A CCTA Image Assisted Triage Software for the Assessment of Patients With Suspected Coronary Artery Disease

Coronary Heart Disease Clinical Trial

Official title:

A CCTA Image Assisted Triage Software for the Assessment of Patients With Suspected Coronary Artery Disease: a Retrospective, Multi-center, Blind-evaluation Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06172985
• Other study ID #: CT-091-2022
• Status: Active, not recruiting
• Start date: May 9, 2023
• Est. completion date: February 29, 2024

Study information

• Verified date: August 2023
• Source: Keya Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this clinical trail is to evaluate the effectiveness and accuracy of the CCTA image assisted triage software(DeepVessel® Cardisight, Keya Medical.) for the triage of patients with suspected coronary artery disease.

Description:

The CCTA images collected by each center within a certain period of time would be screened, desensitized, and then evaluated by the software and independent expert group respectively, to evaluate the effectiveness and accuracy of the coronary CT angiography image stenosis assisted triage software developed by Koyal Medical Technology Co. Experiment group: Evaluated by the software Independent expert group: Evaluated by experts (≥5 years of CCTA experience required)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1093
• Est. completion date: February 29, 2024
• Est. primary completion date: June 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. CCTA images acquired by CT detectors need to meet the following requirements:

• Check Modal = CT
• Number of detector rows = 64 rows
• Layer thickness =1mm
• Layer spacing =1mm
• Pixel pitch = 0.5mm
• Ball tube voltage = 70kV
• Number of layers = 100 layers

2. CCTA image quality score = 3 (5-point Likert scale).

Exclusion Criteria:

1. Severe coronary artery calcification, which in the judgment of readers affects the stenosis adjudicator;

2. Previous percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG);

3. Congenital anomalies of coronary artery origin or other malformations;

4. Coronary artery occlusive lesions;

5. Implantation of the pacemaker, internal defibrillator electrode, or prosthetic heart valve.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Other:
• No intervention
Due to observational study

Locations

Country	Name	City	State
China	Fuwai Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing
China	The Pearl River Hospital of Southern Medical University	Guangzhou	Guangdong
China	Huanggang Central Hospital	Huanggang	Hubei
China	The First Affiliated Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	Affiliated Hospital of Zunyi Medical University	Zunyi	Guizhou

Sponsors (1)

Lead Sponsor	Collaborator
Keya Medical

Country where clinical trial is conducted

China, 

References & Publications (5)

Choi AD, Marques H, Kumar V, Griffin WF, Rahban H, Karlsberg RP, Zeman RK, Katz RJ, Earls JP. CT Evaluation by Artificial Intelligence for Atherosclerosis, Stenosis and Vascular Morphology (CLARIFY): A Multi-center, international study. J Cardiovasc Compu — View Citation

Lucke C, Foldyna B, Andres C, Boehmer-Lasthaus S, Grothoff M, Nitzsche S, Gutberlet M, Lehmkuhl L. Post-processing in cardiovascular computed tomography: performance of a client server solution versus a stand-alone solution. Rofo. 2014 Dec;186(12):1111-21 — View Citation

Meijboom WB, Meijs MF, Schuijf JD, Cramer MJ, Mollet NR, van Mieghem CA, Nieman K, van Werkhoven JM, Pundziute G, Weustink AC, de Vos AM, Pugliese F, Rensing B, Jukema JW, Bax JJ, Prokop M, Doevendans PA, Hunink MG, Krestin GP, de Feyter PJ. Diagnostic ac — View Citation

Meyer M, Schoepf UJ, Fink C, Goldenberg R, Apfaltrer P, Gruettner J, Vajcs D, Schoenberg SO, Henzler T. Diagnostic performance evaluation of a computer-aided simple triage system for coronary CT angiography in patients with intermediate risk for acute cor — View Citation

Paul JF, Rohnean A, Giroussens H, Pressat-Laffouilhere T, Wong T. Evaluation of a deep learning model on coronary CT angiography for automatic stenosis detection. Diagn Interv Imaging. 2022 Jun;103(6):316-323. doi: 10.1016/j.diii.2022.01.004. Epub 2022 Ja — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Device Defects	In the course of clinical trials, there are unreasonable risks that may endanger human health and life safety under normal use of medical devices, such as label errors, quality problems, and frequent failures	October 13,2022 to March 1,2023
Primary	Sensitivity and specificity of experiment group in triage for patients with suspected coronary artery disease	Based on the results of the independent expert group, uses stenosis degree=50% as the boundary for triage indication on a per-patient basis.	October 13,2022 to March 1,2023
Secondary	Diagnostic time	Independent expert group: recording the sum of image post-processing time (T1) and the time to produce the results (T2); Experimental group: recording the time from image post-processing to outputting results; Calculate the difference between the two groups.	October 13,2022 to March 1,2023
Secondary	Patient as research unit	Evaluation criteria were established based on the results of the independent expert group to evaluate the total conformity rate, KAPPA value, positive predictive value (PPV) and negative predictive value (NPV) of triage tips for patients with suspected coronary heart disease in the experimental group.	October 13,2022 to March 1,2023
Secondary	Blood vessels were used as the research unit	Evaluation criteria were established based on the results of the independent expert group to evaluate the total conformity rate, KAPPA value, positive predictive value (PPV) and negative predictive value (NPV) of triage tips for patients with suspected coronary heart disease in the experimental group.	October 13,2022 to March 1,2023
Secondary	The vascular segment was used as the research unit	Evaluation criteria were established based on the results of the independent expert group to evaluate the total conformity rate, KAPPA value, positive predictive value (PPV) and negative predictive value (NPV) of triage tips for patients with suspected coronary heart disease in the experimental group.	October 13,2022 to March 1,2023
Secondary	Gender stratified statistics, respectively, with patients and blood vessels as research units	Evaluation criteria were established based on the results of the independent expert group to evaluate the sensitivity and specificity of the trial group to the triage hints of suspected patients with coronary heart disease	October 13,2022 to March 1,2023
Secondary	Manufacturer stratified statistics, respectively, with patients and blood vessels as research units	Evaluation criteria were established based on the results of the independent expert group to evaluate the sensitivity and specificity of the trial group to the triage hints of suspected patients with coronary heart disease	October 13,2022 to March 1,2023
Secondary	Row number stratified statistics, respectively, with patients and blood vessels as research units	Evaluation criteria were established based on the results of the independent expert group to evaluate the sensitivity and specificity of the trial group to the triage hints of suspected patients with coronary heart disease	October 13,2022 to March 1,2023
Secondary	The stratified statistics of tube voltage were conducted with patients and blood vessels as research units	Evaluation criteria were established based on the results of the independent expert group to evaluate the sensitivity and specificity of the trial group to the triage hints of suspected patients with coronary heart disease	October 13,2022 to March 1,2023
Secondary	Layer thickness stratified statistics, patients and blood vessels were used as research units	Evaluation criteria were established based on the results of the independent expert group to evaluate the sensitivity and specificity of the trial group to the triage hints of suspected patients with coronary heart disease	October 13,2022 to March 1,2023
Secondary	The patients and blood vessels were selected as the research units	Evaluation criteria were established based on the results of the independent expert group to evaluate the sensitivity and specificity of the trial group to the triage hints of suspected patients with coronary heart disease	October 13,2022 to March 1,2023
Secondary	Post-processing image quality evaluation	Calculate the percentage of post-processing images with the image quality score of 2 or above in the total post-processing images, and the difference between the independent expert group and experimental group.	October 13,2022 to March 1,2023
Secondary	Software performance evaluation	From the function of use, ease of operation, stability to evaluate, divided into satisfactory, general, unsatisfactory three levels.	October 13,2022 to March 1,2023

External Links

•   Guerbet. Xenetix® 350: Comparative Assessment of Image Quality for Coronary CT Angiography (X-ACT)[EB/OL]