coarctation of the aorta congenital heart disease
Conditions
Interventions
None listed
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
12 Years to 99 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| * 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
| Measure | Time frame |
|---|---|
| * 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. | — |
Countries
Netherlands
Outcome results
None listed