Aortic coarctation narrowing of the aorta
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Subject has been diagnosed with CoA. - Subject has previously undergone a surgical or transcatheter (balloon dilatation or stenting) intervention for CoA. - A previous CMR has been performed on the subject. - Subject is at least 16 years of age. - Subject is competent to understand the performed procedures, the potential hazards associated with these procedures, and to provide written informed consent.
Exclusion criteria
Exclusion criteria: - Subject with thoracic aortic dissection prior to study period. - Subject who underwent an intervention for an aneurysm of the ascending aorta prior to study period. - Subject is currently pregnant or has been pregnant during the study period. - Subject has a medical condition which, in the opinion of the investigator, could adversely affect the subject*s safety and/or the interpretation of the results. - Subject with a contraindication for CMR with administration of gadolinium-based contrast agent: • Cardiac pacemaker or implanted cardioverter defibrillator not compatible with CMR. • Electronic device or implant, such as cochlear implant or insulin pump. • Past adverse reaction to gadolinium-based contrast agents. • Severe renal insufficiency (creatinine clearance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CMR: - Dilatation rate of the aortic root and ascending aorta (mm/year) | — |
Secondary
| Measure | Time frame |
|---|---|
| CMR: - Total aortic volume expansion (mL/year) - Myocardial fibrotic size by T1-mapping and LGE (% of LV myocardium) - Pulse wave velocity (m/s) - Distensibility of ascending aorta (mmHg*1) - Left and right ventricular ejection fraction (%) - Longitudinal strain in 2- and 4-chamber long-axis views (%) - Circumferential strain at apical, mid-ventricular and basal LV levels (%) - LV end-diastolic volume indexed to body surface area (mL/m2) - LV end-systolic volume indexed to body surface area (mL/m2) - LV mass indexed to body surface area (g/m2) - Septal and posterior wall thickness (cm) Transthoracic echocardiography: - Aortic diameter at the level of the aortic root (mm) - Peak-to-peak systolic pressure gradient across coarctation site (mmHg) - Peak velocity at coarctation site (m/s) - E/A ratio Exercise testing: - Peak exercise systolic blood pressure (mmHg) 24-hour ambulatory blood pressure monitoring: - Mean 24-hour systolic blood pressure (mmHg) - Mean 24-hour diastolic blood pressure (mmHg) | — |
Countries
Netherlands