulmonary disease (COPD) are at
increased risk of cardiovascular disease(CVD). Exacerbations increase this risk
further and prevalence of CVD increases with COPD severity. Patients with COPD
have increased baseline levels of systemic inflammation and systemic
inflammation this is thought to play an important role in platelet activation.
Platelet activation leads to platelet aggregation and formation of
platelet-monocyte complexes an early process in thrombosis. So far, no studies
have focused on platelet reactivity, a marker of platelet responsiveness and
functionality, and their relation to inflammatory cytokines in patients with
COPD. We hypothesise that platelet activation in COPD is caused by low grade
systemic inflammation and that platelets are hyper responsive upon stimulation,
a possible risk factor for CVD.
Study objective
Objective: To compare platelet reactivity and formation of platelet-monocyte
complexes between patients with COPD and age-matched controls and to relate
this to systemic inflammation.
Study design
Observational cohort study.
Study burden and risks
Participation in this study involves a maximum of one extra venipuncture during
a regular visit to the outpatient clinic. Blood drawn before a diagnostic
maximum exercise cycle test requires no extra venipuncture. Amount of blood
drawn is 19.5 mL. The burden and risks are minimal and venapuncture is
generally considered safe.
Geert Grooteplein-Zuid 10
Nijmegen 6500HB
NL
Geert Grooteplein-Zuid 10
Nijmegen 6500HB
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study the COPD subjects must meet all of the following criteria:
• >40 years
• Bronchus obstruction detected by spirometry: FEV1/FVC ratio < 70% and postbronchodilatory FEV1<80% (COPD Gold II-IV) and clinical diagnosis confirmed by a pulmonologist.
• >=10 pack years of smoking
Exclusion criteria
• Use of aspirin or other platelet function inhibitors
• Asthma
• Chronic inflammatory diseases, such as rheumatoid arthritis, psoriasis, inflammatory bowel diseases , systemic lupus erythematous (SLE)
• Malignancies
Regarding the control subjects the inclusion criteria described above do not apply, however the exclusion criteria do apply.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL53202.091.15 |