Relation Between AI-QCA and Cardiac PET

NCT ID: NCT06397820

Last Updated: 2025-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

168 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-01

Study Completion Date

2024-12-31

Brief Summary

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The aim of the study is to evaluate the clinical implications of artificial Intelligence (AI)-assisted quantitative coronary angiography (QCA) and positron emission tomography (PET)-derived myocardial blood flow in clinically indicated patients.

Detailed Description

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Percutaneous coronary angiography (CAG) is a standard method for evaluating coronary artery disease. Traditionally, a reduction in the luminal diameter of the coronary arteries by 50% or more during angiography has been considered a significant stenotic lesion. However, the assessment of coronary artery stenosis is usually based on visual estimation by the operator in daily routine clinical practice, which interferes with the objective evaluation.

Quantitative coronary angiography (QCA) has been developed to overcome this limitation. This technique involves the software-based analysis of coronary images obtained through CAG. The previous study showed that there was low concordance between the QCA and visual estimation of coronary artery stenosis (Kappa=0.63) and a reclassification rate of approximately 20%. Furthermore, visual assessments tended to overestimate the degree of coronary artery stenosis, particularly in complex lesions such as bifurcation lesions.

However, there are some limitations to adopting QCA in our daily routine practice. The QCA cannot analyze coronary images on-site and is not fully automated, requiring manual adjustments by humans. Recent advancements have led to the development of artificial intelligence (AI)-based QCA software, which achieves complete automation in the analysis process and provides real-time objective evaluations of coronary artery stenosis.

This study aims to examine the clinical significance of AI-QCA by assessing the correlation between the degree of coronary stenosis detected by AI-QCA and myocardial blood flow abnormalities observed in 13NH3-Ammonia PET scans in patients with coronary artery disease.

Conditions

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Coronary Artery Disease Coronary Artery Stenosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Positive for PET-derived indexes

Patients who had decreased stress myocardial blood flow (MBF) or relative flow ratio (RFR) on PET

Percutaneous coronary intervention (PCI)

Intervention Type DEVICE

Revascularization by percutaneous coronary intervention for vessels with decreased PET-derived flow indexes

Negative for PET-derived indexes

Patients who had preserved stress myocardial blood flow (MBF) or relative flow ratio (RFR) on PET

No interventions assigned to this group

Interventions

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Percutaneous coronary intervention (PCI)

Revascularization by percutaneous coronary intervention for vessels with decreased PET-derived flow indexes

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Subject must be ≥18 years
2. Patients suspected with CAD or ischemic heart disease
3. Patients undergoing CAG and cardiac PET for evaluation of severity of coronary artery disease

Exclusion Criteria

1. Poor imaging quality of CAG and PET which were not available for core-lab analysis
2. Chronic total occlusion
3. Time interval was more than \>3 months between CAG and PET
4. History of coronary artery bypass grafting
5. History of acute myocardial infarction or recent myocardial infarction
6. Heart failure (left ventricular ejection fraction \<40%)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chonnam National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Seung Hun Lee

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sang-Geon Cho, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Chonnam National University Hospital

Seung Hun Lee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Chonnam National University Hospital

Locations

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Chonnam National University Hospital

Gwangju, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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CNUH-AI-CARPET

Identifier Type: -

Identifier Source: org_study_id

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