Thoracic Fluid Assessment by Contrast-enhanced Magnetic Resonance Imaging and Bioimpedance
Status:
Completed
Trial end date:
2015-06-01
Target enrollment:
Participant gender:
Summary
Heart failure (HF) is a major health problem, which is characterized by reduced cardiac
function leading to pulmonary congestion. Most episodes of acute HF requiring unplanned
hospitalization are due to pulmonary congestion. There is an urgent clinical need for
quantitative, reproducible, 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. In this study the
investigators aim to compare intra-thoracic fluid volume assessed by DCE- MRI using bolus
kinetic parameters of the indicator dilution theory and bioimpedance spectroscopy (BIS).
Primary objectives: This study evaluates the correlation between change in BIS and change in
bolus kinetic parameters in response to a fluid challenge.
Secondary objectives: The sensitivity of the bolus kinetic parameters to fluid challenges and
the normal range DCE-MRI bolus kinetic parameters is evaluated in healthy subjects.
Study design: Prospective nonrandomized pilot study.
Study population: Healthy volunteers.
Intervention: The subjects will receive an intra-venous injection of gadolinium, a MRI
contrast agent. External pressure will be applied by means of a leg-compression device in
order to induce a rapid increase of the preload by blood auto-transfusion.
Main study parameters: Pulmonary transit time (PTT), skewness of the indicator dilution curve
which is a measure of trans-pulmonary dilution, intrathoracic blood volume (ITBV), changes in
bolus kinetic parameters, and thoracic impedance in response to fluid challenges. The
correlation between changes in bolus kinetic parameters and thoracic impedance in response to
fluid challenges.