The primary objective is to obtain data of invasively measured SAVI in patients with a normal aortic valves undergoing routine, clinically indicated, invasive cardiac catheterization..The secondary objective(s) is/are to investigate the correlation…
ID
Source
Brief title
Condition
- Cardiac valve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome will be purely descriptive and will include the calculation
of mean, median, range values of the invasively measured SAVI.
Secondary outcome
Correlation will be quantified by determining Peason's correlation coefficient
between the different parameters of interest when comparing SAVI physiology and
methodology (invasive versus non-invasive, with or without dobutamine).
Agreement will be assessed by performing a Bland-Altman analysis. We anticipate
that a two-dimensional scatterplot of SAVI (Ao/LV during dobutamine) versus
Ao/LV at baseline will show a large and unpredictable heterogeneity of
response, as we have already demonstrated for severe and low-gradient aortic
stenosis.
Background summary
Aortic valve physiology is in first instance assessed at rest by a standard
transthoracic echocardiogram (TTE). During this assessment the maximal aortic
valve velocity (AOV max), mean aortic gradient (MAG), and aortic valve area
(AVA) are quantified to grade the presence of aortic valve stenosis (AS).
Additionally an indexed AVA (cm2/m2) and velocity ratio (dimensionless index)
can be used to adjudicate the severity further. In European and American
guidelines the severity of any aortic valve stenosis is typically categorized
as none, mild, moderate, or severe. When in doubt of the severity of an aortic
stenosis, in particular cases, physicians can consider valvular stress testing
using exercise or dobutamine. However, all other measurements are performed at
rest, although patients generally complain of symptoms during exertion.
Therefore, the hypothesis has arisen that valvular stress testing might have
value beyond current guideline recommendations.
Our AoS-STRESS study already showed that a resting assessment of a stenotic
aortic valve could not predict its severity during stress conditions. It also
showed that AVA does not provide a valid physiological description of
hemodynamics since few valves display a quadratic pressure loss versus flow
profile. The limitations of AVA to grade the stenosis of AS or exclude the
presence of severe AS have also emerged in other, independent studies,
indicating the need for a new metric to quantify stenosis severity. We already
designed and validated a new tool to differentiate between AS severity in
patients undergoing transcatheter aortic valve implantation (TAVI). This
metric, the Stress Aortic Valve Index (SAVI), corresponded better to peak
transvalvular flow than resting measurements and gave a better understanding of
valve severity during stress conditions. Based on prior work, we reclassified
39% of valves in patients with low-gradient AS. At the moment we are conducting
another study (SAVI-AoS) to reclassify the severity of AS in patients with
unexplained symptoms and moderate AS, who based on their resting valve
quantification not are eligible for any form of intervention.
The goal of the current study is to measure the numeric distribution of SAVI
(invasive versus non-invasive) in patients with relatively normal aortic
valves. Based on earlier work SAVI <= 0.70 indicates severe AS. Our hypothesis
is that SAVI will correlate with classic echocardiographic measures of valve
severity and reach values near 1.0 when these traditional metrics are
completely normal. We have already validated (or are validating) SAVI in
patients with severe AS undergoing TAVI, in patients with moderate symptomatic
AS, in patients with normal and reduced left ventricular ejection fraction
(LVEF).
Study objective
The primary objective is to obtain data of invasively measured SAVI in patients
with a normal aortic valves undergoing routine, clinically indicated, invasive
cardiac catheterization..
The secondary objective(s) is/are to investigate the correlation and potential
agreement between the SAVI and standard echocardiographic metrics (MAG, AOV
max, and AVA).
Study design
This study will enroll an observational cohort of patients undergoing routine
cardiac catheterization. The indication for the cardiac catheterization will be
determined by the patient*s cardiologist and potential subjects will be
identified by local investigators through screening of healthcare databases and
lists for invasive cardiac catheterization. If a potential subject is
identified (for example, a patient with an intermediate coronary stenosis on
non-invasive referred for invasive study and potential treatment), than he or
she will be invited to join the study after review of inclusion/exclusion
criteria and providing informed consent as approved by each local MEC/IRB.
After informed consent has been given, visits will be planned for the
catheterization with invasive SAVI measurements. Stress echocardiography could
be performed during this procedure as well. The clinical catheterization will
contain additional research SAVI measurements that have been investigated in
two previous studies and are safe to use.
Study burden and risks
- adverse events to dobutamine
- standard risk of a cardiac catheterization
Michelangelolaan 2
Eindhoven 5623EJ
NL
Michelangelolaan 2
Eindhoven 5623EJ
NL
Listed location countries
Age
Inclusion criteria
- Age >= 18 years
- No important aortic stenosis (AVA > 1.5 cm2, MAG < 20 mmHg, AOV max <= 2.5
m/s) (note: high flow, high gradient is permitted if dimensionless index is
normal)
- Normal LVEF (>= 50%)
- Ability to undergo (exercise) stress testing
- Ability to understand and the willingness to provide written informed consent
Exclusion criteria
- Any hemodynamic criterion for moderate or greater AS
- Known, unrevascularized, and severe coronary artery disease (for example a
90% diameter stenosis or FFR<0.7 in the proximal left anterior descending
artery) (note: concurrent coronary artery percutaneous coronary intervention is
permitted)
- Impaired left ventricular function (ejection fraction <50%)
- Unicuspid and bicuspid observed during echocardiography (note that later cusp
fusion noted during study-related cardiac imaging will not exclude a subject)
- Severe aortic regurgitation, mitral valve disease, tricuspid regurgitation,
or a significant intracardiac shunt
- Co-existing hypertrophic cardiomyopathy or severe septal hypertrophy >15mm
- Persistent atrial fibrillation with uncontrolled ventricular response
- Recent (within 6 weeks) acute coronary syndrome
- Estimated glomerular filtration rate <=30 mL/min or end-stage renal disease on
replacement therapy (dialysis)
- Severe COPD GOLD stage 3 or 4, home oxygen dependence, or >=2 pulmonary
inhalers (note that well-treated and stable asthma and GOLD stage 1 or 2 COPD
is permitted)
- Severe comorbid condition with life expectancy <2 years
- Prior adverse reaction to dobutamine
- Severe iodine contrast allergy (note: well treatable contrast allergy is
permitted)
- Pregnancy
- Severe pulmonary hypertension with systolic pulmonary artery pressure greater
than 50mmHg or isolated and symptomatic right ventricular failure
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 | NL78962.100.21 |