Does a deep vein thrombosis coincide with changes in HDL protein composition? What are the effects of anticoagulant therapy on HDL protein composition during therapy and after discontinuation of therapy?
ID
Source
Brief title
Condition
- Other condition
- Embolism and thrombosis
Synonym
Health condition
lipiden
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Protein profiling of HDL will be done using SELDI-TOF mass spectrometry.
Additional laboratory testing will include determination of lipid spectrum
(HDL-c, LDL-c, triglycerides, apo A1, apoB, total cholesterol), measurements of
coagulation markers (aPTT, PT, protein S, activated protein C, F1+2, factor
VIII, vWF), markers of fibrinolysis (ddimer) and inflammatory markers (CRP,
Il-6, TNF-a, MCP, Leucocytes, SAA).
Secondary outcome
Additional laboratory testing will include determination of lipid spectrum
(HDL-c, LDL-c, triglycerides, apo A1, apoB, total cholesterol), measurements of
coagulation markers (aPTT, PT, protein S, activated protein C, F1+2, factor
VIII, vWF), markers of fibrinolysis (ddimer) and inflammatory markers (CRP,
Il-6, TNF-a, MCP, Leucocytes, SAA).
Background summary
In spite of significant developments and insights in the pathophysiology of
athero-thrombotic disease, cardiovascular disease is still one of the most
important causes of death in the western world. Medication to lower LDL
cholesterol, one of the major risk factors for atherosclerotic disease, has not
reduced morbidity and mortality due to CVD. Researchers now aim to explore the
influence of other possible determinants of CVD risk, like HDL cholesterol.
Studies show altered protein compositions of HDL particles, against an
inflammatory background, which may eventually lead to a pro-atherogenic state.
Data on an association between arterial and venous disease is accumulating, and
common risk factors have been identified, suggesting common pathways. Limited
data suggests dyslipidemia may be associated with venous thrombo-embolic
disease too. Risk of recurrent DVT has been shown to be associated with both
low HDL levels and low levels of large HDL particles. We aim to analyse the
association between deep vein thrombosis and HDL protein composition.
Study objective
Does a deep vein thrombosis coincide with changes in HDL protein composition?
What are the effects of anticoagulant therapy on HDL protein composition during
therapy and after discontinuation of therapy?
Study design
Patients will be recruited from the Department of Vascular Medicine of the
Academic Medical Centre in Amsterdam. 10 consecutive patients presenting with a
DVT will be included. Serial protein profiling of HDL will be done using
SELDI-TOF mass spectrometry on three different time points (at baseline, 3 to 6
months after initiation of anti-coagulant therapy and one month after
discontinuation of anti-coagulant therapy) and will take place during routine
hospital visits, with the exception of one additional study visit. Patients
(age and sex-matched) with complaints of the leg in whom a DVT has been
excluded will serve as controls and will undergo blood sampling at the same
time points as the cases.
Study burden and risks
Venapuncture will be the only invasive procedure and will be performed on three
occasions. A total of 75 ml of blood will be drawn (25 ml during each visit).
Since the first and second time points will be combined with a routine hospital
visit, only the third hospital visit will be additional. Furthermore during the
second and third visit, fasting blood samples will be taken for the purpose of
this study (not related to routine patient care). Participants will be
compensated for any travelling expenses.
meibergdreef 9
1105 AZ
NL
meibergdreef 9
1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Cases: All patients with a first episode of a (objectified) deep vein thrombosis aged 18 years and older are eligible for participation.
Controls: Age and sex-matched individuals with complaints of the leg, in whom a DVT has been exluded by means of ultrasonography.
Exclusion criteria
Those patienten with a previous venous thrombo-embolism, malignancy or other medical indication requiring long term anticoagulant treatment. Furthermore those patients with a history of cardiovascular disease or those using lipid lowering medication are not eligible for participation.
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 | NL30474.018.09 |