The objective of this study is to find out if low plasma PPi levels are involved in PAD. A second aim is find other serum calcification inhibitors involved in PAD.
ID
Source
Brief title
Condition
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Differences in plasma PPi levels in patients with PAD with different Fontaine
stages and healthy controls.
Secondary outcome
Differences in other plasma calcification inhibitors in patients with PAD with
different Fontaine stages and healthy controls.
Background summary
Peripheral arterial disease (PAD) is a chronic vascular disease with an
estimated prevalence of 10% worldwide and up to 30% in patients over 50.
Although always considered a result of atherosclerotic disease of the intimal
arterial wall, recent histopathological studies show that medial arterial
calcification (MAC) is more prevalent than atherosclerosis in femoral arteries
of leg amputees, emphasizing its importance in PAD. Several inhibitors of MAC
have been identified and include among others inorganic pyrophosphate (PPi),
fetuin-a and matrix Gla protein (MGP). Recently, it was shown that the PPi
analogue etidronate can halt progressive MAC in patients with pseudoxanthoma
elasticum (PXE), a calcification disorder due to a deficiency in the PPi
homeostasis. Other treatments targeting for example MGP with vitamin K are
currently under investigation. The aim of this study is to find out if low
plasma PPi levels are involved in PAD. If this is the case, this would rapidly
translate into a clinical trial to test if etidronate can halt arterial
calcification in patients with PAD. A second aim is find other serum
calcification inhibitors involved in PAD. This might give more insight in the
pathophysiology of PAD and might eventually lead to new treatment possibilities
(e.g. vitamin K) and more patient specific treatment approaches.
Study objective
The objective of this study is to find out if low plasma PPi levels are
involved in PAD. A second aim is find other serum calcification inhibitors
involved in PAD.
Study design
Patient control study
Study burden and risks
Plasma of healthy controls is already being collected in the DECIPHER study
(METC 16-622). Blood from 50PAD patients will be collected by venepuncture. The
burden for patients to participate in this study is minimal. A total of 27.5ml
extra blood will be collected along with blood collection for routine medical
care. Participation or refusal to participate in the study will neither have
consequences for their treatment. Aside from the normal risks of these
venepunctures (hematoma formation, tenderness and swelling of the puncture
side, persistent bleeding and vasovagal response) no potential health risks are
assumed.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
1. Age 18 and older.
2. One of four grades of Fontaine classification:
a. Fontaine I: Asymptomatic, incomplete blood vessel obstruction.
b. Fontaine II: Mild claudication pain in limb.
c. Fontaine III: Rest pain, mostly in the feet.
d. Fontaine IV: Necrosis and/or gangrene of the limb.
Exclusion criteria
1. Subjects who are unable or unwilling to sign an informed consent.
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 | NL67567.041.18 |