This study evaluates the normal range dynamic contrast-enhanced MRI bolus kinetic parameters in healthy subjects. The sensitivity of the bolus kinetic parameters to fluid challenges is evaluated. The correlation between change in thoracic impedance…
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
A. To optimize the DCE-MRI sequence parameters and to evaluate a reference
values for indicator dilution curves derived parameters in healthy volunteers
B. To evaluate whether bolus kinetic derived DCE-MRI parameters can track
changes in response to fluid challenge/auto-transfusion in healthy volunteers
C. To evaluate the agreement between changes in bolus kinetic parameters
measured by DCE-MRI and changes in impedance measured by bio-impedance
spectroscopy
Secondary outcome
A. To evaluate the relationship between bolus kinetic parameters and RV and LV
functional parameters.
B. To evaluate reproducibility of MR based bolus kinetic parameters measurement
and to evaluate sensitivity to MR sequence parameters.
Background summary
Heart failure is a major health problem, which is characterized by reduced
cardiac function leading to pulmonary congestion. Most episodes of acute heart
failure requiring unplanned hospitalization are due to pulmonary congestion.
There is urgent clinical need for quantitative, reproducible and minimally
invasive and noninvasive methods to assess thoracic fluid status. The potential
value of dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) to this
end has been suggested and demonstrated in vitro, and in this study we now aim
to compare intra-thoracic volume assessment by dynamic contrast-enhanced MRI
and bioimpedance spectroscopy.
Study objective
This study evaluates the normal range dynamic contrast-enhanced MRI bolus
kinetic parameters in healthy subjects. The sensitivity of the bolus kinetic
parameters to fluid challenges is evaluated. The correlation between change in
thoracic impedance and change in bolus kinetic parameters in response to a
fluid challenge is evaluated.
Study design
Prospective nonrandomized pilot study.
Study burden and risks
The whole study will take 3 hours of the volunteer's time. Gadolineum will be
injected however the amount will be 10% of the permitted dose.
To reduce the chance of harm, a creatinin clearance will be estimated in
advance. The chance on allergic reaction is smaller than 0.1% and in very rare
cases nefrogenic systemic fibrosis can be developed. This chance is larger in
patients with renal insufficiency and these volunteers are excluded from
participating the trial.
Deo et al reported in end-stage renal disease an incidence of 4.3 per 1000
patients for developtment of nephrogenic systemic fibrosis. Todd et al found an
increased risk to cutaneous changes of nephgenic systemic fibrosis, odds ratio
fo 14.7; 95% CI 1.9-117) compare with patients who were not exposed to
gadolineum
Michelangelolaan 2
Eindhoven 5623 EJ
NL
Michelangelolaan 2
Eindhoven 5623 EJ
NL
Listed location countries
Age
Inclusion criteria
• Age >18 years
• Informed consent.
• Body mass index between 18 and 25
Exclusion criteria
• end-stage renal or hepatic disease
• pregnancy
• mild or moderate renal insufficiency, (GFR<60 mL/min);
• risk for developing nephrogenic systemic fibrosis;
• general contra-indications to magnetic resonance imaging
• pro-inflammatory state, vascular endothelial dysfunction
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 | NL50327.060.14 |