To determine: 1) baseline platelet activation, 2) platelet responses to stimulation with different platelet agonists, 3) formation of platelet-monocyte complexes), 4) effects on plasmatic coagulation, 5) soluble markers of platelet activation and…
ID
Source
Brief title
Condition
- Coronary artery disorders
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1/2) Platelet activation: platelet expression of the platelet activation marker
CD62P (P-selectin) and binding of fibrinogen to the activated fibrinogen
receptor (*IIb*3) at baseline and upon stimulation with different platelet
agonists. 3) Platelet-monocyte complexes. 4) Tissue factor (TF) triggered
thrombin generation. 5) Soluble (plasma) markers of platelet activation and
inflammatory cytokines.
Secondary outcome
Please see the section primary study parameters
Background summary
Chronic obstructive pulmonary disease (COPD) is known for development of severe
cardiovascular co-morbidities. Systemic inflammation is thought to play a role
in development of cardiovascular disease. During acute exacerbations of COPD
(AE-COPD), systemic inflammation increases considerably. Systemic inflammation
drives activation of immune cells, including platelets. Upon activation,
P-selectin is released by platelets and bound to the platelet surface,
enabling formation of platelet-monocyte complexes (PMCs), an early process in
atherothrombosis. Fibrinogen release from platelets effectuates clot formation,
platelet aggregation and adhesion of platelets to the vascular endothelial
surface. In COPD, platelet function in AE-COPD is scarcely studied. This study
aims to address this gap by investigating platelet function and coagulation in
patients with AE-COPD and after convalescence.
Study objective
To determine: 1) baseline platelet activation, 2) platelet responses to
stimulation with different platelet agonists, 3) formation of platelet-monocyte
complexes), 4) effects on plasmatic coagulation, 5) soluble markers of platelet
activation and inflammation, in patients with AE-COPD and after convalescence.
Study design
This study is designed as an exploratory observational cohort study involving
adult patients with an acute exacerbation of COPD by the department of
respiratory diseases in Radboudumc and UCCZ Dekkerswald.
Study burden and risks
Participation in this study involves one venipuncture during an AE-COPD and one
venipuncture during a regular follow-up visit to the outpatient clinic. The
total amount of blood drawn for study purposes is 24mL. The burden is limited
and risks are minimal, as venipuncture is generally considered save.
Geert Grooteplein-Zuid 22
Nijmegen 6525 GA
NL
Geert Grooteplein-Zuid 22
Nijmegen 6525 GA
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
* Spirometry confirmed diagnosis of COPD (i.e. post-bronchodilator FEV1/FVC < Lower limit of normal (LLN)).
* *10 pack years of smoking
Exclusion criteria
* Use of anti-coagulation, aspirin or platelet function inhibitors, with the exception of cyclooxygenase inhibitors (e.g, carbasalate calcium, acetylsalicylic acid)
* Asthma
* Chronic inflammatory diseases, such as rheumatoid arthritis, psoriasis, inflammatory bowel diseases , systemic lupus erythematous (SLE)
* Malignancies
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 | NL59277.091.16 |