The main objectives are :Cross-sectional:1. To investigate the extent of atherosclerotic disease of the carotid artery defined as: (a) the intima-media thickness (IMT) (b) the elasticity (c) the degree of stenosis2. To define the degree of…
ID
Source
Brief title
Condition
- Lymphomas Hodgkin's disease
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main parameters are the difference in IMT, the elasticity,the degree of
stenosis
between the irradiated group and the non-irradiated HL group and to the control
population.
The other main parameter is the extent of coronary atherosclerosis on MRI in
the two patients groups.
Secondary outcome
To investigate if inflammatory markers which are know to be increased in
age-related atherosclerosis are also increased in RT-induced atherosclerosis.
The amounts of cerebrovascular events; i.e. TIA or CVA and of cardiovascular
disease; i.e. angina pectoris, myocardial infarction, cardiomyopathy, cardiac
failure, rhythm-, conduction abnormalities and valvular dysfunction will be
studied. Also endocrine dysfunction will be assessed.
Background summary
To obtain insight in the pathogenesis and extent of cardio- and neuro-vascular
disease in survivors of Hodgkin*s lymphoma (HL) with respect to former
treatment modalities: radiotherapy (RT) and chemotherapy (CT).
Study objective
The main objectives are :
Cross-sectional:
1. To investigate the extent of atherosclerotic disease of the carotid artery
defined as:
(a) the intima-media thickness (IMT)
(b) the elasticity
(c) the degree of stenosis
2. To define the degree of atherosclerotic disease of the coronary system by
MRI.
Prospective:
To estimate the progress of the above mentioned research points, we will repeat
the measurement after 5 years of follow-up.
Study design
The study is a cross sectional cohort study. After 5 years a prospective study
will be conducted to estimate the progress of the above mentioned research
points.
Study burden and risks
Patients and controls participating in the study will be evaluated twice during
a total of 6 hours. The first visit consists of a global physical, neurological
examination and duplex scanning of the carotid artery. Also 5 tubes of blood
will be taken for base-line blood values and inflammatory markers. This visit
will last for a maximal 3 hours. During the second visit a MRI of the coronary
system is performed.
All procedures are with low risks and have a minimum of discomfort.
Koekoekslaan 1
3430 EM Nieuwegein
Nederland
Koekoekslaan 1
3430 EM Nieuwegein
Nederland
Listed location countries
Age
Inclusion criteria
Patients who have been treated for Hodgkin's lymphoma in the past and who survived at least 2 years. Age> 18 years.
Exclusion criteria
Psychiatric disease or inability to give 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 | NL12714.100.06 |