Platelet Activation and Reactivity in Acute Exacerbations of COPD

NCT03017625 | Unknown DMC

• 1 other identifier: 2016-2847
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

COPD Exacerbation

Keywords

COPD; Cardiovascular Disease; Platelets; Inflammation

Outcome Measures

Primary Outcomes (1)

• Platelet activation: platelet expression of CD62P (P-selectin) and fibrinogen binding at baseline and upon ex vivo stimulation.

  Measured at presentation with an AE-COPD and after 8 weeks

Secondary Outcomes (4)

• Platelet-monocyte interaction (CD14 cells positive for CD61)

  Measured at presentation with an AE-COPD and after 8 weeks

• Monocyte activation (CD11b expression on CD14 positive cells)

  Measured at presentation with an AE-COPD and after 8 weeks

• Tissue factor triggered thrombin generation capacity

  Measured at presentation with an AE-COPD and after 8 weeks

• Plasma markers: Interleukin-6, Interleukin-8, high sensitive-CRP, soluble P-selectin, soluble Fibrinogen, D-dimer

  Measured at presentation with an AE-COPD and after 8 weeks

Interventions

Blood is drawn OTHER

Blood analyses

Eligibility Criteria

• Age: 40 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with an acute exacerbation of COPD as defined by the Anthonisen criteria

You may qualify if:

• \>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

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood, plasma

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Cardiovascular Diseases; Inflammation

Condition Hierarchy (Ancestors)

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

Study Officials

• Yvonne F Heijdra, Md, PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Floor E Aleva, MD

CONTACT

0031 24 361 03 25; floor.aleva@radboudumc.nl

Yvonne F Heijdra, MD, PhD

CONTACT

0031 24 361 03 25; yvonne.heijdra@radboudumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2016
• First Posted: January 11, 2017
• Study Start: January 1, 2017
• Primary Completion: June 1, 2017
• Study Completion: September 1, 2017
• Last Updated: January 11, 2017

Record last verified: 2016-11