FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/11/060100 [Registered on: 21/11/2023] Trial Registered Prospectively
Last Modified On: 21/01/2026
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Cardiovascular risk assessment in Spondyloarthritis patients 
Scientific Title of Study   Optimal strategy for Cardiovascular risk assessment in Spondyloarthritis : A comparative analysis between traditional cardiovascular risk score (QRISK3 score) versus traditional risk score supplemented with either Carotid ultrasound or Coronary CT angiography 
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 Joydeep Samanta 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences (AIIMS), Raipur 
Address  Dept of General Medicine, Ground Floor, D Block, Hospital Building, AIIMS Raipur, Tatibandh, Raipur

Raipur
CHHATTISGARH
492099
India 
Phone  9836594064  
Fax    
Email  samantajoydeep@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Joydeep Samanta 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences (AIIMS), Raipur 
Address  Dept of General Medicine, Ground Floor, D Block, Hospital Building, AIIMS Raipur, Tatibandh, Raipur

Raipur
CHHATTISGARH
492099
India 
Phone  9836594064  
Fax    
Email  samantajoydeep@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Joydeep Samanta 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences (AIIMS), Raipur 
Address  Dept of General Medicine, Ground Floor, D Block, Hospital Building, AIIMS Raipur, Tatibandh, Raipur

Raipur
CHHATTISGARH
492099
India 
Phone  9836594064  
Fax    
Email  samantajoydeep@yahoo.com  
 
Source of Monetary or Material Support  
Intramural Funding from AIIMS Raipur 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences (AIIMS), Raipur  
Address  Tatibandh, Raipur, Chhattisgarh, 492099 
Type of Sponsor  Government medical college 
 
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 Joydeep Samanta  AIIMS, Raipur  Dept. of General Medicine, D Block, Ground Floor, Hospital Building, AIIMS Raipur, Tatibandh, Raipur
Raipur
CHHATTISGARH 		 9836594064

samantajoydeep@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC-AIIMS Raipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M45-M49||Spondylopathies,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Newly diagnosed case/previously diagnosed case of axial Spondyloarthritis, Ankylosing Spondylitis, or Psoriatic Arthritis 
 
ExclusionCriteria 
Details  1. Pregnant women and lactating mother
2. Established cardiovascular diseases
3. History any cardiovascular or cerebrovascular events
4. History of any allergy to contrast agents
5. Presence of chronic kidney disease which is a contraindication for contrast use during CT scan
6. Any other contraindications for radiological investigations like CT or Ultrasound.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To compare the accuracy of Cardiovascular (CV) risk estimation in SpA patients by traditional CV risk prediction tool (QRISK3) alone versus traditional CV risk score (QRISK3) combined with either carotid US or coronary CT angiography  End of study period 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the cardiovascular (CV) risk estimation by QRISK3 combined with carotid US versus QRISK3 combined with coronary CT angiography in SpA patients for finding out the best tool for CV risk screening.  End of study period 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
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)   01/12/2023 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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   Inflammatory rheumatic diseases are traditionally considered a risk factor for cardiovascular diseases. However, EULAR has advocated the multiplication of cardiovascular risk-score estimated by traditional cardiovascular risk-scoring tools in patients of rheumatoid arthritis patients by a certain factor. There is no such advice for patients with spondyloarthritis. Besides, all the previous studies failed to identify any higher cardiovascular risk in patients with spondyloarthritis. There is a possibility that the traditional cardiovascular risk score may underestimate the actual cardiovascular risk in patients with spondyloarthritis. This current study is planned to see whether the traditional cardiovascular risk score used for the general population truly underestimates the cardiovascular risk in patients of spondyloarthritis and whether other strategies like carotid ultrasound and CT angiography fare better for cardiovascular risk assessment amongst the patients of spondyloarthritis. 
Close