CTRI/2025/08/093056Not yet recruitingNot Applicable
Evaluation of Cardiovascular Health Based on Life’s Essential 8 Metrics in Women with Polycystic Ovary Syndrome(PCOS)
Not provided1 site in 1 country224 target enrollmentStarted: August 25, 2025Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 224
- Locations
- 1
- Primary Endpoint
- LE 8 metrics score
Study Overview
Brief Summary
| Polycystic Ovarian syndrome (PCOS) is a heterogenous, chronic inflammatory disorder typically characterized by hyperandrogenism, chronic anovulation/oligo-ovulation, and polycystic ovarian morphology with a great deal of variation in symptoms and their severity.Although cardinal symptoms of this disease are menstrual irregularities, acne, hirsutism and infertility, it is associated with a lifetime risk of cardiovascular and metabolic diseases. Emerging data suggests that presence of obesity, insulin resistance and excess androgens predispose these women to an early risk of significant metabolic disturbances like, dyslipidaemia, hypertension and type 2 diabetes mellitus. The International Evidence based PCOS guidelines (2023) has recommended to do universal risk assessment for cardiovascular diseases in PCOS regardless of age and BMI. Much of the management in PCOS is typically focused on addressing current symptoms such as the ovulatory dysfunction and infertility, and not on the long-term risks conferred by PCOS, such as cardiovascular disease (CVD). AHA has published goals and metrics for cardiovascular health and proposed ‘Life’s Essential 8’ (LE8) cardiovascular health metrics to measure, monitor and modify an individual or population’s cardiac health. LE8 metric offers a comprehensive framework to evaluate cardiovascular health by integrating behavioral and clinical factors. Flow-mediated dilation (FMD) and arterial stiffness are non-invasive markers to assess cardiovascular health which reflect endothelial function and arterial elasticity, respectively.In this study we will evaluate the cardiovascular health of women with PCOS using the LE8 metrics .The results of this study will give an insight into the cardiometabolic health of women with PCOS and help us counsel our patients accordingly at diagnosis to prevent such long-term consequences of the syndrome through appropriate lifestyle modifications |
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 35.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Women diagnosed with PCOS by modified Rotterdam criteria.
Exclusion Criteria
- •1.Women with endocrine disorders such as Cushing’s Syndrome, acromegaly, pituitary adenoma, hypothyroidism.
- •2.Women with heart, renal or liver diseases.
- •3.Pregnant Women.
Outcomes
Primary Outcomes
LE 8 metrics score
Time Frame: at recruitment
Secondary Outcomes
- LE 8 metrics
- HOMA -IR
- Arterial Stiffness
- Endothelial Function(at recruitment)
Investigators
Dr Garima Kachhawa
All India Institute of Medical Sciences, New Delhi
Study Sites (1)
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