The primary outcome is to assess carotid artery plaque constitution in terms of intraplaque hemorrhage and plaque burden (thickness) as measured with 3T MRI in both hemophilia patients and control patients
ID
Source
Brief title
Condition
- Coagulopathies and bleeding diatheses (excl thrombocytopenic)
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is the plaque constitution in terms of intraplaque
hemorrhage and plaque burden as measured with 3T MRI in both hemophilia
patients and patients and controls
Secondary outcome
Secondary parameters are differences in endothelial wall function and plaque
components (calcification, necrotic core) between the patient and control
group.
Furthermore, the relation between plaque composition and severity of
haemophilia and traditional cardiovascular risk factors will be analysed.
Background summary
Patients with hemophilia have a lifelong increased bleeding tendency due to the
deficiency of factor VIII. We recently showed that hemophilia A patients with
obesity have the same degree of atherosclerosis compared to obese control
subjects. In clinical practice, we indeed see an increasing amount of patients
with stroke and myocardial infarction. There is increasing evidence that
vulnerability of the atherosclerotic plaque greatly increases the risk of
rupture of the plaque, thereby inducing an ischemic event. One of the most
important contributors to the vulnerability of the plaque is intraplaque
hemorrhage.It is unknown whether hemophilia patients are at increased risk of
vulnerable atherosclerotic plaques.
Magnetic resonance imaging (MRI) enables transverse 3-dimensional imaging of
atherosclerosis at high resolution with excellent interscan reproducibility.
3-Tesla MRI visualizes the carotid artery wall and the constitution of the
atherosclerotic plaque. It quantifies plaque volume and is able to assess
bleeding in the plaque. The great advantage of MRI compared to CT-scan is the
fact that MRI carries a low radiation exposure. In addition, it has been shown
that 3T-MRI can also visualise endothelial shear stress, an important marker
for arterial stiffness and remodelling.
Recent magnetic resonance studies have indicated that intraplaque hemorrhage
may accelerate plaque progression and play an important role in plaque
destabilization. An in-vivo study showed that intraplaque hemorrhage also has
considerable impact on plaque stress and strain conditions, which further
increases the risk of rupture.
Study objective
The primary outcome is to assess carotid artery plaque constitution in terms of
intraplaque hemorrhage and plaque burden (thickness) as measured with 3T MRI
in both hemophilia patients and control patients
Study design
Cross-sectional case-control study
Study burden and risks
The study is associated with a low burden. Subjects will remain in our study
centre for no longer than three hours. MRI scanning caries no ionizing
radiation exposure. A MRI constrast agant (Dotarem) will be injected
intravenously. Dotarem has a risk on serious harm. In order to minimize these
risks, patients with kidney failure or a history of allergic reaction to
contrast media will be excluded. Participants might experience some physical
discomfort after administration of Dotarem.
Contrast enhanced MRI- scanning increases the quality of images. The main
components of the plaque can only be distinguished accurately by using
contrast.
Further research is necessary for a better understanding of cardiovascular
disease in haemophilia. Results of this study may lead to new insights on the
pathophysiology of atherosclerosis in haemophilia patients.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
Study population:;1. Hemophilia A or B patients
2. Males, 18 years and older
3. Presence of cardiovascular risk factors, including an age of 50 years and more;Controls:
1. Males, 18 years and older
2.. Presence of cardiovascular risk factors, including an age of 50 years and more
Exclusion criteria
Study population and controls:
1. Symptomatic carotid atherosclerotic disease
2. History of allergic reaction to gadolinium (very rare)
3. History of claustrophobia
4. History of severe renal failure (estimated glomerular filtration rate - < 45 ml/min)
5. Presence of cardiac pacemaker;Controls:
Use of anticoagulation
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL46624.042.13 |
OMON | NL-OMON23229 |