|- candidate number||22998|
|- NTR Number||NTR5531|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||21-okt-2015|
|- Secondary IDs||NL52772.041.15 |
|- Public Title||Cardiovasculair RisicoprofiEl: IMAGing en reprOductieve aandoeningen|
|- Scientific Title||Cardiovascular RiskprofilE: IMaging And Gender-specific disOrders|
|- hypothesis||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.|
|- Healt Condition(s) or Problem(s) studied||Cardiovascular disease risk, Imaging, Fertility problems|
|- Inclusion criteria|| Age above 45 years old|
Capable and willing to provide informed consent.
Fulfil criteria for diagnosis PE / HELLP syndrome OR fulfil criteria for diagnosis PCOS OR fulfil criteria for diagnosis POI
|- Exclusion criteria|| Patients with insufficient mastery of Dutch.|
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.
|- mec approval received||no|
|- multicenter trial||yes|
|- planned startdate ||1-nov-2015|
|- planned closingdate|
|- Target number of participants||600|
|- Interventions||- Low-dose coronary Computed Tomography (CCT), with both non-contrast CT for coronary artery calcium scoring (CACS) and contrast-enhanced CT coronary angiography (CCTA).|
- Non-invasive vascular measurements; pulse wave velocity (PWV)
|- Primary outcome|| Coronary plaque measured by Coronary Computed Tomography (CCT) including both non-contrast coronary calcium scoring (CACS) and contrast enhanced coronary CT (CCTA).
Coronary artery stenosis measured by CCTA.
Biomarkers parameters: plasma CECs, extracellular vesicle protein- and miRNA-concentration, and plasma gene expression profiles in circulating endothelial cells. Numbers, subtype distribution and epigenetic profiles of inflammatory genes of circulating cells.
Vascular measurements (arterial stiffness)|
|- Secondary outcome||Traditional CVD risk factors (information collected as part of regular cardiovascular screening).|
|- Timepoints||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. |
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||drs. G.A. Zoet|
|- CONTACT for SCIENTIFIC QUERIES||drs. G.A. Zoet|
|- Sponsor/Initiator ||University Medical Center Utrecht (UMCU)|
(Source(s) of Monetary or Material Support)
|Dutch Heart Foundation (Nederlandse Hartstichting)|
|- Brief summary||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.
|- Main changes (audit trail)|
|- RECORD||21-okt-2015 - 27-jan-2016|