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

NCT02364193 | Completed

• 1 other identifier: NL50327.060.14
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Intrathoracic blood volume; Extravascular lung water

Outcome Measures

Primary Outcomes (1)

• Bolus kinetic parameters using Contrast-enhanced-MRI and BIS

  Correlation between changes in PTT and skewness of transpulmonary dilution system by DCE-MRI and changes in extravascular resistance measured by bio-impedance spectroscopy

  30 minutes

Secondary Outcomes (3)

• Fluid challenge response

  15 minutes

• Bolus kinetic parameters (Optimal DCE-MRI imaging sequence and range of normal values for ITBV, PTT and skewness of transpulmonary circulation measured by DCE-MRI in healthy subjects)

  5 minutes

• Bolus kinetic parameters and hemodynamic parameters.

  5 minutes

Study Arms (1)

Thoracic fluid status assessment

EXPERIMENTAL

Cardiac MRI by a 1.5 Tesla scanner: * Left ventricular ejection fraction (LVEF), tracing short axis endocardial borders. * CO, phase contrast angiography. * Fluid challenge by auto-transfusion by distal leg compression using inflatable cuffs (Lympamat Digital Gradient system). * DCE-MRI, bolus injection of Gd-CA intravenously by an injector. Each subject will receive repeated injections (10% of maximum dose). * BIS, impedance will be measured continuously using ImpediMed-SFB7 and surface electrodes on the thorax. .

Device: MRI; Drug: Gd-CA; Device: BIS ImpediMed™ SFB7; Device: Autotransfusion Lympamat Digital Gradient system

Interventions

MRI DEVICE

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

Thoracic fluid status assessment

Gd-CA DRUG

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.

Thoracic fluid status assessment

BIS ImpediMed™ SFB7 DEVICE

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.

Thoracic fluid status assessment

Autotransfusion Lympamat Digital Gradient system DEVICE

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

Thoracic fluid status assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years
• Informed consent.
• Body mass index between 18 and 25

You may not qualify if:

• 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

Sponsors & Collaborators

• Catharina Ziekenhuis Eindhoven: lead

Study Sites (1)

Catharina Hospital Eindhoven

Eindhoven, 4194 TR, Netherlands

Location

Study Officials

• Massimo Mischi, Msc PhD

  Eindhoven University of Technology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 16, 2015
• First Posted: February 18, 2015
• Study Start: March 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: January 28, 2016

Record last verified: 2016-01

Locations

NL (1)