1. To investigate non-invasive 4D flow CMR for the assessment of aortic arch stenosis and compare and correlate this to conventional imaging modalities and to three-dimensional rotational angiography (3DRA) with computational fluid dynamics (CFD). 2…
ID
Source
Brief title
Condition
- Congenital cardiac disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
* flow qualification in the aorta and across the four cardiac valves.
* flow quantification in the aorta and across the four cardiac valves (in mL).
Secondary outcome
* wall shear stress.
* pressure difference.
* pulse wave velocity.
* turbulent kinetic energy.
* viscous energy losses.
* standardized flow parameters.
* peak velocity.
* acquisition time.
* post-processing time.
* Inter-observer agreement.
* Difference in stroke volumes over the cardiac valves in the absence of
shunting or valvular regurgitation.
Background summary
Standard assessment of aortic coarctation (CoA) consists of static imaging
techniques (diameter) and pressure measurements (measured invasively). The
novel, four-dimensional flow cardiac magnetic resonance (4D flow CMR) technique
allows for a more comprehensive evaluation of the thoracic aorta flow,
including the site of coarctation. 4D Flow CMR provides a non-invasive method
for the qualitative and quantitative characterization of blood flow and can be
used to derive advanced hemodynamic measures without radiation burden. Hereby,
4D flow CMR provides an integrated imaging modality to fully understand the
substrates of CoA, with the potential to improve patient identification, risk
stratification, follow-up, and treatment, and to reduce unnecessary, invasive
angiography.
Study objective
1. To investigate non-invasive 4D flow CMR for the assessment of aortic arch
stenosis and compare and correlate this to conventional imaging modalities and
to three-dimensional rotational angiography (3DRA) with computational fluid
dynamics (CFD).
2. To investigate 4D flow CMR for the assessment of flow across the cardiac
valves and compare to conventional 2D CMR.
Study design
Prospective, mono-center, diagnostic cross-sectional study.
Study burden and risks
The only burden is a longer duration of the CMRm, with <10 minutes. This CMR is
standard of care, as well as the follow-up CMR 1 month after intervention (if
applicable). According to the risk classification advise of the Federation of
University Medical centers (hulplijst risicoclassificatie uit NFU advies
kwaliteitsborging mensgebonden onderzoek) the study has to be graded as
negligible risk.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Subject is at least 12 years of age
- Subject is being (re-)assessed for (re-)coarctation aorta
- Individual agrees to have all study procedures performed, and is competent and willing to provide written informed consent to participate in this clinical study. ;In order to be eligible to participate in this study, a subject in the control group must meet all of the following criteria:
- Subject is at least 12years of age
- Subject (and parents/legal guardians if under 18 years of age) agrees to have CMR study procedures performed, and is competent and willing to provide written informed consent to participate in this clinical study.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Subject is younger than 12 years of age.
- Subject has any serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or the study
- Individual is pregnant, nursing or planning to be pregnant.
- Individual has a known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable to comply with study follow-up requirements.
- Refusal to be informed about potential additional CMR findings
- Subjects with an eGFR <30mL/min.
- Individual in control group has any condition that according to the investigators might
influence aortic flow.
- Subjects with any contraindications for CMR:
a. The presence of implanted non-CMR-compatible cardiac pacemaker or implanted cardioverter defibrillator.
b. Implanted electronic devices like cochlear implants and nerve stimulators.
c. Patients who are unable to fit into the bore of the magnet.
d. Claustrophobia
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 | NL57178.041.16 |