Assessment of coronary artery disease (plaque and stenosis) by low-dose coronary Computed Tomography (CCT), with both non-contrast CT for coronary artery calcium scoring (CACS) and contrast-enhanced CT coronary angiography (CCTA) and additionally a…
ID
Source
Brief title
Condition
- Other condition
- Coronary artery disorders
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Health condition
reproductieve aandoeningen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Assessment of coronary artery disease (plaque and stenosis) by CCT (both CACS
and CCTA) and carotid siphon CT in patients with a reproductive disorder and
who are at least 40 years old to improve diagnostic evaluation of
cardiovascular risk factors.
Secondary outcome
To compare imaging markers of cardiovascular disease (plaque and stenosis
measured by CCT) with standardized vascular screening.
To construct and improve prediction models for the onset of CVD in these
patients.
Background summary
Reproductive disorders, including polycystic ovary syndrome (PCOS), primary
ovarian insufficiency (POI) and preeclampsia (PE), are associated with an
increased risk of cardiovascular diseases (CVD). Similar, migraine and venous
thromboembolism (VTE), both common among fertile women, can be considered as
female-specific CVD risk factors. Despite recent advances in long term
follow-up after reproductive disorders, identifying women who are at risk for
CVD remains a challenge. The current CVD risk profile of these young women
underestimates future cardiovascular health risks, as the most important
contribution in estimating ones risk of CVD is age. The aim of this study is to
develop and validate CVD risk evaluation imaging strategies and thereby improve
identification of women with (pre)clinical CVD.
Study objective
Assessment of coronary artery disease (plaque and stenosis) by low-dose
coronary Computed Tomography (CCT), with both non-contrast CT for coronary
artery calcium scoring (CACS) and contrast-enhanced CT coronary angiography
(CCTA) and additionally a non-contrast carotid siphon CT, in patients with a
history of a reproductive disorder to improve diagnostic evaluation of CVD risk
factors.
Study design
Multicentre, prospective, cohort follow-up study
Study burden and risks
Patients undergoing coronary CT (non-contrast CT for CACS and contrast-enhanced
CCTA) and carotid siphon CT will experience an average radiation dose of
3.3-3.4 mSv. This dose is corresponds to the yearly background radiation each
person receives in Europe and it is considered low-risk, i.e. a negligible
increase in the expected lifetime malignancy risk [Wall 1997, Schussler 2005,
Picano 2004]. Other risks of this study are considered negligible. Patients can
potentially benefit from information obtained in this study about their current
cardiovascular health and expected future risk of cardiovascular events.
Lundlaan 6
Utrecht 3508AB
NL
Lundlaan 6
Utrecht 3508AB
NL
Listed location countries
Age
Inclusion criteria
* Age 40 years or older
* Female
* Capable and willing to provide informed consent.
* Fulfil criteria for diagnosis of hypertensive pregnancy disorders OR fulfil criteria for diagnosis PCOS OR fulfil criteria for diagnosis POI
Exclusion criteria
* Patients with insufficient mastery of Dutch or English.
* Patients with any serious illness that can compromise study participation.
* Patient who have had a myocardial infarction.
* Patients with high risk for contrast nephropathy (renal function disorder).
* Patients with a history of allergy to iodinated contrast medium.
* Patients who are currently pregnant.;Healthy controls: history of hypertensive pregnancy disorders
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL52772.041.15 |
| Other | Nog niet bekend |
| OMON | NL-OMON22481 |