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Completed

NCT Number: NCT06397820

Relation Between AI-QCA and Cardiac PET

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chonnam National University Hospital

Gwangju, 61469, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Percutaneous coronary intervention (PCI)

Device

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

Primary outcomes

  1. Correlation between diameter stenosis by AI-QCA and PET-driven RFR

    Time frame: Immediate after AI-QCA and PET exams

    Performance of AI-QCA predicting for PET-driven RFR

  2. Correlation between diameter stenosis by AI-QCA and PET-driven stress MBF

    Time frame: Immediate after AI-QCA and PET exams

    Performance of AI-QCA predicting for PET-driven stress MBF

Secondary outcomes

  1. Correlation between diameter stenosis by AI-QCA and PET-driven coronary flow reserve (CFR)

    Time frame: Immediate after AI-QCA and PET exams

    Performance of AI-QCA predicting for PET-driven CFR

  2. Correlation between diameter stenosis by AI-QCA and PET-driven coronary flow capacity (CFC)

    Time frame: Immediate after AI-QCA and PET exams

    Performance of AI-QCA predicting for PET-driven CFC

  3. Correlation between diameter stenosis by AI-QCA and PET-driven semi-quantitative markers of ischemia

    Time frame: Immediate after AI-QCA and PET exams

    Performance of AI-QCA predicting for PET-driven semi-quantitative markers of ischemia

  4. All-cause death

    Time frame: 1 year after last patient enrollment

    All-cause death

  5. Cardiovascular death

    Time frame: 1 year after last patient enrollment

    Cardiovascular death

  6. Myocardial infarction

    Time frame: 1 year after last patient enrollment

    Any myocardial infarction, defined by Forth Universal definition of myocardial infarction

  7. Rate of target lesion revascularization

    Time frame: 1 year after last patient enrollment

    Target lesion revascularization

  8. Rate of target vessel revascularization

    Time frame: 1 year after last patient enrollment

    Target vessel revascularization

  9. Rate of any revascularization

    Time frame: 1 year after last patient enrollment

    Any revascularization

  10. Rate of stent thrombosis

    Time frame: 1 year after last patient enrollment

    Definite or probable stent thrombosis, defined by ARC II definition

  11. Rate of cerebrovascular accident

    Time frame: 1 year after last patient enrollment

    Cerebrovascular accident

  12. Major adverse cerebrocardiovascular event (MACCE)

    Time frame: 1 year after last patient enrollment

    A composite of death, myocardial infarction, any revascularization, and cerebrovascular accident

Sponsors and collaborators

Lead sponsor

Chonnam National University Hospital

Other

Registry information

Official study title

Relation Between Artificial Intelligence (AI)-Assisted Quantitative Coronary Angiography and Positron Emission Tomography-Derived Myocardial Blood Flow

Acronym: AI-CARPET

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
May 3, 2024
Registry last updated
Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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