FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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

 


 
Close