| 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
|
|
|
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
|
|
|
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. |