| CTRI Number |
CTRI/2025/08/093056 [Registered on: 14/08/2025] Trial Registered Prospectively |
| Last Modified On: |
13/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
To screen for heart related risk factors based on Life’s Essential-8 metrics in women with Polycystic Ovarian Syndrome |
|
Scientific Title of Study
|
Evaluation of Cardiovascular Health Based on Life’s Essential 8 Metrics in Women with Polycystic Ovary Syndrome(PCOS) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Garima Kachhawa |
| Designation |
PROFESSOR |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room 701,7th floor,Mother and Child Block,Gate 6B, AIIMS, New Delhi
South DELHI 110029 India |
| Phone |
9868246702 |
| Fax |
911126588641 |
| Email |
garimakachhawa2012@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Garima Kachhawa |
| Designation |
PROFESSOR |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room 701,7th floor,Mother and Child Block,Gate 6B, AIIMS, New Delhi
South DELHI 110029 India |
| Phone |
9868246702 |
| Fax |
911126588641 |
| Email |
garimakachhawa2012@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Aklanta Bhattacharjya |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room 701,7th floor,Mother and Child Block,Gate 6B, AIIMS, New Delhi
Department of Obstetrics and Gynaecology
South
DELHI
110029
India
South DELHI 110049 India |
| Phone |
8638473073 |
| Fax |
|
| Email |
abhattacharjya1@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS, Ansari Nagar,New Delhi-110029 |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Garima Kachhawa |
AIIMS, New Delhi |
Room 701,7th floor,Mother and Child Block,Gate 6B, AIIMS, New Delhi South DELHI |
9868246702 911126588641 garimakachhawa2012@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy age and BMI matched reproductive women |
| Patients |
(1) ICD-10 Condition: E282||Polycystic ovarian syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Women diagnosed with PCOS by modified Rotterdam criteria |
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| LE 8 metrics score |
at recruitment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
LE 8 metrics
|
at recruitment |
HOMA -IR
|
at recruitment |
Arterial Stiffness
|
at recruitment |
| Endothelial Function |
at recruitment |
|
|
Target Sample Size
|
Total Sample Size="224" Sample Size from India="224"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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 | |