Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT05161884 |
Other study ID # |
EA4/118/20 |
Secondary ID |
|
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
April 1, 2021 |
Est. completion date |
December 31, 2024 |
Study information
Verified date |
September 2023 |
Source |
German Heart Institute |
Contact |
Sebastian Kelle, MD, PhD |
Phone |
00493045932400 |
Email |
kelle[@]dhzb.de |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
BOLD measured with MRI may be a useful noninvasive method for the assessment of right
ventricular O2 saturation. A validation of this method against right heart catheterization
has not been fully performed. Whether the method may have a diagnostic and prognostic role in
chronic heart failure patients is unclear.
Description:
Measurement of blood oxygen saturation (O2 saturation) is essential for the clinical
evaluation of patients with cardiovascular disease, heart failure, and pulmonary disease.
With the introduction of the right heart catheter, measurements of O2 saturation in the right
heart, venae cavae, and pulmonary artery became readily available and have thus contributed
significantly to our hemodynamic understanding of congenital and acquired heart disease.
Furthermore, the introduction of a pulmonary artery catheter, which can be implanted within
minutes at the bedside, allows better monitoring for critically ill patients in the intensive
care unit. In acquired heart disease, O2 saturation provides important information about
systemic oxygen delivery and consumption, making it essential for evaluating heart failure
patients and patients with pulmonary arterial hypertension. Nevertheless, invasive catheter
implantation is associated with not insignificant risks of complications and a noninvasive
method has not yet been established.
The blood oxygen level-dependent (BOLD) effect has been established in recent years as an
effective method to noninvasively measure O2 saturation using T2 magnetic resonance imaging
(T2-MRI). BOLD effect-based oximetry has been found to provide noninvasive information about
both blood oxygenation, myocardial oxygenation, and skeletal muscle oxygenation using MRI.
The principle underlying this technique exploits the dependence of the T2- relaxation time on
the oxygenation of hemoglobin, as well as the different magnetic properties of hemoglobin in
the oxygenated and deoxygenated states. To establish the mathematical relationship between
the T2 relaxation time of whole blood and O2 saturation, a Luz-Meiboom (L-M) model describing
the transverse (T2) relaxation arising from the transfer of protons between a protein and a
water solution was proposed. The application of this model has improved the "classical" BOLD
sequences, which were only measurable in static tissue (myocardium), minimizing the large
estimation variability in flows (ventricles and vessels), allowing a more quantitative
measurement. With the increasing number of patients receiving transcatheter aortic valve
implantation (TAVI) as well as being diagnosed with atypical pulmonary hypertension, a large
number of patients with relevant comorbidities require invasive hemodynamic evaluation.
Simultaneous evaluation of central venous SO2 (ScvO2) and cardiac function is highly
desirable and could allow noninvasive staging of frail high-risk patients. The first pilot
clinical study of this concept was recently published.
The first aim of the investigators is to determine the precision of non-invasive O2
saturation measurement using BOLD-T2-MRI in contrast to invasive O2 saturation measurement
using a right heart catheter in patients.
The secondary objective of the study is to investigate the role of BOLD measurements as a
diagnostic test in patients with dyspnea at presentation, at least NYHA class 2 and an
indication for cardio MRI. In these patients, BOLD measurements will be performed both at
rest and during exercise. A sensitivity analysis will be performed to determine the
diagnostic value of BOLD measurements in different patient populations.