Characterization of ascending aortic flow patterns and vessel wall in patients with aortic valve stenosis before and after surgical valve replacement: a 4D Flow Magnetic Resonance Imaging study.

Completed

Conditions: Aortic valve stenosis
valvular heart disease.
10046973
10002363

Registration Number: NL-OMON43452

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 68

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.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. Description and quantification of blood flow parameters (e.g. flow patterns,<br /><br>wall shear stress, peak flow velocity) in the proximal aorta and<br /><br>characterization of the aortic vessel wall.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>2. Aortic dimensions and quantification of aortic vessel wall microvasculature.<br /><br>3. Left ventricular dimensions, function and mass.</p><br>