Cardiac DiseaseNCT05344547
Women With Polycystic Ovary Syndrome Are at High Risk for Cardiac Insults
An observational study of Cardiac Disease, run by Tanta University at 1 site in Egypt.
Trial summary
Objectives: Evaluation of the cardiovascular (CV) risk in a sample of CV asymptomatic infertile women with polycystic ovary syndrome (PCOS). Patients \& Methods: 100 infertile PCOS women older than 30 years (PCOS group) and 50 fertile non-PCOS women (Non-PCOS group) underwent gynecological and laboratory diagnosis and… Read more about this study
- Who is it for?
- Ages 30 to 40 years, women only
- Conditions the study is for
- Cardiac Disease
- What is being tested?
- Cardiac risk ratio (CRR)
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Mar 2020to 17 Nov 2021
- 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 30 to 40 years
- Women only
- Adult
Study population: Women attending the infertility clinics at Tanta and Benha University Hospitals were eligible for evaluation for the PCOS as a cause of infertility. Gynecological evaluation entails data concerning present and past history of menstrual regularity, previous pregnancy for married women, previous investigations or therapies for PCOS or infertility. PCOS was diagnosed depending on the presence of at least two of the Rotterdam criteria
Who may be able to join
- Infertile PCOS women older than 30 years and free of exclusion criteria were enrolled in the study as PCOS group. Fifty non-PCOS women of age- and BMI cross-matched to the enrolled PCOS women with regular menstrual cycles or fertile if married were collected as control (Non-PCOS) group. Only women who signed the written informed consent will be enrolled in the study.
Who cannot join
- Age younger than 30 years old, BMI>35 kg/m2, presence of acute or chronic inflammatory diseases, diabetes mellitus, hyperprolactinemia, thyroid dysfunction, Cushing's syndrome, congenital adrenal hyperplasia, adrenal tumor or ovarian tumor, autoimmune disease, malignancy, central nervous system disease, current or previous use of oral contraceptives within 6 months of enrollment were excluded from the study. Patients had congenital cardiac lesions, manifestations of atherosclerosis or family history of cardiac or cerebrovascular insults, ejection fraction <50%, regional wall motion abnormalities and significant valvular diseases were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Women With Polycystic Ovary Syndrome Are at High Risk to Cardiac Insults
Objectives: Evaluation of the cardiovascular (CV) risk in a sample of CV asymptomatic infertile women with polycystic ovary syndrome (PCOS).
Patients \& Methods: 100 infertile PCOS women older than 30 years (PCOS group) and 50 fertile non-PCOS women (Non-PCOS group) underwent gynecological and laboratory diagnosis and then underwent a diagnostic protocol consisting of determination of body mass index (BMI), Homeostasis model assessment of insulin resistance (HOMA-IR) scoring and cardiologic evaluation using echocardiography, estimation of carotid artery intima-media thickness (CIMT), coronary artery calcium (CAC) score using multi-slice non-contrast cardiac CT and cardiac risk ratio (CRR). Study outcomes included the incidence of abnormal cardiac risk parameters and the determination of the best minimally invasive modality to be used as a screening test for these women.
Read the detailed description
Women attending the infertility clinics at Tanta and Benha University Hospitals were eligible for evaluation for PCOS as a cause of infertility. Gynecological evaluation entails data concerning present and past history of menstrual regularity, previous pregnancy for married women, previous investigations or therapies for PCOS or infertility. PCOS was diagnosed depending on the presence of at least two of the Rotterdam criteria
- Conditions
- Cardiac Disease
- Being tested
- Cardiac risk ratio (CRR)
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac risk ratio (CRR)Diagnostic test
Cardiac risk ratio (CRR) was calculated according to Genest et al. (23) as serum total cholesterol (TC) level divided by serum high-density lipoprotein-cholesterol (HDL-c) level and woman with CRR at ≥3.5 was considered at risk of cardiac disease (24).
| Study group | Role | What they receive |
|---|---|---|
| PCOS Patient | Not described Receives: Diagnostic Test: Cardiac risk ratio (CRR) | |
| Non-PCOS Patient | Not described Receives: Diagnostic Test: Cardiac risk ratio (CRR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abnormal Cardiac Outcomes
incidence of abnormal cardiac risk parameters among PCOS women who were apparently cardiac free women
Measured: 1 to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start21 Mar 2020
- Primary completion15 Aug 2021
- Study completion17 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac DiseaseStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe 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 only
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Fayez Al-kassas, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05344547
- Sponsor's protocol ID
- 35179/1/22
- Status last verified
- Apr 2022
- First submitted
- 16 Apr 2022
- Last updated
- 25 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Women With Polycystic Ovary Syndrome Are at High Risk to Cardiac Insults
- ClinicalTrials.gov ID
- NCT05344547
- Acronym / sponsor ID
- 35179/1/22
- Conditions
- Cardiac Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 21 Mar 2020 (actual)
- Primary completion
- 15 Aug 2021 (actual)
- Study completion
- 17 Nov 2021 (actual)
- First posted
- 25 Apr 2022 (actual)
- 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.
Objectives: Evaluation of the cardiovascular (CV) risk in a sample of CV asymptomatic infertile women with polycystic ovary syndrome (PCOS).
Patients \& Methods: 100 infertile PCOS women older than 30 years (PCOS group) and 50 fertile non-PCOS women (Non-PCOS group) underwent gynecological and laboratory diagnosis and then underwent a diagnostic protocol consisting of determination of body mass index (BMI), Homeostasis model assessment of insulin resistance (HOMA-IR) scoring and cardiologic evaluation using echocardiography, estimation of carotid artery intima-media thickness (CIMT), coronary artery calcium (CAC) score using multi-slice non-contrast cardiac CT and cardiac risk ratio (CRR). Study outcomes included the incidence of abnormal cardiac risk parameters and the determination of the best minimally invasive modality to be used as a screening test for these women.
Detailed description
Women attending the infertility clinics at Tanta and Benha University Hospitals were eligible for evaluation for PCOS as a cause of infertility. Gynecological evaluation entails data concerning present and past history of menstrual regularity, previous pregnancy for married women, previous investigations or therapies for PCOS or infertility. PCOS was diagnosed depending on the presence of at least two of the Rotterdam criteria
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCOS Patient | – | Diagnostic Test: Cardiac risk ratio (CRR) |
| Non-PCOS Patient | – | Diagnostic Test: Cardiac risk ratio (CRR) |
Who may qualify
- Ages
- 30 to 40 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Women attending the infertility clinics at Tanta and Benha University Hospitals were eligible for evaluation for the PCOS as a cause of infertility. Gynecological evaluation entails data concerning present and past history of menstrual regularity, previous pregnancy for married women, previous investigations or therapies for PCOS or infertility. PCOS was diagnosed depending on the presence of at least two of the Rotterdam criteria
Key inclusion criteria (1 listed)
- Infertile PCOS women older than 30 years and free of exclusion criteria were enrolled in the study as PCOS group. Fifty non-PCOS women of age- and BMI cross-matched to the enrolled PCOS women with regular menstrual cycles or fertile if married were collected as control (Non-PCOS) group. Only women who signed the written informed consent will be enrolled in the study.
Key exclusion criteria (1 listed)
- Age younger than 30 years old, BMI>35 kg/m2, presence of acute or chronic inflammatory diseases, diabetes mellitus, hyperprolactinemia, thyroid dysfunction, Cushing's syndrome, congenital adrenal hyperplasia, adrenal tumor or ovarian tumor, autoimmune disease, malignancy, central nervous system disease, current or previous use of oral contraceptives within 6 months of enrollment were excluded from the study. Patients had congenital cardiac lesions, manifestations of atherosclerosis or family history of cardiac or cerebrovascular insults, ejection fraction <50%, regional wall motion abnormalities and significant valvular diseases were excluded.
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 |
|---|---|---|
| Cardiac risk ratio (CRR)Cardiac risk ratio (CRR) was calculated according to Genest et al. (23) as serum total cholesterol (TC) level divided by serum high-density lipoprotein-cholesterol (HDL-c) level and woman with CRR at ≥3.5 was considered at risk of cardiac disease (24). | Diagnostic test | Non-PCOS Patient, PCOS Patient |
Primary outcome
Abnormal Cardiac Outcomes
Time frame: 1 to 3 months
incidence of abnormal cardiac risk parameters among PCOS women who were apparently cardiac free women
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 25 Apr 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cardiac Disease, run by Tanta University at 1 site in Egypt.
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 25 Apr 2022. 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 Egypt. 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?
Abnormal Cardiac Outcomes (time frame: 1 to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Apr 2022.