Primary objectiveIs RRSO at age
ID
Source
Brief title
Condition
- Menopause related conditions
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 <
55 years, women < 65 years), body mass index, waist-hip ratio, physical
activity, menopausal symptoms, current or previous use of hormone replacement
therapy and a history of breast cancer treated with chemotherapy and/or
radiotherapy.
Secondary outcome
menopausal symptoms assessed with Greene Climacteric Scale
Background summary
Early menopause leads to an increased cardiovascular (CV) risk which might be
more pronounced in women with artificial menopause compared to natural
menopause. BRCA1/2 mutation carriers are generally exposed to an earlier
surgical menopause, because they are strongly recommended to undergo an
risk-reducing salpingo-oophorectomy (RRSO) around the age of 40 to reduce their
elevated risk of ovarian cancer. Until now, CV risk in BRCA1/2 mutation
carriers after RRSO is not yet studied.
CV risk assessment based on traditional risk factors often underestimates the
actual risk in middle-aged women. Measures of subclinical atherosclerosis such
as increased pulse wave velocity (PVW) and common carotid artery intima-media
thickness (CCA-IMT) predict future CV events in this group.
Study objective
Primary objective
Is RRSO at age <= 45 in BRCA1/2 mutation carriers a risk factor for development
of subclinical atherosclerosis, independent of traditional cardiovascular risk
factors?
Secondary objective
Are menopausal symptoms in BRCA1/2 mutation carriers with RRSO <= 45 years
associated with subclinical atherosclerosis?
Study design
a single-institute cohort study
Study burden and risks
The extent of burden associated with participation will be very low.
Participants will be asked to fill in a questionnaire once. Furthermore, all
women will be invited for a single visit to participate in a cardiovascular
screening progam at the Radboudumc in Nijmgen. One blood sample will be
collected and non-invasive measurements of atherosclerosis will be performed
using ultrasound. In total, it will consist a time investment of approximately
two hours.
Geert Grooteplein Zuid 10
Nijmegen 6525GA
NL
Geert Grooteplein Zuid 10
Nijmegen 6525GA
NL
Listed location countries
Age
Inclusion criteria
Women carrying a BRCA1 or BRCA2 mutation
RRSO at age 45 or younger
RRSO performed at least five years ago
Exclusion criteria
Women with (previous) ovarian cancer
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL51609.091.15 |