跳至主要内容
临床试验/CTRI/2026/01/100417
CTRI/2026/01/100417尚未招募不适用

To evaluate the diagnostic accuracy of artificial intelligence based coronary CT Software in Coronary Artery Disease

Siemens Healthcare Pvt. Ltd.1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2026年2月15日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
1,000
试验地点
1
主要终点
stratification by CAD-RADS

研究概览

简要总结

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 Dharand Dr Bharat Aggarwalat Max Super Speciality Hospital Saket withSiemens 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.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 85.00 Year(s)(—)
性别
All

入选标准

  • •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.

排除标准

  • •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.

结局指标

主要结局

stratification by CAD-RADS

时间窗: Baseline CADRAD score

Primary outcome is the diagnostic accuracy of AI software in coronary artery

时间窗: Baseline CADRAD score

disease, calcium scoring & characterisation and grading of plaque & stenosis and risk

时间窗: Baseline CADRAD score

次要结局

  • Secondary Outcome is to benchmark the present reporting system versus AI(software.)

研究者

发起方
Siemens Healthcare Pvt. Ltd.
申办方类型
Other [public multinational industrial technology company]
责任方
Principal Investigator
主要研究者

Dr Anandamoyee Dhar

Max Super Speciality Hospital, Saket (A unit of Max Healthcare Institute Limited)

研究点 (1)

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