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A study on the diagnostic accuracy of coronary CT angiography with different algorithms for fractional flow reserve

A study on the diagnostic accuracy of coronary CT angiography with different algorithms for fractional flow reserve

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600118075
Enrollment
Unknown
Registered
2026-02-02
Start date
2026-02-15
Completion date
Unknown
Last updated
2026-02-09

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

Conditions

Coronary atherosclerotic heart disease

Interventions

Gold Standard:Invasive Fractional Flow Reserve
Index test:Coronary Artery CT-FFR

Sponsors

Huzhou Center Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Patients aged 18 years or older with full civil capacity; 2.Clinically suspected of coronary heart disease and underwent coronary artery CT angiography (CCTA) at our hospital during the study period; 3.After a CCTA examination, an invasive coronary angiography (ICA) was performed for further diagnostic needs, and during the angiography, invasive FFR measurement was conducted on at least one coronary artery lesion. 4.The interval between CCTA and invasive FFR examinations is short (within 60 days), during which no coronary artery intervention (stent implantation or bypass surgery) has been received, and the condition has not changed significantly, to ensure that the results of the two examinations are comparable. 5.The patient's clinical data and imaging data are complete. Original CCTA images are available for reconstruction and analysis using different algorithms, and the invasive FFR results are complete and usable.

Exclusion criteria

Exclusion criteria: 1.The original CCTA image quality is poor and cannot meet the requirements for CT-FFR reconstruction analysis (such as images that are unevaluable due to severe arrhythmia, motion artifacts, or extremely severe calcification). 2.Cases where invasive FFR measurement failed or data was missing; 3.There are situations where the use of iodinated contrast agents is contraindicated during CCTA (such as a history of severe iodine allergy) or severe renal insufficiency (creatinine >= 120 µmol/L), which limits the application of contrast agents. Typically, such patients do not undergo CCTA, but if they do, they are not included. 4.When in an unstable condition such as acute coronary syndrome (e.g., during a myocardial infarction), or when complicated by congenital heart disease, or when image distortion occurs due to implanted devices such as pacemakers; 5.Patients who have previously undergone coronary stent implantation or coronary artery bypass grafting and whose target vessel evaluation is affected; 6.Other factors affecting the accuracy of the research (such as participants simultaneously participating in other clinical studies that may influence the results of this study). Participants meeting any exclusion criteria will not be included in this study.

Design outcomes

Primary

MeasureTime frame
The diagnostic accuracy of CT-FFR in determining functional stenosis (with invasive FFR = 0.80 as the criterion for myocardial ischemia);

Secondary

MeasureTime frame
The influence of patient-specific factors on CT-FFR;The impact of different reconstruction times on relative CT-FFR results;Differences in CT-FFR results from different algorithms;

Countries

China

Contacts

Public ContactDong Liu

Huzhou Center Hospital

187287090@qq.com+86 572 2555232

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 15, 2026