Cardiovasculair RisicoprofiEl: IMAGing en reprOductieve aandoeningen

Rationale: 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.

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), 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 population: Women who experienced 1 or more reproductive disorders (PCOS, POI, PE) and who are at least 45 years of age.

Intervention (if applicable): not applicable.
Main study parameters/endpoints: Assessment of coronary artery disease (plaque and stenosis) by CCT (both CACS and CCTA) in patients with a reproductive disorder to improve diagnostic evaluation of cardiovascular risk factors.

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), in patients with a history of a reproductive disorder to improve evaluation of CVD risk factors.

Planned start date: 1-11-2015
Interim analysis: after 300 CCT's (100 in patients with PE, 100 in patients with PCOS and 100 in patients with POI). If the prevalence of any plaque as seen on CCT is ¡Ý 10% we will continue with performing the remaining 300 CCT¡¯s.

- Low-dose coronary Computed Tomography (CCT), with both non-contrast CT for coronary artery calcium scoring (CACS) and contrast-enhanced CT coronary angiography (CCTA).

- Biomarkers

- Non-invasive vascular measurements; pulse wave velocity (PWV)