Objective: To establish LV and RV geometry and function, and tissue characterization in age-and gender-matched healthy controls (serving as reference group for the CFS patients) by using own CE-CMR imaging.
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters will be LV and RV geometry and function (i.e., LV and
RV end-diastolic volume, end-systolic volume, end-diastolic wall mass, wall
motion score and ejection fraction) and tissue characterization of the
myocardium, to assess presence and extent of CE.
Secondary outcome
To assess the level of activity* in the healthy female volunteers in order to
correspond with the physically inactive CFS population and to assess if small
expected differences in LV/RV geometry, function and tissue characterization in
the female healthy subgroup can be explained by individual level of activity.
* The level of activity in the individual healthy volunteers is quantitatively
determined by (1) using a validated questionnaire and (2) completing a bicycle
exercise test.
Background summary
Rationale: Cardiovascular magnetic resonance (CMR) imaging is an accurate and
reproducible tool for the estimation of both left ventricular (LV) and right
ventricular (RV) geometry and function. CMR has also the unique capability to
obtain tissue characterization (i.e., presence and extent of scar/fibrosis) of
the myocardium after intravenous injection of a contrast agent. However, data
on reference values of RV and LV geometry and function, and tissue
characterization are scarce, and differences among age- and gender- matched
subgroups have been observed. Further, reference values with our own CMR
imaging modality have not been obtained.
Recently, we examined a small female chronic fatigue syndrome population (n=12,
age range 20-60) with contrast enhancement (CE)-CMR imaging to assess cardiac
involvement. We found relatively lower dimensions and a mildly reduced function
of the LV in comparison with age and gender-matched reference values. On the
CE-images, presence of myocardial fibrosis in some CFS patients was seen.
To improve the reliability of these data, it would be ideal to asses blinded,
at random parameters of LV and RV geometry and function and tissue
characterization in chronic fatigue syndrome patients as well as in age- and
sex- matched controls by using own CMR imaging modality.
Study objective
Objective: To establish LV and RV geometry and function, and tissue
characterization in age-and gender-matched healthy controls (serving as
reference group for the CFS patients) by using own CE-CMR imaging.
Study design
Study design:The Normal-CMR study is a single center case control study
Study burden and risks
Completing the questionnaire and bicycle exercise testing is not associated
with a risk.
During the CMR, the healthy volunteers will receive intravenously contrast in
order to perform myocardial tissue characterization. There is a hypothetical
risk of nephrogenic systemic fibrosis associated with gadolinium-based contrast
used in CMR. Nephrogenic systemic fibrosis occurs exclusively in patients with
kidney failure and as for this study only healthy volunteers are selected, it
is highly unlikely to occur. The incidence of systemic nephrogenic sclerosis
due to the contrast used in this study (see appendix B) is 0% according to the
manufacturer. CMR-scanning can be unpleasant to people with claustrophobia.
Haaksbergerstraat 55
Enschede 7513 ER
NL
Haaksbergerstraat 55
Enschede 7513 ER
NL
Listed location countries
Age
Inclusion criteria
Healthy female volunteers, age range 20-60 years.
Able to provide informed consent.
Exclusion criteria
Previous cardiovascular disease
known diseases with cardiac involvement
Unwillingness to use or contra-indications for contrast agents
Age < 20 or > 60 years
Pregnancy
Breast feeding
Kidney dysfunction
Body mass index > 30
Claustrophobia or other exclusion criteria for MRI such as implanted metal materials
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 | NL33018.044.10 |