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

ConditionsCoronary Artery DiseaseCoronary AtherosclerosesAcute Coronary Syndromes (ACS)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRuijin Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

300 Participants
are grouped into 1 trial group
Group A: Study cohort

Trial outcomes

Primary outcomes

1

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.)

Time frame
2 Years

Secondary outcomes

1

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

Time frame
2 years
2

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.

Time frame
2 years
3

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.

Time frame
2 years
4

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.

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ruijin Hospital

Lead sponsor

Source ClinicalTrials.gov
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