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CTRI Number  CTRI/2024/04/065707 [Registered on: 15/04/2024] Trial Registered Prospectively
Last Modified On: 10/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   To Stratify and Identify High Cardiovascular Risk in Rheumatoid Arthritis Patients. 
Scientific Title of Study   Cardiovascular Risk Stratification of Patients with Rheumatoid Arthritis 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Arborki Suiam 
Designation  Doctor (Post Graduate) 
Affiliation  Maulana Azad Medical College 
Address  Department Of Medicine,First Floor,B.L Taneja Block,Maulana Azad Medical College Aand Associated Hospitals.

Central
DELHI
110002
India 
Phone  9612286822  
Fax    
Email  arborsuiam@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sumeet Singla 
Designation  Professor 
Affiliation  Maulana Azad Medical College  
Address  Department Of Medicine,First Floor,B.L Taneja Block,Maulana Azad Medical College and Associated Hospitals.

Central
DELHI
110002
India 
Phone  9810104431  
Fax    
Email  sumeetsingla555@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sumeet Singla 
Designation  Professor 
Affiliation  Maulana Azad Medical College  
Address  Department Of Medicine,First Floor,B.L Taneja Block,Maulana Azad Medical College and Associated Hospitals.

Central
DELHI
110002
India 
Phone  9810104431  
Fax    
Email  sumeetsingla555@gmail.com  
 
Source of Monetary or Material Support  
DEPARTMENT OF MEDICINE,FIRST FLOOR,B.L TANEJA BLOCK MAULANA AZAD MEDICAL COLLEGE AND ASSOCIATED HOSPITALS,DELHI 110002 
 
Primary Sponsor  
Name  Maulana Azad Medical College 
Address  Department Of Medicine,First Floor,B.L Taneja Block Maulana Azzad Medical College and Associated Hospitals 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
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 Arborki Suiam  Maulana Azad Medical College and Lok Nayak Hospital  Rheumatology Clinics Of Department Of Medicine,4th Floor OPD Building Lok Nayak Hospital
Central
DELHI 		 9612286822

arborsuiam@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MAULANA AZAD MEDICAL COLLEGE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M059||Rheumatoid arthritis with rheumatoid factor, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  All adult patients above 18 years with Rheumatoid Arthritis according to the 2010 ACR/EULAR criteria. 
 
ExclusionCriteria 
Details  1.Rheumatoid Arthritis patients with manifest CVD such as Angina,Myocardial Infarction,Stroke,Peripheral Vascular Disease,Gangrene,Heart Failure(or those who have undergone Percutameous Transluminal Coronary Angioplasty and/or coronary Artery Bypass Graft)
2.Known case of diabetes mellitus and chronic kidney disease(eGFR <60ml/min/1.73m2)
3.Smoking
4.Patient taking statins
5.Overlap with other connective tissue disease. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.To stratify and identify high cardiovascular risk in Rheumatoid Arthritis using ASCVD score,QRISK-3 Score,FRS-CVD Score and ERS-RA Score.
2.To compare performance of each score with gold standard CIMT and/or Carotid Plaque in identifying high cardiovascular risk among patients of Rheumatoid Arthritis. 		 Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
1.Whether any combination(s) or EULAR modification of these risk scores can improve the sensitivity and accuracy to detect Rheumatoid Arthritis patients at high risk of Cardiovascular Disease.
2.Whether simple indices each such as Total cholesterol/HDL (Atherogenic ratio) ,hsCRP and ApoB/ApoA1 ratio can detect Rheumatoid Arthritis patients at high risk of cardiovascular disease. 		 Baseline 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   22/04/2024 
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="0"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [arborsuiam@gmail.com].

  6. For how long will this data be available start date provided 01-01-2025 and end date provided 01-01-2027?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Rheumatoid Arthritis is a systemic inflammatory disease affecting multiple system including cardiovascular system and CVD risk increase by two to three-folds in RA patients which increase mortality in these patients. Different scoring systems are used to assess the CVD risk which have been developed and validated in US,UK and Europe. However there is no studies from India that attempted CVD risk stratification in RA patients and its not clear whether those existing scores works optimal in Indian population. Thus there is a need for assessment and development of scoring system for Indian population.    
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