To investigate whether patients with hemophilia A develop less coronary artery atherosclerosis as compared to non-hemophilic males.
ID
Source
Brief title
Condition
- Coronary artery disorders
- Blood and lymphatic system disorders congenital
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Coronary artery calcification score (Agatston score).
Secondary outcome
NA.
Background summary
Several cohort studies reported a reduced mortality due to ischemic heart
disease in hemophilia patients as compared to the general population. One
explanation could be that hemophilia patients develop less atherosclerosis than
non-hemophilic males. Although several study groups investigated this
hypothesis, it remains unclear whether the deficiency of factor VIII or IX
exerts a protective effect on the development of atherosclerosis.
Study objective
To investigate whether patients with hemophilia A develop less coronary artery
atherosclerosis as compared to non-hemophilic males.
Study design
In this cross-sectional study, coronary artery calcification, which is a
measure of coronary artery atherosclerosis, will be assessed in hemophilia A
patients with Multi Detector-Row Computed Tomography, a non-invasive vascular
imaging technique. Coronary artery calcification in hemophilia A patients will
be compared with coronary artery calcification in non-hemophilic males.
Study burden and risks
This study will contribute to the knowledge about the role of factor VIII and
the intrinsic coagulation pathway in atherogenesis, can help us understand this
process in further detail, and may eventually lead to new prevention strategies
or medical treatments in patients with hemophilia, and possibly in patients
without hemophilia. However, the results of this study will probably not be
directly beneficial for the participating patients. Participating hemophilia
patients do benefit from their individual cardiovascular risk assessment. If
cardiovascular risk factors are discovered, lifestyle changes will be advised
or medical treatment will be started. Adverse events are not expected to occur
in this study and radiation exposure is very low. One extra visit to the
hospital is needed when participating.
Heidelberglaan 100, Postbus 85500
3508 GA Utrecht
Nederland
Heidelberglaan 100, Postbus 85500
3508 GA Utrecht
Nederland
Listed location countries
Age
Inclusion criteria
•Patients with severe or moderate hemophilia A, >= 59 years
•Non-hemophilic males from the Rotterdam Study, matched for birth year
Exclusion criteria
•Hemophilia patients or non-hemophilic males with symptomatic cardiovascular disease
•Hemophilia patients or non-hemophilic males infected with HIV
•Non-caucasian hemophilia patients or non-hemophilic males
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL26472.041.09 |