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Exploring the clinical utility of a novel multichannel platelet function test in patients with stable coronary disease

Completed
Conditions
Coronary atherosclerosis
10035534
10011082
10003216
Registration Number
NL-OMON55619
Lead Sponsor
Medisch Universitair Ziekenhuis Maastricht
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
50
Inclusion Criteria

General inclusion criteria:
Able to provide informed consent
Healthy
Age between 18 and 75 years, For the stable ischemic heart disease (SIHD)
population:
Evidence of significant stable coronary artery disease defined by one of the
below mentioned criteria
*Occurrence of a MI more than one year ago. For MI, only type 1 MI (as
described in the third universal definition of MI) will be considered
*Coronary revascularization by either PCI or CABG more than one year ago.
*Evidence of a significant (more than 50%) coronary stenosis on ICA or CCTA.
*Evidence of loss of contractile myocardium consistent with MI on echo, CMR or
CCTA.
*Evidence of myocardial ischemia in two or more myocardial segments on stress
echocardiography or perfusion imaging by SPECT or CMR, 2. Using oral aspirin as
a anti platelet drug, For the healthy control population:
- No additional inclusion criteria. Blood samples will be pre-treated with
aspirin in vitro.
- Treatment with a single dose of oral aspirin (100 mg) as a antiplatelet drug
1 day before blood drawing.

Exclusion Criteria

For the SIHD population:
* Recent (within one year) myocardial infarction or revascularization by either
CABG or PCI.
* Unstable ischemic heart disease (CCS class 4)
* Planned revascularization within one month, For the healthy control
population:
* Subjects currently under any medical care
* Are currently known with any form of atherosclerotic disease
* Are currently taking any antiplatelet drug, except for aspirin

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Platelet function as assessed by previously described multi-parameter outcome<br /><br>method (9 surfaces) will consist as the primary endpoint in this<br /><br>proof-of-concept study. Additionally, expression of key platelet receptors will<br /><br>be analyzed via flow cytometry as previously described to build understanding<br /><br>of underlying mechanisms of platelet reactivity.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>* Platelet count, platelet mean volume (in blood)<br /><br>* Hb, Ht (in blood)<br /><br>* D-Dimer (in plasma)<br /><br>* Experimental/additional biomarkers of thrombogenicity clotting (platelet PF4<br /><br>in plasma, platelet activation markers by flow cytometry of platelet-rich<br /><br>plasma)</p><br>
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