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 个研究点目标入组 30 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

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•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.

•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

发起方

niversitair Medisch Centrum Utrecht