Cardiovascular DiseasesPOPCORnNCT02616510
Primary Ovarian Insufficiency, Polycystic Ovary Syndrome & the CardiOvascular Risk Profile
An observational study of Cardiovascular Diseases, run by UMC Utrecht at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 45 years and older, women only
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- cardiovascular screening
- Type of treatment
- Surgery or procedure
- How many people
- 125 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 2013to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: women with PCOS according to rotterdam criteria (2 or more of these criteria) * oligo/anovulation * polycystic ovarian morphology * hyperandrogenism Women with POI amenorrhea of at least 4 months prior to age 40 years with FSH levels above 40 IU/L
Who may be able to join
- age above 45 years
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Cardiovascular Diseases
- Being tested
- cardiovascular screening
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiovascular screeningProcedure or surgery
cardiovascular screening: serum, urine, ECG, carotid intima media thickness (IMT), cardiac ultrasound
| Study group | Role | What they receive |
|---|---|---|
| PCOS | Rotterdam criteria (at least 2 out of three criteria present) oligo-anovulation polycystic ovarian morphology hyperandrogenism Receives: Procedure: cardiovascular screening | |
| POI | amenorrhea of at least 4 months prior to age 40 years, with follicle stimulating hormone (FSH) levels above 40 IU/L Receives: Procedure: cardiovascular screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
carotid intima media thickness
ultrasound measurement of thickness of carotid wall (mean IMT), presence of atherosclerotic plaques (yes/no, location)
Measured: 10 years post diagnosis
Secondary outcomes (8)
dyslipidemia
serum measurement of low density lipoprotein cholesterol, triglycerides, total cholesterol, high density lipoprotein cholesterol
Measured: 10 years post diagnosis
insulin and glucose levels
Measured: 10 years post diagnosis
C-reactive protein
Measured: 10 years post diagnosis
homocysteine
Measured: 10 years post diagnosis
uric acid
Measured: 10 years post diagnosis
androgen levels
Measured: 10 years post diagnosis
electrocardiogram (ECG)
documentation of heart rythm, potential signs of ischemia (ST segment), length PR, QRS, QT, RR interval
Measured: 10 years post diagnosis
cardiac ultrasound (hypertrophy)
measurement of left ventricular ejection fraction and left ventricular mass,
Measured: 10 years post diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2015 (estimated)
- Study startJul 2013
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- Amsterdam UMC, location VUmc, Erasmus Medical Center
- Responsible party
- Principal investigator, Bart CJM Fauser, UMC Utrecht
- Investigators
- Bart Fauser, prof, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02616510
- Sponsor's protocol ID
- 13-010
- Acronym
- POPCORn
- Status last verified
- Dec 2018
- First submitted
- 20 Nov 2015
- Last updated
- 11 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gunning MN, Meun C, van Rijn BB, Daan NMP, Roeters van Lennep JE, Appelman Y, Boersma E, Hofstra L, Fauser CGKM, Rueda-Ochoa OL, Ikram MA, Kavousi M, Lambalk CB, Eijkemans MJC, Laven JSE, Fauser BCJM; CREW consortium. The cardiovascular risk profile of middle age women previously diagnosed with premature ovarian insufficiency: A case-control study. PLoS One. 2020 Mar 5;15(3):e0229576. doi: 10.1371/journal.pone.0229576. eCollection 2020.
PubMed 32134933Daan NM, Muka T, Koster MP, Roeters van Lennep JE, Lambalk CB, Laven JS, Fauser CG, Meun C, de Rijke YB, Boersma E, Franco OH, Kavousi M, Fauser BC. Cardiovascular Risk in Women With Premature Ovarian Insufficiency Compared to Premenopausal Women at Middle Age. J Clin Endocrinol Metab. 2016 Sep;101(9):3306-15. doi: 10.1210/jc.2016-1141. Epub 2016 Jun 14.
PubMed 27300572
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Ovarian Insufficiency, Polycystic Ovary Syndrome & the CardiOvascular Risk Profile
- ClinicalTrials.gov ID
- NCT02616510
- Acronym / sponsor ID
- POPCORn / 13-010
- Conditions
- Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- Amsterdam UMC, location VUmc, Erasmus Medical Center
- Study start
- Jul 2013
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 30 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCOS | – | Procedure: cardiovascular screeningRotterdam criteria (at least 2 out of three criteria present) oligo-anovulation polycystic ovarian morphology hyperandrogenism |
| POI | – | Procedure: cardiovascular screeningamenorrhea of at least 4 months prior to age 40 years, with follicle stimulating hormone (FSH) levels above 40 IU/L |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- women with PCOS according to rotterdam criteria (2 or more of these criteria) * oligo/anovulation * polycystic ovarian morphology * hyperandrogenism Women with POI amenorrhea of at least 4 months prior to age 40 years with FSH levels above 40 IU/L
Key inclusion criteria (1 listed)
- age above 45 years
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cardiovascular screeningcardiovascular screening: serum, urine, ECG, carotid intima media thickness (IMT), cardiac ultrasound | Procedure or surgery | PCOS, POI |
Primary outcome
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)
8 secondary outcomes
dyslipidemia
Time frame: 10 years post diagnosis
insulin and glucose levels
Time frame: 10 years post diagnosis
C-reactive protein
Time frame: 10 years post diagnosis
homocysteine
Time frame: 10 years post diagnosis
uric acid
Time frame: 10 years post diagnosis
androgen levels
Time frame: 10 years post diagnosis
electrocardiogram (ECG)
Time frame: 10 years post diagnosis
cardiac ultrasound (hypertrophy)
Time frame: 10 years post diagnosis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2018.
- Derived from this study: PubMed 32134933Gunning MN, Meun C, van Rijn BB, Daan NMP, Roeters van Lennep JE, Appelman Y, Boersma E, Hofstra L, Fauser CGKM, Rueda-Ochoa OL, Ikram MA, Kavousi M, Lambalk CB, Eijkemans MJC, Laven JSE, Fauser BCJM; CREW consortium. The cardiovascular risk profile of middle age women previously diagnosed with premature ovarian insufficiency: A case-control study. PLoS One. 2020 Mar 5;15(3):e0229576. doi: 10.1371/journal.pone.0229576. eCollection 2020.
- Derived from this study: PubMed 27300572Daan NM, Muka T, Koster MP, Roeters van Lennep JE, Lambalk CB, Laven JS, Fauser CG, Meun C, de Rijke YB, Boersma E, Franco OH, Kavousi M, Fauser BC. Cardiovascular Risk in Women With Premature Ovarian Insufficiency Compared to Premenopausal Women at Middle Age. J Clin Endocrinol Metab. 2016 Sep;101(9):3306-15. doi: 10.1210/jc.2016-1141. Epub 2016 Jun 14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bart Fauser, prof principal investigator
UMC Utrecht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases, run by UMC Utrecht at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
carotid intima media thickness (time frame: 10 years post diagnosis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02616510, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2018.