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Impact of Artificial Intelligence–assisted CT Diagnosis on trEatment strategy in coronary artery Disease: a multicenter randomized clinical decision-making trial

Impact of Artificial Intelligence–assisted CT Diagnosis on trEatment strategy in coronary artery Disease: a multicenter randomized clinical decision-making trial

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600122871
Enrollment
Unknown
Registered
2026-04-20
Start date
2026-04-20
Completion date
Unknown
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary atherosclerosis with chest pain symptoms, with or without ischemia.

Interventions

Artificial intelligence–based automated diagnosis group:None
Junior radiologists’ manual diagnosis group:None
Junior radiologists combined with artificial intelligence–assisted diagnosis group:None

Sponsors

Shanghai General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Patients with an intermediate to high pretest probability of coronary artery disease (CAD), as determined by the modified Diamond–Forrester score. Pretest probability refers to the likelihood of having CAD prior to undergoing imaging examinations, and this score stratifies risk based on age, sex, and the nature of chest pain. 2.Underwent one-stop imaging with CT myocardial perfusion imaging (CT-MPI) and coronary CT angiography (CCTA). 3.Aged 18 years or older.

Exclusion criteria

Exclusion criteria: 1.Prior treatment for coronary artery disease (CAD), including stent implantation and revascularization. 2.Concomitant valvular disease, cardiomyopathy, or other cardiac conditions. 3.Poor image quality (Linker image quality score < 3 on the 5-point scale). 4.Failure of artificial intelligence (AI) software processing.

Design outcomes

Primary

MeasureTime frame
Rate of changes in treatment strategies across groups;

Secondary

MeasureTime frame
Proportion of cases involving the use of invasive coronary angiography among those with changes in treatment strategy across groups;Processing time required for each group;Diagnostic performance metrics of each imaging parameter across groups, including accuracy, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV).;

Countries

China

Contacts

Public ContactJiayin Zhang

Shanghai General Hospital

andrewssmu@msn.com+86 18930173280

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 1, 2026