This study aims to investigate the coronary artery system in women with axSpA by examining both morphological and functional parameters, encompassing macro- and microvascular function.
ID
Source
Brief title
Condition
- Coronary artery disorders
- Autoimmune disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoints of this study are:
- CAC-score
-->Calciumscore (low, medium,high)
Secondary outcome
->Endpoints derived from CMR (morphologic and functional parameters)
->Endpoints derived from CT coronary angiography (morphologic and functional
parameters)
-> Features on electrocardiogram
-> The cardiovascular risk profile:
a. Lipid profile: HDL cholesterol, LDL cholesterol, total cholesterol,
triglycerides, apolipoprotein A-1 and apolipoprotein B
b. Biomarkers of inflammation, including C-reactive protein and erythrocyte
sedimentation rate
c. Hemodynamic parameters: blood pressure, pulse rate.
d. SCORE2 risk prediction
Background summary
The present study proposes to estimate more accurately the cardiovascular (CV)
risk and the pathophysiology of coronary artery disease (CAD) in women and men
with axial spondyloarthritis (axSpA). While CV risk, beyond traditional risk
factors, may differ between women and men in this patient group, it may also be
higher compared to age-matched individuals in the general population. Recent
studies have shown that women are more likely than men to develop coronary
vasomotor/microvascular dysfunction (CMD). While the risk of developing new
cardiovascular (CV) acute events, such as myocardial infarction and stroke, has
been previously explored in axSpA and found to be increased, also due to higher
prevalence of traditional CV risk factors, there remains a substantial gap in
our understanding of the cardiac and coronary health of these patients.
Until now, there are no studies that have explored this aspect and have
addressed sex differences in morphological and functional parameters of the
cardiac system of individuals with axSpA by means of advanced technological
modalities such as cardiac MRI and CT.
These approaches are essential because traditional cardiovascular risk factors
may underestimate the risk of developing cardiovascular disease in individuals
with rheumatic conditions.
Study objective
This study aims to investigate the coronary artery system in women with axSpA
by examining both morphological and functional parameters, encompassing macro-
and microvascular function.
Study design
A cross-sectional, descriptive study.
Study burden and risks
There are minimal risks for subjects included in this study.
Although CMR is free from ionizing radiation, participating patients will be
exposed to a an effective dose of ~ 4.2 mSv due to serial CCTA imaging.
In addition, the contrast media may be nephrotoxic and elicit allergic
reactions. Peripheral blood samples will be taken once, which may cause some
discomfort.
Geert Groteplein Zuid 10
Nijmegen 6525 GA
NL
Geert Groteplein Zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, patients must meet all of
the following criteria:
• 18 years or older
• radiographic axial spondyloarthritis according to ASAS criteria: Assessment
of Spondyloarthritis International Society (ASAS)
• HLA-B27 positive
• Able to read, write and sufficiently communicate in Dutch
• Written informed consent
Exclusion criteria
• Contraindications to CMR or CCTA (e.g. claustrophobia, ferromagnetic
implants, known allergy to iodinated or gadolinium-based contrast agents,
weight or size exceeding the limits of the CMR or CCTA scanner.
• Contraindications to intravenous adenosine administration (e.g. Chronic
Obstructive Pulmonary Disease stage IV or asthma, systemic hypotension with
mean arterial blood pressure <70mmHg, second- or third-degree AV nodal
conduction disturbances
• Known GFR < 30 ml/min
• 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 | NL87327.091.24 |