N/A
N=82
Arterial Function and Atherosclerosis in Essential Thrombocythemia
Atherosclerosis
Bottom Line
View on ClinicalTrials.gov: NCT03828422 ↗Enrolled (actual)
82
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcome: Primary: Carotid Artery Stiffness (Expressed by Beta-stiffness Index ) in JAK2 V617F Positive ET Patients in Comparison to Healthy Control Subjects in a 4-year Period (From Baseline to Year 4). — 1.95; 0.22 index
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- imaging (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University Medical Centre Ljubljana
- Primary completion
- Aug 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Carotid Artery Stiffness (Expressed by Beta-stiffness Index ) in JAK2 V617F Positive ET Patients in Comparison to Healthy Control Subjects in a 4-year Period (From Baseline to Year 4). |
1.95; 0.22 | — |
| PRIMARY Carotid Artery Stiffness (Expressed by the Pulse Wave Velocity) in JAK2 V617F Positive ET Patients in Comparison to Healthy Control Subjects in a 4-year Period (From Baseline to Year 4). |
0.72; 0.08 | — |
| PRIMARY Change of Carotid Artery Plaque Score in JAK2 V617F Positive ET Patients in Comparison to Healthy Control Subjects in a 4-year Period. |
0; 0 | — |
| PRIMARY Change of Coronary Calcium Burden in JAK2 V617F Positive ET Patients in Comparison to Healthy Control Subjects in a 4-year Period. |
0; 1.6 | — |
| PRIMARY Change of Digital Endothelial Function, Expressed as Reactive Hyperemia Index and Augmentation Index (AI), in JAK2 V617F Positive ET Patients in Comparison to Healthy Control Subjects in a 4-year Period. |
-0.02; -0.26; 3.56; 0.46 | — |
| PRIMARY The JAK2 V617F Mutation Burden in Patients With JAK2 V617F Positive ET. |
29.95; 11.60 | — |
Summary
The aim of the study is to examine (a) whether patients with JAK2 V617F positive ET in comparison to age-and sex-matched, apparently healthy control subjects show more advanced progression of arterial stiffness, pulse-wave velocity and coronary calcium score in a 4 year observation period, and (b) whether the burden of JAK2 V617F mutation correlates with the measured vascular parameters. All subjects will be examined twice. The first visit already took place between the years 2014 - 2015 and the second visit will take place between 2018-2019. All participants will have signed their informed consent before entering the study. Each visit will consist of completing a structured questionnaire (on personal and family medical history, risk factors for CVD and medication), physical examination, donating a blood sample for laboratory tests and undergoing carotid ultrasound and coronary calcium measurement oft the extent of coronary artery calcification. At the first and the second examination the JAK2 V617F allele burden, i.e. the percentage of mutated alleles, will be determined from genomic DNA in peripheral blood.
Eligibility Criteria
Inclusion Criteria
- patients with JAK2 V617F positive essential thrombocythemia
- age-and sex-matched apparently healthy control subjects
Exclusion Criteria
- personal history of any atherosclerotic vascular disease (myocardial infarction, angina pectoris, peripheral arterial disease, aortic disease, transient ischemic attack or ischemic stroke)
- chronic kidney disease stage 3 and above
- known cancer
- chronic inflammatory disease
- autoimmune disease
- pregnancy
Data sourced from ClinicalTrials.gov (NCT03828422). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.