COPD ExacerbationNCT03017625
Platelet Activation and Reactivity in Acute Exacerbations of COPD
An observational study of COPD Exacerbation, run by Radboud University Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 99 years
- Conditions the study is for
- COPD Exacerbation
- What is being tested?
- Blood is drawn
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with an acute exacerbation of COPD as defined by the Anthonisen criteria
Who may be able to join
- >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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Platelet Activation and Responsiveness in Patients With Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AE-COPD)
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
- Being tested
- Blood is drawn
- Keywords
- COPD, Cardiovascular Disease, Platelets, Inflammation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Cardiovascular Diseases, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood is drawnOther
Blood analyses
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet activation: platelet expression of CD62P (P-selectin) and fibrinogen binding at baseline and upon ex vivo stimulation.
Measured: Measured at presentation with an AE-COPD and after 8 weeks
Secondary outcomes (4)
Platelet-monocyte interaction (CD14 cells positive for CD61)
Measured: Measured at presentation with an AE-COPD and after 8 weeks
Monocyte activation (CD11b expression on CD14 positive cells)
Measured: Measured at presentation with an AE-COPD and after 8 weeks
Tissue factor triggered thrombin generation capacity
Measured: 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: Measured at presentation with an AE-COPD and after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionJun 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD ExacerbationStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yvonne F Heijdra, Md, PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03017625
- Sponsor's protocol ID
- 2016-2847
- Status last verified
- Nov 2016
- First submitted
- 12 Dec 2016
- Last updated
- 11 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Activation and Responsiveness in Patients With Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AE-COPD)
- ClinicalTrials.gov ID
- NCT03017625
- Acronym / sponsor ID
- 2016-2847
- Conditions
- COPD Exacerbation
- Keywords
- COPD, Cardiovascular Disease, Platelets, Inflammation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 11 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with an acute exacerbation of COPD as defined by the Anthonisen criteria
Key inclusion criteria (3 listed)
- >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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood is drawnBlood analyses | Other | – |
Primary outcome
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
4 secondary outcomes
Platelet-monocyte interaction (CD14 cells positive for CD61)
Time frame: Measured at presentation with an AE-COPD and after 8 weeks
Monocyte activation (CD11b expression on CD14 positive cells)
Time frame: Measured at presentation with an AE-COPD and after 8 weeks
Tissue factor triggered thrombin generation capacity
Time frame: 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
Time frame: Measured at presentation with an AE-COPD and after 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yvonne F Heijdra, Md, PhD principal investigator
Radboud University Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of COPD Exacerbation, run by Radboud University Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Floor E Aleva, MD (0031 24 361 03 25, floor.aleva@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2017.