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Platelet Activation and Reactivity in Acute Exacerbations of COPD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03017625
Recruitment Status : Unknown
Verified November 2016 by Radboud University.
Recruitment status was:  Not yet recruiting
First Posted : January 11, 2017
Last Update Posted : January 11, 2017
Sponsor:
Information provided by (Responsible Party):
Radboud University

Brief Summary:
Chronic obstructive pulmonary disease (COPD) is known for development of severe cardiovascular co-morbidities. Systemic inflammation during acute exacerbations of COPD (AE-COPD) is thought to play a role in development of cardiovascular disease. Platelets contribute to acute cardiovascular events and atherosclerosis. When platelets are activated, they form complexes with monocytes. These platelet-monocyte complexes (PMCs) are an early process in atherothrombosis and promote inflammation. 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.

Condition or disease Intervention/treatment
COPD Exacerbation Other: Blood is drawn

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Platelet Activation and Responsiveness in Patients With Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AE-COPD)
Study Start Date : January 2017
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : September 2017

Intervention Details:
  • Other: Blood is drawn
    Blood analyses


Primary Outcome Measures :
  1. Platelet activation: platelet expression of CD62P (P-selectin) and fibrinogen binding at baseline and upon ex vivo stimulation. [ Time Frame: Measured at presentation with an AE-COPD and after 8 weeks ]

Secondary Outcome Measures :
  1. Platelet-monocyte interaction (CD14 cells positive for CD61) [ Time Frame: Measured at presentation with an AE-COPD and after 8 weeks ]
  2. Monocyte activation (CD11b expression on CD14 positive cells) [ Time Frame: Measured at presentation with an AE-COPD and after 8 weeks ]
  3. Tissue factor triggered thrombin generation capacity [ Time Frame: Measured at presentation with an AE-COPD and after 8 weeks ]
  4. Plasma markers: Interleukin-6, Interleukin-8, high sensitive-CRP, soluble P-selectin, soluble Fibrinogen, D-dimer [ Time Frame: Measured at presentation with an AE-COPD and after 8 weeks ]

Biospecimen Retention:   Samples Without DNA
Blood, plasma


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with an acute exacerbation of COPD as defined by the Anthonisen criteria
Criteria

Inclusion Criteria:

  • >40 years
  • Spirometry confirmed diagnosis of COPD (i.e. post-bronchodilator FEV1/FVC < 70% and less than 12% on reversibility testing< Lower limit of normal (LLN))
  • ≥10 pack years of smoking

Exclusion Criteria:

  • Use of anti-coagulation or other platelet function inhibitors
  • Asthma
  • Chronic inflammatory diseases, for example rheumatoid arthritis, psoriasis, inflammatory bowel diseases , systemic lupus erythematous (SLE)
  • Malignancies

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03017625


Contacts
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Contact: Floor E Aleva, MD 0031 24 361 03 25 floor.aleva@radboudumc.nl
Contact: Yvonne F Heijdra, MD, PhD 0031 24 361 03 25 yvonne.heijdra@radboudumc.nl

Sponsors and Collaborators
Radboud University
Investigators
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Principal Investigator: Yvonne F Heijdra, Md, PhD Radboud University
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Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT03017625    
Other Study ID Numbers: 2016-2847
First Posted: January 11, 2017    Key Record Dates
Last Update Posted: January 11, 2017
Last Verified: November 2016
Keywords provided by Radboud University:
COPD
Cardiovascular Disease
Platelets
Inflammation