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OpenTrials
Completed

NCT Number: NCT02616510

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

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.

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Key information

Conditions

Cardiovascular Diseases

Age range

45 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University Medical Center Utrecht

Utrecht, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age above 45 years

Exclusion criteria

  • none

Treatment and study plan

cardiovascular screening

Procedure

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

Primary outcomes

  1. carotid intima media thickness

    Time frame: 10 years post diagnosis

    ultrasound measurement of thickness of carotid wall (mean IMT), presence of atherosclerotic plaques (yes/no, location)

Secondary outcomes

  1. dyslipidemia

    Time frame: 10 years post diagnosis

    serum measurement of low density lipoprotein cholesterol, triglycerides, total cholesterol, high density lipoprotein cholesterol

  2. insulin and glucose levels

    Time frame: 10 years post diagnosis

  3. C-reactive protein

    Time frame: 10 years post diagnosis

  4. homocysteine

    Time frame: 10 years post diagnosis

  5. uric acid

    Time frame: 10 years post diagnosis

  6. androgen levels

    Time frame: 10 years post diagnosis

  7. electrocardiogram (ECG)

    Time frame: 10 years post diagnosis

    documentation of heart rythm, potential signs of ischemia (ST segment), length PR, QRS, QT, RR interval

  8. cardiac ultrasound (hypertrophy)

    Time frame: 10 years post diagnosis

    measurement of left ventricular ejection fraction and left ventricular mass,

Sponsors and collaborators

Lead sponsor

UMC Utrecht

Other

Collaborators

  • Amsterdam UMC, location VUmc
  • Erasmus Medical Center

Registry information

Acronym: POPCORn

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Nov 30, 2015
Registry last updated
Dec 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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