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

Sponsor
Tanta University (Other)
Overall Status
Completed
CT.gov ID
NCT05344547
Collaborator
(none)
150
1
19.9
7.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Cardiac risk ratio (CRR)

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

Study Type:
Observational
Actual Enrollment :
150 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Women With Polycystic Ovary Syndrome Are at High Risk to Cardiac Insults
Actual Study Start Date :
Mar 21, 2020
Actual Primary Completion Date :
Aug 15, 2021
Actual Study Completion Date :
Nov 17, 2021

Arms and Interventions

Arm Intervention/Treatment
PCOS Patient

Diagnostic Test: 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).

Non-PCOS Patient

Diagnostic Test: 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).

Outcome Measures

Primary Outcome Measures

  1. Abnormal Cardiac Outcomes [1 to 3 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 40 Years
Sexes Eligible for Study:
Female
Inclusion Criteria:

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.

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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tanta university Tanta El-Gharbyia Egypt 13511

Sponsors and Collaborators

  • Tanta University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Amr Fayez Al-kassas, lecturer of Cardiology, Tanta University
ClinicalTrials.gov Identifier:
NCT05344547
Other Study ID Numbers:
  • 35179/1/22
First Posted:
Apr 25, 2022
Last Update Posted:
Apr 25, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 25, 2022