|- candidate number||22886|
|- NTR Number||NTR5438|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||16-sep-2015|
|- Secondary IDs||NL52159.042.15 ABR nummer|
|- Public Title||MRI vessel wall characteristics of peripheral arteries and arterial stiffness in hemophilia patients |
|- Scientific Title||MRI vessel wall characteristics of peripheral arteries and arterial stiffness in hemophilia patients |
|- hypothesis||The most common cardiovascular risk factor in hemophilia patients is arterial hypertension, which is also more common in this group than in the general population. Since arterial stiffness is an important contributor to arterial hypertension, vascular calcifications of the media and consequently arterial stiffness may be more prevalent in hemophiliacs.
|- Healt Condition(s) or Problem(s) studied||Haemophilia|
|- Inclusion criteria||1. Hemophilia A and B patients|
2. Written informed consent for study participating
3. Males, 18 years and older
4. Documented ABI >0.9
|- Exclusion criteria||1. Patients with symptomatic atherosclerotic disease or history of arterial thrombotic events. |
2. Patients with chronic kidney disease (CKD), defined as eGFR < 60 ml/ min, calculated according to the Modiﬁcation of Diet in Renal Disease formula.
3. Patients with diabetes mellitus, defined as any history of diabetes or current diabetes (diagnosed by HbA1c ¡Ý 6.5% according to the American Diabetes Association diagnostic criteria).
4. Patients with any contraindication to MRI (pacemaker or claustrophobia).
|- mec approval received||no|
|- multicenter trial||no|
|- planned startdate ||1-mrt-2016|
|- planned closingdate||1-mrt-2017|
|- Target number of participants||40|
|- Interventions||Subjects will remain in our study centre for no longer than four hours. MRI scanning will be performed, followed by analysis of pulse wave velocity. Next blood will be drawn and measurement of height, weight will be performed. Patients will be asked to complete a questionnaire about cardiovascular risk factors. |
|- Primary outcome||1. Peripheral artery MRI characteristics (wall thickness, media thickness and stiffness) in hemophilia patients with a normal ankle brachial index and in hemophilia patients with a high ankle brachial index.|
2. Carotid-(right) femoral pulse wave velocity and carotid-(left) radial pulse wave velocity in both groups.
|- Secondary outcome||1. Relation between vessel wall characteristics, arterial stiffness and traditional cardiovascular risk factors. |
2.Relation between vessel wall characteristics, arterial stiffness and severity of haemophilia.
|- Timepoints||single visit|
|- Trial web site||n.a.|
|- CONTACT FOR PUBLIC QUERIES|| Hilde Hop|
|- CONTACT for SCIENTIFIC QUERIES|| Hilde Hop|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG)|
(Source(s) of Monetary or Material Support)
|- Brief summary||Background|
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 and intimal calcifications often coincide and have pathophysiologic processes in common. Clinical consequences differ, but are relevant in both types of calcification Until now, studies on atherosclerosis in patients with hemophilia focused on intimal lesions. There are no reports on medial lesions.
In hemophilia patients arterial hypertension is more common than in de general population. The cause of this increased prevalence is unknown. Medial arterial calcification (MAC) leads to concentric media thickening and stiffening of the arterial wall. Arterial stiffness is an important contributor to arterial hypertension. Therefore, MAC and consequently arterial stiffness may be more prevalent in hemophiliacs, and this may explain the high rate of systolic hypertension.
The objective of the study is to analyze and compare morphological and functional vessel wall parameters of peripheral arteries between hemophilia patients with an ankle- brachial index ≥ 1.3 and hemophilia patients with a normal ankle- brachial index (0.9-1.3)
|- Main changes (audit trail)|
|- RECORD||16-sep-2015 - 18-nov-2015|