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

Cardiovascular Diseases Clinical Trial

— POPCORn  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02616510
• Other study ID #: 13-010
• Status: Completed
• Start date: July 2013
• Est. completion date: December 2017

Study information

• Verified date: December 2018
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

• age above 45 years

Exclusion Criteria:

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Gonadal Dysgenesis
• Menopause, Premature
• Polycystic Ovary Syndrome
• Primary Ovarian Insufficiency
• Turner Syndrome

Intervention

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

Locations

Country	Name	City	State
Netherlands	University Medical Center Utrecht	Utrecht

Sponsors (3)

Lead Sponsor	Collaborator
UMC Utrecht	Erasmus Medical Center, VU University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	carotid intima media thickness	ultrasound measurement of thickness of carotid wall (mean IMT), presence of atherosclerotic plaques (yes/no, location)	10 years post diagnosis
Secondary	dyslipidemia	serum measurement of low density lipoprotein cholesterol, triglycerides, total cholesterol, high density lipoprotein cholesterol	10 years post diagnosis
Secondary	insulin and glucose levels		10 years post diagnosis
Secondary	C-reactive protein		10 years post diagnosis
Secondary	homocysteine		10 years post diagnosis
Secondary	uric acid		10 years post diagnosis
Secondary	androgen levels		10 years post diagnosis
Secondary	electrocardiogram (ECG)	documentation of heart rythm, potential signs of ischemia (ST segment), length PR, QRS, QT, RR interval	10 years post diagnosis
Secondary	cardiac ultrasound (hypertrophy)	measurement of left ventricular ejection fraction and left ventricular mass,	10 years post diagnosis