The main objective in this explorative study is to perform 4D flow MRI measurement in the reimplanted coronary arteries in arterial switch patients to give insight into the coronary blood flow patterns and investigate the impact of anatomical high…
ID
Source
Brief title
Condition
- Congenital cardiac disorders
- Cardiac and vascular disorders congenital
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Measurements 4D flow coronary arteries:
- qualitative: flow patterns (viewed dynamically in 3D)
- flow quantification: symmetry/asymmetry of bloodstream profiles
Secondary outcome
Secondary objectives include the study of advanced hemodynamic parameters
including regional wall shear stress (WSS).
Background summary
Transposition of the great arteries (TGA) is a congenital heart defect and
represents 5% to 7% of all congenital heart diseases (CHD). Nowadays, the
arterial switch operation (ASO) is the operation of choice for anatomical
correction in newborns with TGA. After a transition period in the 1980*s it has
replaced the Senning and Mustard atrial switch. Translocation of the coronary
arteries is the most critical step during the arterial switch procedure.
Coronary events are an important cause of death and most often occur within the
first year after ASO. The incidence of coronary events during adulthood is low,
however the adult ASO population is young and follow-up is therefore limited.
Most patients are reaching adulthood now. In previous studies, routine coronary
imaging with coronary computer tomography (cCT) in ASO adults showed that
anatomical high risk features of the coronary arteries including acute angle,
kinking, interarterial course were commonly found. These anatomical features
may be related to growth of the neo-aorta and proximal coronary arteries during
lifetime. However, the precise impact on flow patterns, shear stress on the
coronary wall, and juvenile atherosclerotic changes in the coronary arteries is
unknown. It is suspected that altered hemodynamics in the proximal coronaries
due to presence of anatomical high-risk features causes early atherosclerosis
and chronic ischemia in TGA-ASO patients.
Study objective
The main objective in this explorative study is to perform 4D flow MRI
measurement in the reimplanted coronary arteries in arterial switch patients to
give insight into the coronary blood flow patterns and investigate the impact
of anatomical high risk feautures on coronary hemodynamics.
Study design
A cross sectional, observationa and explorativel cohort study. We will perform
4D flow measurements of the coronary arteries additional to the routine cardiac
MRI examination.
Study burden and risks
4D flow measurement will be performed additional to the standard follow-up MRI.
As a consequence the duration of the MRI examination will extend with 25-30
minutes. The total duration of MRI examination will be therefore 55-60 min. The
nature of this study is exploratory, to discover new insights in the blood flow
dynamics of the coronary arteries after arterial switch and investigate the
impact of anatomical high-risk features. For each patient, flow measurements
outcome will be interpreted in relation to the clinical condition and
additional standard care examinations (cCT, exercisetest, and
echocardiography).
meibergdreef 9
Amsterdam 1105 AZ
NL
meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
- Patients with a transposition of the great arteries who underwent an arterial
switch operation
- Patients with clinical follow-up in the AMC and CONCOR registration
- 18 years or older
- Patients with a clinical indication for MRI examination
Exclusion criteria
- contraindication voor MRI
- claustrophobia
- mental retardation
- pregnancy
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL77087.018.21 |