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

NCT05344547 | Completed

• 1 other identifier: 35179/1/22
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Disease

Outcome Measures

Primary Outcomes (1)

• Abnormal Cardiac Outcomes

  incidence of abnormal cardiac risk parameters among PCOS women who were apparently cardiac free women

  1 to 3 months

Study Arms (2)

PCOS Patient

Diagnostic Test: Cardiac risk ratio (CRR)

Non-PCOS Patient

Diagnostic Test: Cardiac risk ratio (CRR)

Interventions

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).

Non-PCOS Patient; PCOS Patient

Eligibility Criteria

• Age: 30 Years - 40 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta university

Tanta, El-Gharbyia, 13511, Egypt

Location

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of Cardiology

Study Record Dates

• First Submitted: April 16, 2022
• First Posted: April 25, 2022
• Study Start: March 21, 2020
• Primary Completion: August 15, 2021
• Study Completion: November 17, 2021
• Last Updated: April 25, 2022

Record last verified: 2022-04

Locations

EG (1)