Relation Between AI-QCA and Cardiac PET

NCT06397820 | Completed DMC

• 1 other identifier: CNUH-AI-CARPET
• Study Type: observational
• Target: 168
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease; Coronary Artery Stenosis

Keywords

Invasive coronary angiography; Cardaic positron Emission Tomography; Artificial Intelligence; Quantitative Coronary Angiography

Outcome Measures

Primary Outcomes (2)

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

  Performance of AI-QCA predicting for PET-driven RFR

  Immediate after AI-QCA and PET exams

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

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

  Immediate after AI-QCA and PET exams

Secondary Outcomes (12)

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

  Immediate after AI-QCA and PET exams

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

  Immediate after AI-QCA and PET exams

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

  Immediate after AI-QCA and PET exams

• All-cause death

  1 year after last patient enrollment

• Cardiovascular death

  1 year after last patient enrollment

Study Arms (2)

Positive for PET-derived indexes

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

Device: Percutaneous coronary intervention (PCI)

Negative for PET-derived indexes

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

Interventions

Percutaneous coronary intervention (PCI) DEVICE

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

Positive for PET-derived indexes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with suspected coronary artery disease (CAD) undergoing invasive coronary angiography (CAG) and clinically indicated for cardiac PET assessment.

You may qualify if:

• 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

You may not qualify if:

• 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%)

Sponsors & Collaborators

• Chonnam National University Hospital: lead

Study Sites (1)

Chonnam National University Hospital

Gwangju, 61469, South Korea

Location

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Stenosis

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Sang-Geon Cho, MD, PhD

  Chonnam National University Hospital

  PRINCIPAL INVESTIGATOR

• Seung Hun Lee, MD, PhD

  Chonnam National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 3, 2024
• Study Start: September 1, 2021
• Primary Completion: July 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: After publication of main paper.
• Access Criteria: Executive Committee will discuss to share the de-identified data upon reasonable requests.

Locations

KR (1)