Primary Objective: a) Do EC/SMC from patients with cardiovascular disease and renal failure have inferior reproductive capacity compared to cells from control donors?Secondary Objectives: a) What is the interindividual variation of cultured…
ID
Source
Brief title
Condition
- Coronary artery disorders
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
During in vitro cell culturing, basic characteristics will be determined and
functional tests in high-throughput assays will be performed. The main endpoint
will be reproductive capacity of each badge of cells.
Secondary outcome
Secondary parameters will be cellular adhesion and thrombogenicity for EC and
extracellular matrix production for SMC. Besides the cellular in vitro assays,
biomarkers for endothelial dysfunction will be measured in plasma. We aim to
measure sICAM, sVCAM, vWF and thrombomodulin. Based on the outcomes of above
mentioned assays, interindidivual variability will be determined by calculating
the coefficient of variation.
Background summary
Vascular tissue engineering (TE) aims to develop a functional small diameter
vascular graft as a replacement of coronary and peripheral arteries or for
vascular access. Based on a biodegradable scaffold, seeded with autologous
cells, these grafts promise better patency then prosthetic materials or even
venous conduits. Within the field of vascular TE, primary endothelial cells
(EC) and smooth muscle cells (SMC) of venous origin are widely used for seeding
tubular constructs before implantation. For succesfull clinical translation it
will be of uttermost importance to define the potentials of patient derived
cells for TE before setting up the animal models and related studies.
Study objective
Primary Objective:
a) Do EC/SMC from patients with cardiovascular disease and renal failure have
inferior reproductive capacity compared to cells from control donors?
Secondary Objectives:
a) What is the interindividual variation of cultured endothelial cells (EC) of
a sick and a control population, regarding cellular reproductive capacity,
adhesion, anti-thrombogenic and immunologic properties?
b) Can in vitro performance (see a.) and thrombogenicity of patient derived EC
be predicted by circulating biomarkers of endothelial dysfunction in peripheral
blood?
c) What is the interindividual variation of cultured SMC of a sick and a
control population, regarding cellular reproductive capacity and matrix
production?
Study design
The potential of patient derived vascular cells will be investigated in a
case-control study, with two different patient groups. Vascular cells from
relatively age/matched control objects without cardiovascular disease will
serve as controls.
Study burden and risks
One blood sample will be drawn by means of venapuncture, and tissue sampling of
rest material will be carried out during regular surgical procedures under
anesthesia. No additional risk is involved with participation in this study. We
have chosen these patient groups because this the target population for future
application of vascular tissue engineering.
Postbus 616
6200MD Maastricht
NL
Postbus 616
6200MD Maastricht
NL
Listed location countries
Age
Inclusion criteria
All groups: Age>18 years
Group A: Patients undergoing elective bypass surgery for coronary arterial disease in which the saphenous vein is used as bypass graft.
Group B: Patients receiving an AV-shunt in which a native arm vein is used for creation of the loop and which are having renal failure. Patients undergoing kidney transplantation.
Group C: Age/sex-matched patients undergoing surgical procedures in which small vessels are usually ligated or removed. Examples of these surgical procedures include thyroidectomy, inguinal hernia repair, or sarcoma resection.
Exclusion criteria
All groups: Age <18 years
Patients who will not provide informed consent.
Group C: History of cardiovascular disease, e.g. hypertension, hypercholesterolemia, diabetes, angina pectoris, myocardial infarction, cerebrovascular accident or peripheral arterial disease and chronic kidney disease. Smoking, or history of smoking in the last 15 years.
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 | NL31333.068.10 |