Thoracic Fluid Assessment by Contrast-enhanced Magnetic Resonance Imaging and Bioimpedance

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.

Conditions

• Pulmonary Congestion

Interventions

DEVICE

MRI

Cardiac MRI for LVEF and segmentation. * Phase-contrast MRI for CO in aorta and each pulmonary vein. * DCE-MRI for bolus kinetic parameter analysis.

DRUG

Gd-CA

Bolus kinetic parameter analysis, different doses of Gd-CA (Dotarem by Guerbet) ranging between 0.1 and 0.5 mmol will be injected intravenously after dilution in 5 milliliter saline by an injector at a speed of 5 ml/s.

DEVICE

BIS ImpediMed™ SFB7

BIS will be measured by Bio-impedance spectroscopy will be performed using ImpediMed™ SFB7 (ImpediMed Limited 2008). Impedance will be measured continuously during the fluid challenge and for maximum 600 seconds before and after the fluid challenge. Currents of different frequencies will be applied; the resulting voltage will be recorded, with a time resolution for the complete frequency span not lower than 2 seconds.

DEVICE

Autotransfusion Lympamat Digital Gradient system

Lympamat Digital Gradient system (Bosl, Aachen) inflatable leg compression trousers will induce an autotransfusion by compressing the legs with a maximum of 90 mmHg for a maximum of 300 seconds

Sponsors & Collaborators

• Catharina Ziekenhuis Eindhoven

  lead OTHER

Principal Investigators

• Massimo Mischi, Msc PhD · Eindhoven University of Technology

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2015-03-31

Primary Completion

2015-06-30

Completion

2015-06-30

Countries

• Netherlands

Study Locations