Risk Evaluation by COronary Imaging and Artificial intelliGence Based fuNctIonal analyZing tEchniques - III (RECOGNIZE-III)

Risk Evaluation by Coronary Imaging and Artificial Intelligence-Based Functional Analyzing Techniques: Integrated Plaque Analysis by Coronary CT Angiography and Intracoronary Imaging.

This is a single-center, prospective cohort study. This study is designed to accurately analyze coronary artery plaque characteristics and local hemodynamic parameters in patients diagnosed with chronic coronary syndrome (CCS) or non-ST-segment elevation acute coronary syndrome (NSTE-ACS), with marginal lesions or obstructive lesions in major coronary arteries by multimodality imaging including noninvasive coronary CT angiography (CCTA) and intracoronary imaging techniques, such as intravascular ultrasound (IVUS), optical coherence tomography (OCT), and near infrared spectroscopy (NIRS). The purpose of this study is to improve the accuracy and depth of plaque analysis by CCTA under the guidance of intracoronary imaging, therefore constructing a new CCTA-based high-risk plaque model.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Acute Coronary Syndromes (ACS); Coronary Atheroscleroses

Detailed Description

This is a single-center, prospective cohort study. This study is designed to accurately analyze coronary artery plaque characteristics and local hemodynamic parameters in patients diagnosed with chronic coronary syndrome (CCS) or non-ST-segment elevation acute coronary syndrome (NSTE-ACS), with marginal lesions (diameter stenosis [DS] between 40%-69%) or obstructive lesions (DS ≥70% or CT-FFR <0.8) in major coronary arteries by multimodality imaging including noninvasive coronary CT angiography (CCTA) and intracoronary imaging techniques, such as intravascular ultrasound (IVUS), optical coherence tomography (OCT), and near infrared spectroscopy (NIRS). The congruity and incongruity between different imaging modalities will be evaluated.

The purpose of this study is to improve the accuracy and depth of plaque analysis by CCTA under the guidance of intracoronary imaging by co-registration, feature extraction, radiomic analysis and machine learning. Afterwards, a new CCTA-based high-risk plaque model will be constructed through the training process guided by intracoronary imaging and hemodynamic evaluation.

The cohort will be followed-up every 3 months for 2 years. Cross-validation will be performed to compare the new model with traditional CTA models in detecting high-risk plaques and predicting the occurrence of major adverse cardiovascular events (MACEs). All the patients with CCS or NSTE-ACS, who undergo CCTA to confirm the presence of marginal or obstructive coronary lesions, and the subsequent invasive coronary angiography and intracoronary imaging examination within 1 month after CCTA will be enrolled.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Xiaoqun Wang, M.D., Ph.D.; Phone Number: 671605 +86 21 64370045; Email: xiaoqun_wang@hotmail.com
• Study Contact Backup: Name: Shuo Feng, M.D., Ph.D.; Phone Number: 671605 +86 21 64370045; Email: fengshuorv@hotmail.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Recruiting
      • Ruijin Hospital, Shanghai Jiaotong University School of Medicine
      • Contact: Jian Li, BS; Phone Number: 0086 021 64370045; Email: ruijincrc@126.com
      • Principal Investigator: Ruiyan Zhang, M.D., Ph.D.
      • Sub-Investigator: Xiaoqun Wang, M.D., Ph.D.
      • Sub-Investigator: Shuo Feng, M.D.,Ph,D,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

This cohort includes patients with coronary artery disease as detected by computed tomography angiography (CCTA), and was planned to receive coronary angiography.

Description

Inclusion Criteria:

• Age ≥ 18 years
• Patients with CCS or NSTE-ACS
• Receive CCTA scan, with marginal lesions (DS between 40%-69%) or obstructive lesions (DS ≥70% or CT-FFR <0.8) in major coronary arteries
• Receive invasive coronary angiography and intracoronary imaging examination, including IVUS, OCT, NIRS, within 1 month after CCTA

Exclusion Criteria:

• Unsuitable for CCTA (such as severe renal impairment, uncontrolled thyroid condition, allergic to iodine, etc.)
• Receive percutaneous coronary intervention (PCI) within 6 months
• Prior history of myocardial infarction or heart failure
• Prior history of coronary artery bypass graft (CABG)
• Abnormal liver function (serum alanine aminotransferase [ALT] level exceeding 3 times the upper limit of normal) or abnormal kidney function (eGFR ≤30%)
• Familial hypercholesterolemia
• Estimated survival ≤ 1 year
• Malignant tumor
• Pregnant or lactation, or have the intention to give birth within one year
• Poor compliance, unable to follow-up

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Study cohort; Patients with CCS or NSTE-ACS, who receive CCTA scan showing marginal or obstructive lesions (DS 40%-90%), are then referred to invasive coronary angiography with intracoronary imaging examination, such as IVUS, OCT, NIRS, within 1 month

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prediction performance of high-risk plaques by CCTA	By using intracoronary imaging as the 'gold standard', the new CCTA model generated by machine learning will be compared with traditional CCTA models in the prediction performance of high-risk plaques (area under receiver operating characteristics curve, etc.)	2 Years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major cardiovascular events (MACEs)	A composite endpoint of cardiovascular death, non-fatal myocardial infarction, and unplanned revascularization during follow-up. The prediction performance of MACEs by the new model and traditional CCTA models will be compared	2 years
Cardiovascular death	The occurrence of cardiovascular death during follow-up. The prediction performance of cardiovascular death by the new model and traditional CCTA models will be compared.	2 years
Myocardial infarction	The occurrence of myocardial infarction during follow-up. The prediction performance of myocardial infarction by the new model and traditional CCTA models will be compared.	2 years
Unplanned revascularization	The occurrence of unplanned revascularization during follow-up. The prediction performance of unplanned revascularization by the new model and traditional CCTA models will be compared.	2 years

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Investigators: Study Director: Ruiyan Zhang, M.D., Ph.D., Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: January 21, 2025
• First Submitted That Met QC Criteria: January 21, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 21, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: coronary CT angiography; intracoronary imaging; coronary optical coherence tomography
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Atherosclerosis; Acute Coronary Syndrome
• Other Study ID Numbers: 2022YFC2533502-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No