1. To identify the patients at risk for aortic aneurysms after PDA closure.We expect to find a decreased distensibility of the aorta in this subgroup of patients which will be examined by MRI. Besides the functional MRI study genetic testing of theā¦
ID
Source
Brief title
Condition
- Cardiac and vascular disorders congenital
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
MRI-scanning:
difference in aortic distensibility between patients and controls.
Genetic testing:
presence of a predisposing mutation known to be associated with inheritable
aortic dissection and/or PDA.
Secondary outcome
not applicable
Background summary
Ductal closure by the means of catheter intervention is nowadays the standard
treatment for PDA. Clinical follow-up is normally discontinued after
documentation of a succesfull intervention. Data from animal studies suggest,
that there might be a subgroup of patients in which the PDA is part of a more
complex vascular disease. These patients might profit from specific
cardiovascular follow-up. Aim of the study is to identify the patients at risk
for aortic aneurysms after PDA-closure. In the past MRI has proven to be a
reliable diagnostic tool to investigate cardiovascular morfology and function.
In adolescents and young adults quality of echocardiographic images decreases.
The advantage of MRI imaging lies in its non-invasive nature and
reproducibility. Therefore MRI is an attractive method for this longitudinal
study.
Study objective
1. To identify the patients at risk for aortic aneurysms after PDA closure.
We expect to find a decreased distensibility of the aorta in this subgroup of
patients which will be examined by MRI. Besides the functional MRI study
genetic testing of the patients is intended. Predisposing mutations and DNA
loci known to be associated with inheritable aortic dissection and/or PDA.
2. To gain longterm data on possible aortic changes in patients after
PDA-closure.
3. To stratify the patientgroup with PDA by the need of follow-up after ductal
closure.
Study design
prospective patient-based study
Study burden and risks
Burden of the patient/parents:
1. completion of a questionnaire: burden minimal, no risks.
2. MRI-scan: burden minimal: 2 hours study-time plus travel to the hospital,
no risks in probands without contraindications.
3. DNA-study: burden minimal: venipuncture: risk low, genetic counseling will
be offered to patients with clinical relevant results.
Albinusdreef 2
2300 RC Leiden
Nederland
Albinusdreef 2
2300 RC Leiden
Nederland
Listed location countries
Age
Inclusion criteria
Diagnosis of PDA or MARFAN, > 12 year
Exclusion criteria
1. Hemodynamically relevant residual cardiac anomalies
2. Genetic syndromes other than MARFAN
3. Contraindication against MRI-scanning (arrhythmias, pacemaker implantation, claustrophobia)
Design
Recruitment
metc-ldd@lumc.nl
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 | NL13585.058.06 |