Cardiovascular risk after risk-reducing salpingo-oophorectomy in BRCA1/2 mutation carriers: CARSOBRA study

Cardiovascular risk after risk-reducing salpingo-oophorectomy in BRCA1/2 mutation carriers: CARSOBRA study - CARSOBRA study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON42246

Enrollment

250

Registered

2015-05-28

Start date

2015-06-17

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

subclinical atherosclerosis

Interventions

BRCA1/2 mutation

cardiovascular risk

salpingo-oophorectomy

subclinical atherosclerosis

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Women carrying a BRCA1 or BRCA2 mutation RRSO at age 45 or younger RRSO performed at least five years ago

Exclusion criteria

Exclusion criteria: Women with (previous) ovarian cancer

Design outcomes

Primary

Measure	Time frame
Main study endpoints are CCA-IMT and PWV. Main study determinant is time since RRSO. Relevant covariates (confounding factors) are age, systolic blood pressure, medication use for blood pressure, smoking (pack-years of cigarette smoking and current smoking), insulin resistance, anti-diabetic medication use, fasting lipids, statin use, obstetric history of hypertensive disorders, family history of premature atherosclerosis (MI/stroke of first degree family: men	—

Measure

Time frame

Main study endpoints are CCA-IMT and PWV. Main study determinant is time since RRSO. Relevant covariates (confounding factors) are age, systolic blood pressure, medication use for blood pressure, smoking (pack-years of cigarette smoking and current smoking), insulin resistance, anti-diabetic medication use, fasting lipids, statin use, obstetric history of hypertensive disorders, family history of premature atherosclerosis (MI/stroke of first degree family: men

—

Secondary

Measure	Time frame
menopausal symptoms assessed with Greene Climacteric Scale	—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)