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Four-dimensional flow cardiac magnetic resonance imaging for the assessment of coarctation of the aorta, a monocenter, prospective, diagnostic cross-sectional study.

Recruiting
Conditions
coarctation of the aorta
congenital heart disease
10010394
Registration Number
NL-OMON43033
Lead Sponsor
niversitair Medisch Centrum Utrecht
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
30
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

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>* flow qualification in the aorta and across the four cardiac valves.<br /><br>* flow quantification in the aorta and across the four cardiac valves (in mL).</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>* wall shear stress.<br /><br>* pressure difference.<br /><br>* pulse wave velocity.<br /><br>* turbulent kinetic energy.<br /><br>* viscous energy losses.<br /><br>* standardized flow parameters.<br /><br>* peak velocity.<br /><br>* acquisition time.<br /><br>* post-processing time.<br /><br>* Inter-observer agreement.<br /><br>* Difference in stroke volumes over the cardiac valves in the absence of<br /><br>shunting or valvular regurgitation.</p><br>
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