1. To investigate the causal relationships between atherosclerotic disease risk and existing, long-term cyanotic heart disease. 2. To differentiate these causal relationships according to each of the assessed risk factors and their relationship with…
ID
Source
Brief title
Condition
- Congenital cardiac disorders
- Lipid metabolism disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Intima-media thickness, a validated surrogate marker for atherosclerosis, is
the primary endpoint of the study.
Secondary outcome
Secondary endpoints entail anamnesis, medical history, serum lipid levels,
serum platelet count, serum bilirubin level, blood pressure and
electrocardiography.
Background summary
The Eisenmenger syndrome is the result of the systemic-to-pulmonary shunt
accompanied by cyanosis. In the Netherlands, it is estimated that there are at
least 200 adults with the Eisenmenger syndrome due to a congenital heart
defect. In the CONCOR-registry, a national data and DNA bank of adult patients
with a congenital heart disease, 95 patients have been included. These patients
with Eisenmenger syndrome have an increased risk of cerebrovascular accidents,
renal dysfunction, hemostatic abnormalities and haemoptysis.
In a recent study, it was suggested that there was a relationship between
cyanosis and a decreased cardiovascular disease risk. Patients with congenital
heart diseases appeared to have a lower total cholesterol and LDL cholesterol,
elevated HDL cholesterol in combination with antiatherosclerogenic effects like
low platelet count, hypoxemia, upregulation of nitric oxide and
hyperbilirubinemia.
To obtain better understanding of the development of atherosclerosis,
additional research is desirable. Another marker of early atherosclerotic
changes, the intima media thickness, can be used for this purpose. The intima
media thickness is measured non-invasively by ultrasonography.
Study objective
1. To investigate the causal relationships between atherosclerotic disease risk
and existing, long-term cyanotic heart disease.
2. To differentiate these causal relationships according to each of the
assessed risk factors and their relationship with duration and intensity of the
atherosclerotic disease.
Study design
This is a cross-sectional multi-centre case-control study
Study burden and risks
The subjects are evaluated once at the outpatient clinic. Anamnesis, medical
history, blood pressure, laboratory tests, electrocardiography and the
intima-media thickness are assessed. The intima-media thickness is measured
non-invasively by ultrasonography.
There are no serious adverse events expected of participation in this study, as
non of the participating subjects undergo invasive investigations.
Meibergdreef 9
1105 AZ
Nederland
Meibergdreef 9
1105 AZ
Nederland
Listed location countries
Age
Inclusion criteria
Older than 18 years:
1. Cyanotic heart disease from birth
2. Eisenmenger syndrome
3. Healthy control group consisting of relatives and acquaintances of participating patients
Exclusion criteria
Medical history with: thyroid disorder, malignancy, or recent surgery
Current pregnancy
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 | NL16208.018.07 |