Cardiovasculair RisicoprofiEl: IMAGing en reprOductieve aandoeningen

Cardiovascular RiskprofilE: IMaging And Gender-specific disOrders

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON22481

Enrollment

600

Registered

2015-10-21

Start date

2015-11-01

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Reproductive disorders, polycystic ovary syndrome (PCOS), preeclampsia, primary ovarian insufficiency, migraine, venous thromboembolism, cardiovascular disease, risk prediction, coronary computed tomography (CCT) Reproductieve aandoeningen, polycysteus ovariumsyndroom (PCOS), pre-eclampsie, primaire ovariële insufficiëntie, migraine, veneus tromboembolisme, cardiovasculaire aandoeningen, risico predictie, coronaire computertomografie (CCT)

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). - Biomarkers - Non-invasive

pulse wave velocity (PWV)

Eligibility

Inclusion criteria

Inclusion criteria: • Age above 45 years old • Female • 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

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.

Design outcomes

Primary

Measure	Time frame
• 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)	—

Measure

Time frame

• 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

Measure	Time frame
Traditional CVD risk factors (information collected as part of regular cardiovascular screening).	—

Contacts

Public ContactG.A. Zoet

Wilhelmina Childrens Hospital Birth Center,

Email: gzoet@umcutrecht.nlTel: 088-7557526

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)