Women With Polycystic Ovary Syndrome Are at High Risk for Cardiac Insults

NCT ID: NCT05344547

Last Updated: 2022-04-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-03-21
• Study Completion Date: 2021-11-17

Brief 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 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

Conditions

Cardiac Disease

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

PCOS Patient

Cardiac risk ratio (CRR)

Intervention Type: 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).

Non-PCOS Patient

Cardiac risk ratio (CRR)

Intervention Type: 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).

Interventions

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).

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Exclusion Criteria

• 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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Amr Fayez Al-kassas

lecturer of Cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tanta university

Tanta, El-Gharbyia, Egypt

Countries

Egypt

Other Identifiers

35179/1/22

Identifier Type: -

Identifier Source: org_study_id