Our primary objectives are to evaluate - if endogenous EPO, EPC levels and EPC function are different in patients with stable and unstable CAD, compared to age and sex matched controls;- if a correlation exists between endogenous EPO and EPC levels…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To assess the correlation between endogenous EPO levels and coronary collateral
flow
Secondary outcome
The secundary objectives are:
- to assess if there are differences in endogenous EPO leves, EPC levels and
EPC function in patients with stable and unstable CAD, compared to age and sex
matched controls;
- to explore the correlation between the number of functional EPCs and the
extent of coronary collateral flow in patients with stable and unstable angina;
- to study the effect of resolving the coronary artery stenosis on endogenous
EPO and EPC levels/function before and after the PCI procedure.
Background summary
Erythropoietin (EPO) is known to maintain a constant plasma haemoglobin (Hb)
level. The main mechanism by which EPO stimulates red blood cell formation is
by prevention of apoptosis of erythroid progenitor cells. Recently it has
become known that EPO and its receptor are also present in other tissues like
brain and myocardial tissue. Here, EPO also has an anti-apoptotic effect.
Another interesting effect of EPO is the stimulation of endothelial progenitor
cells (EPC)s and the subsequent growth of new vessels on existing vessels
(angiogenesis). In patients with ischemia, both EPO and EPC levels are raised.
These elevated levels might have a protective function for the ischemic
myocardial tissue, not only by protecting myocardial cells from apoptosis, but
also by promoting coronary collateral formation. Eventually, both mechanisms
will help to maintain the heart*s pumping function. To gain further insights
into these mechanisms, we want to explore the relationship between EPO, EPCs
and collateral growth. Therefore, we hypothesise that EPO and EPC levels are
elevated in ischemic heart conditions and that a relationship exists between
these levels and coronary collateral flow.
Study objective
Our primary objectives are to evaluate
- if endogenous EPO, EPC levels and EPC function are different in patients with
stable and unstable CAD, compared to age and sex matched controls;
- if a correlation exists between endogenous EPO and EPC levels and coronary
collateral flow in patients with both stable and unstable coronary artery
disease;
- the correlation between the number of functional EPCs and the extent of
coronary collateral flow in patients with stable and unstable angina;
- the effect of resolving the coronary artery stenosis on endogenous EPO and
EPC levels/function before and after the PCI procedure.
Study design
This is a prospective, observational cohort study.
Study burden and risks
A standard PCI procedure will be executed by well-trained physicians and all
patients will receive standard medical care. After the start of the procedure,
baseline blood samples will be obtained from the introductory sheath. From 10
patients in each group, this baseline measurement will be performed by drawing
blood simultaneously from the coronary sinus and from the aorta ascendens, to
be able to measure the myocardial production of EPO and EPC*s. For this
measurement, an additional right heart catheterisation is needed. Furthermore,
in all patients, the fractional flow reserve (FFR) will be determined by
injection of adenosine in the occluded coronary vessel to determine the extent
of the occlusion. After the PCI procedure, the collateral flow index (CFI) will
be determined for measurement of coronary collateral flow. Venous blood samples
will be collected at 4 hours, 24 hours or at discharge and at 6 weeks.
From the 10 control patients, blood samples will be collected at a single
timepoint.
hanzeplein 1
9700RB groningen
Nederland
hanzeplein 1
9700RB groningen
Nederland
Listed location countries
Age
Inclusion criteria
Group A
• Men and women > 18 years of age
• A positive stress test or symptoms related to stable CAD
• Patients who are scheduled for an elective PCI for 1 significant stenotic lesion ;Group B:
• Men and women > 18 years of age
• Patients with an acute coronary syndrome, defined as having unstable angina with elevated troponins
• During the coarse of the PCI procedure it has become clear that a single occlusion needs to be revascularised.;Group C:
• Men and women > 18 years
• Patients who are seen at the outpatient clinic and in whom cardiac disease is excluded
• Exclusion of cardiac disease is established by laboratory tests, electrocardiogram, echocardiography and/or an exercise test.
Exclusion criteria
Group A and B:;• Previous myocardial infarction
• Previous CABG
• Signs of AMI on ECG
• Moderate renal failure (eGFR <50ml/min)
• Concomitant inflammatory or malignant disease
• Presence of other serious medical conditions
• Unwillingness to sign informed consent;group C:;• Moderate renal failure (eGFR <50ml/min)
• Concomitant inflammatory or malignant disease
• Presence of other serious medical conditions
• Unwillingness to sign 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 | NL18735.042.07 |