NL-OMON43033
Recruiting
Not Applicable
Four-dimensional flow cardiac magnetic resonance imaging for the assessment of coarctation of the aorta, a monocenter, prospective, diagnostic cross-sectional study. - 4D flow CMR in coarctation of the aorta.
niversitair Medisch Centrum Utrecht0 sites30 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- coarctation of the aorta
- Sponsor
- niversitair Medisch Centrum Utrecht
- Enrollment
- 30
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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:
Outcomes
Primary Outcomes
Not specified
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