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Primary Ovarian Insufficiency, Polycystic Ovary Syndrome & the CardiOvascular Risk Profile

Primary Ovarian Insufficiency, Polycystic Ovary Syndrome & the CardiOvascular Risk Profile

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02616510
Acronym
POPCORn
Enrollment
125
Registered
2015-11-30
Start date
2013-07-31
Completion date
2017-12-31
Last updated
2018-12-11

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

Conditions

Cardiovascular Diseases

Brief summary

The polycystic ovary syndrome (PCOS) is the most common endocrinopathy amongst women of reproductive age. PCOS is associated with various cardiovascular risk factors such as obesity, glucose intolerance, dyslipidemia hypertension and the metabolic syndrome. Whether these increased cardiovascular risk factors result in the development of actual cardiovascular disease in later life remains to be established. Women with premature ovarian insufficiency (POI), experience menopause prior to the age of 40 years. Women with POI may exhibit dyslipidemia. A young age at menopause has been previously associated with increased cardiovascular morbidity and mortality.

Detailed description

Cardiovascular risk profile will be assessed in women with PCOS and POI \> 45 years of age, consisting of: fasting serum and urine analyses blood pressure, length, weight, waist circumference, hip circumference ECG carotid intima media thickness cardiac ultrasound spare serum, plasma and urine will be stored in -80 degrees celsius biobank.

Interventions

PROCEDUREcardiovascular screening

cardiovascular screening: serum, urine, ECG, carotid intima media thickness (IMT), cardiac ultrasound

Sponsors

Amsterdam UMC, location VUmc
CollaboratorOTHER
Erasmus Medical Center
CollaboratorOTHER
UMC Utrecht
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
45 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* age above 45 years

Exclusion criteria

* none

Design outcomes

Primary

MeasureTime frameDescription
carotid intima media thickness10 years post diagnosisultrasound measurement of thickness of carotid wall (mean IMT), presence of atherosclerotic plaques (yes/no, location)

Secondary

MeasureTime frameDescription
dyslipidemia10 years post diagnosisserum measurement of low density lipoprotein cholesterol, triglycerides, total cholesterol, high density lipoprotein cholesterol
insulin and glucose levels10 years post diagnosis
homocysteine10 years post diagnosis
C-reactive protein10 years post diagnosis
androgen levels10 years post diagnosis
electrocardiogram (ECG)10 years post diagnosisdocumentation of heart rythm, potential signs of ischemia (ST segment), length PR, QRS, QT, RR interval
cardiac ultrasound (hypertrophy)10 years post diagnosismeasurement of left ventricular ejection fraction and left ventricular mass,
uric acid10 years post diagnosis

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026