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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON55619
Enrollment
50
Registered
2018-08-22
Start date
2018-11-30
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary atherosclerosis

Interventions

None listed

Sponsors

Medisch Universitair Ziekenhuis Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Platelet function as assessed by previously described multi-parameter outcome method (9 surfaces) will consist as the primary endpoint in this proof-of-concept study. Additionally, expression of key platelet receptors will be analyzed via flow cytometry as previously described to build understanding of underlying mechanisms of platelet reactivity.

Secondary

MeasureTime frame
* Platelet count, platelet mean volume (in blood) * Hb, Ht (in blood) * D-Dimer (in plasma) * Experimental/additional biomarkers of thrombogenicity clotting (platelet PF4 in plasma, platelet activation markers by flow cytometry of platelet-rich plasma)

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)