We aim to i) describe flow patterns and flow-related dynamics in the ascending aorta of patients with aortic valve stenosis, ii) compare these flow parameters before and after surgical aortic valve replacement and iii) compare flow parameters with…
ID
Source
Brief title
Condition
- Cardiac valve disorders
- Aneurysms and artery dissections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Description and quantification of blood flow parameters (e.g. flow patterns,
wall shear stress, peak flow velocity) in the proximal aorta and
characterization of the aortic vessel wall.
Secondary outcome
2. Aortic dimensions and quantification of aortic vessel wall microvasculature.
3. Left ventricular dimensions, function and mass.
Background summary
Cardiovascular Magnetic Resonance Imaging (MRI) is widely used for the
assessment of cardiovascular disease, providing both anatomical and
physiological information on the heart and great vessels. Four-dimensional (4D)
flow MRI, a relatively new MRI technique, allows for better visualization of
blood flow patterns and quantification of flow-related dynamics. This study
seeks to provide (patho)physiological information on aortic valve stenosis and
the often concomitantly observed dilation of the ascending aorta. Using 4D flow
MRI we will study various flow parameters (e.g. flow patterns, wall shear
stress etc.) in the aortic root and ascending aorta of different groups of
patients. Furthermore, we will use contrast-enhanced MRI (CE-MRI) to
investigate the role of inflammation (i.e. neovascularization) of the vessel
wall in the development of aortic dilatation. We hypothesize that i) aortic
valve stenosis leads to highly abnormal blood flow patterns in the ascending
aorta, ii) these flow alterations are accompanied by increased wall shear
stress on the aortic vessel wall and iii) i and ii contribute to the
development of aortic dilatation in patients with aortic valve stenosis
(so-called post-stenotic aortic dilatation). In post-stenotic dilatation, we do
not expect to find signs of an inflammatory process as seen in isolated aortic
aneurysms. A better understanding of dilatation of the aorta is important as it
will improve patient follow-up and stratification towards surgery.
Study objective
We aim to i) describe flow patterns and flow-related dynamics in the ascending
aorta of patients with aortic valve stenosis, ii) compare these flow parameters
before and after surgical aortic valve replacement and iii) compare flow
parameters with those in patients with isolated thoracic aortic aneurysm
(without concomitant aortic valve stenosis).
Study design
Prospective, observational (longitudinal cohort), single-center study,
conducted at the Maastricht University Medical Center (MUMC+).
Study burden and risks
This is an observational study which has no therapeutic consequences. 4D Flow
and contrast-enhanced (CE) MRI scan protocols are routinely used and thus
non-experimental. Participants are not subject to ionizing radiation. Low-dose
injection of Gadovist®, a standard gadolinium-based MRI contrast agent, will be
administered during CE-MRI scan protocol. Adverse reactions to gadolinium-based
contrast agents are rare, transient and generally well-tolerated. Patients with
severe chronic kidney disease will be excluded from participation in this
study, since cases of nephrogenic systemic fibrosis have been reported after
administration of gadolinium-based contrast agents in these patients. Study
results will improve understanding of post-stenotic proximal aortic dilatation.
In the future, this may give rise to the implementation of 4D flow MRI and
CE-MRI in patient follow-up and their stratification towards valvular and/or
aortic surgery.
P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
We defined the following groups for inclusion:
- Severe aortic stenosis (mean transvalvular gradient >40 mmHg or aortic valve area (AVA) *1.0 cm2).
- Non-severe aortic valve stenosis (mean transvalvular gradiënt 1-39 mmHg and AVA >1.0 cm2).
- Aortic aneurysm >45 mm (without aortic valve stenosis).
- Healthy volunteers (apparently free of cardiovascular disease). ;General inclusion criteria:
- Age >18 years old.
- Preserved left ventricular ejection fraction (LVEF >50%).
- Mentally competent.
- Signed informed written consent.
Exclusion criteria
- Age <18 years.
- Atrial fibrillation or tachycardia >100 bpm.
- Prior cardiac/aortic surgery.
- Decreased left ventricular ejection fraction (LVEF <50%).
- Heart failure (Killip class * III), cardiogenic shock or symptoms at rest.
- Congenital/genetic heart disease.
- Chronic kidney disease (eGFR <30 mL/min/1.73 m2).
- Connective tissue disorder (e.g. Marfan*s disease).
- Contra-indication for MRI-examination (Metallic implant (vascular clip, neuro-stimulator, cochlear implant), pacemaker or implantable cardiac defibrillator (ICD), claustrophobia, body weight >130 kg, prior adverse reaction to gadolinium-based contrast agents).
- Previous adverse reaction to gadolinium.
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 | NL56404.068.16 |