Risk Evaluation by COronary Imaging and Artificial intelliGence Based fuNctIonal analyZing tEchniques - III
Recruiting now
Conditions studied: Coronary Artery Disease, Coronary Atheroscleroses, Acute Coronary Syndromes (ACS)
In brief
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.
Key facts
- Study ID
- NCT06793774
- Run by
- Ruijin Hospital
- People needed
- 300
- Starts
- 2024-07-01
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2025-01-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Ruijin Hospital, Shanghai Jiaotong University School of Medicine — Shanghai, Shanghai Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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