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CTRI Number  CTRI/2026/01/100417 [Registered on: 06/01/2026] Trial Registered Prospectively
Last Modified On: 06/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [AI validation study]  
Study Design  Single Arm Study 
Public Title of Study   Study to check how well an AI-based heart scan software can detect heart disease. 
Scientific Title of Study   To evaluate the diagnostic accuracy of artificial intelligence based coronary CT Software in Coronary Artery Disease 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anandamoyee Dhar 
Designation  Associate Director 
Affiliation  Max Super Speciality Hospital, Saket (A unit of Max Healthcare Institute Limited) 
Address  Department of Radiology Max Super Speciality Hospital Saket(West Block) 1 Press Enclave Road Saket New Delhi

South
DELHI
110017
India 
Phone  9810418279  
Fax    
Email  anandmoyee.dhar@maxhealthcare.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Bharat Aggarwal 
Designation  Principal Director, Radiology Services 
Affiliation  Max Super Speciality Hospital Saket (A unit of Max Healthcare Institute Limited) 
Address  Department of Radiology Max Super Speciality Hospital Saket(West Block) 1 Press Enclave Road Saket New Delhi

South
DELHI
110017
India 
Phone  9810077484  
Fax    
Email  bharat.aggarwal@maxhealthcare.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rajesh Saxena 
Designation  Vice President 
Affiliation  Max Super Speciality Hospital, Saket 
Address  Room 4, Service Floor, East Block, Office Of research Max Super Speciality Hospital Saket New Delhi

South
DELHI
110017
India 
Phone  9818474003  
Fax    
Email  rajesh.saxena@maxhealthcare.com  
 
Source of Monetary or Material Support  
Siemens Healthcare Pvt. Ltd. 
 
Primary Sponsor  
Name  Siemens Healthcare Pvt. Ltd. 
Address  9th Floor, Godrej One, Pirojshahnagar, Eastern Express Highway, Vikhroli East, Mumbai - 400079 
Type of Sponsor  Other [public multinational industrial technology company] 
 
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 Anandamoyee Dhar  Max Super Speciality Hospital, Saket  Room 5 Ground floor Department of Radiology Max Super Speciality Hospital (A unit of MHIL)West Block 1 Press Enclave Road Saket New Delhi
South
DELHI 
9810418279

anandmoyee.dhar@maxhealthcare.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Max Healthcare Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I249||Acute ischemic heart disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  CT Coronary for AI Validation  Diagnostic accuracy of artificial intelligence based software in CT coronary angiography in detection and characterisation of coronary artery disease, to determine the extent of disease and risk stratification of coronary artery disease by CAD-RADS. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  Retrospective analysis of 1000 consecutive cases
conducted in the Department of Radiology in Siemens machine with
complete data (Annonymised Computed Tomography Angiography Images
and reports) available on PACS will be included in the study.  
 
ExclusionCriteria 
Details  Cases which complete data is not available on PACS will be excluded.
CADRADS N studies with marked motion artefact due to respiratory artefact.
Patients with cardiac surgery, percutaneous coronary intervention,
bypass grafting.
Patients with coronary malformation or aneurysm.
Calcium score of more than 1000 H 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Primary outcome is the diagnostic accuracy of AI software in coronary artery
disease, calcium scoring & characterisation and grading of plaque & stenosis and risk
stratification by CAD-RADS 
Baseline CADRAD score 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary Outcome is to benchmark the present reporting system versus AI
software.  
Baseline CADRAD Score 
 
Target Sample Size   Total Sample Size="1000"
Sample Size from India="1000" 
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)   15/02/2026 
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="2"
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 - NO
Brief Summary  

The study titled - To evaluate the diagnostic accuracy of artificial intelligence-based coronary CT software in coronary artery disease is being conducted by Dr Anandamoyee Dhar and Dr Bharat Aggarwal at Max Super Speciality Hospital Saket with Siemens Healthcare Pvt Ltd as the sponsor. The aim of the study is to find out how accurately an AI-powered software can detect and describe blockages and other issues in heart arteries using Coronary CT Angiography (CCTA) when compared with human radiologists. Since heart diseases, especially coronary artery disease (CAD), are a leading cause of death worldwide, early and accurate detection plays a crucial role in preventing complications. The study uses data from 1,000 CT angiography scans performed between August 2020 and June 2025 at Max Hospital. It is a retrospective study, meaning that previously collected scan data will be analysed. The AI software will assess the calcium levels, type of plaque, degree of artery narrowing (stenosis), and assign a risk score using the CAD-RADS system, while its performance will be compared with that of expert radiologists. Only complete, good-quality scans done on Siemens machines will be included, and cases with incomplete data, heart surgeries, or very high calcium levels will be excluded. The study poses minimal risk to patients as it only uses anonymized records without personal identifiers, and no direct contact with patients will occur. Ethical approval is obtained from the institutional ethics committee, and patient confidentiality will be strictly maintained. The results will help determine whether AI can improve the speed and accuracy of diagnosing coronary artery disease and will be published in national and international medical journals.

 
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