The primary objective will be the prevalence of medial arterial calcification, defined as an ABI * 1.3 and a TBI > 0.7, among hemophiliacs compared with non- hemophiliacs matched by sex and age.
ID
Source
Brief title
Condition
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the ABI in patients with haemophilia as compared to
control subjects.
Secondary outcome
Not applicable
Background summary
Cross- sectional studies recently showed that patients with hemophilia develop
atherosclerosis to the same extent as in the general population, as measured by
intima media thickness of the carotid arteries and coronary calcium score.
Intima calcification is considered to be a characteristic lesion in the
atherosclerotic process. However, calcifications develop at two sites of the
arterial wall: the intima and the media as well.
Medial arterial calcification (MAC), contrary to intima calcification, is a
non-occlusive condition leading to arterial stiffening. MAC occurs in muscle-
type conduit arteries at distal sites of the vascular tree.
Prevalence of MAC is high in patient with diabetes mellitus (DM) and end stage
renal diseases (ESRD). In these pathological conditions MAC is a strong
prognostic marker of cardiovascular mortality. MAC can be detected by
measurement of the ankle brachial index (ABI) . High ABI (* 1.30) is suggestive
for MAC.
We recently analysed the ABI of patients included in the SCARPA study for
atherosclerosis in hemophilia. Unexpectedly, we found an ABI *1.30 in 48.4% of
hemophilia patients (n=69). This could not be explained by known risk factors
as DM or low estimated glomerular filtration rate (eGFR). There is no
literature on high ABI in hemophilia patients. Furthermore high ABI is rare in
the general population (prevalence about 0,5%). Therefore these findings need
further exploration.
First, we want to repeat measurements to confirm our data. To improve
reliability of data toe brachial index (TBI) will be calculated as well in
patients with ABI * 1.3, since digital arteries are usually unaffected by
medial calcification, so in case of MAC ABI is high and TBI should be normal.
Study objective
The primary objective will be the prevalence of medial arterial calcification,
defined as an ABI * 1.3 and a TBI > 0.7, among hemophiliacs compared with non-
hemophiliacs matched by sex and age.
Study design
Cross- sectional single centre study
Study burden and risks
Measurements will take place immediately after a regular doctor visit.
Additional visits to the hospital are not necessary.
Patient are requested to complete a questionnaire on cardiovascular risk
factors. Measurement of ABI and TBI are non- invasive and painless.
Participants may experience some discomfort when blood pressure cuffs are
inflated.
The burden exist of time and sampling of 2 tubes of blood. The participants
will not have immediate benefit from this observational study .
In controls no blood will be drawn. Besides, no TBI will be measured, as no
high ABI is expected in healthy controls.
Hanzeplein 1
Groningen 9713JP
NL
Hanzeplein 1
Groningen 9713JP
NL
Listed location countries
Age
Inclusion criteria
Patients:
Hemophilia A or B
Males, age * 18 years
Written informed consent for study participation;Controls:
Males, age * 18 years
Written informed consent for study participation
Exclusion criteria
Patients:
History of peripheral artery occlusive disease.
Patients with ESRD , defined as eGFR < 60 ml/ min, calculated according to the Modi*cation of Diet in Renal Disease formula.
Patients with diabetes mellitus.;Controls:
History of peripheral artery occlusive disease.
History of renal insufficiency
History of diabetes mellitus
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 | NL51599.042.14 |
| OMON | NL-OMON20634 |