PRogression of Atheroma Evaluated by CT Angiography and IntraCoronary Imaging tEchniques

Recruiting

• Conditions: Coronary Arterial Disease (CAD); Coronary Arteriosclerosis

• Registration Number: NCT06794684
• Lead Sponsor: Ruijin Hospital

Brief Summary

This is a combined cohort study with retrospectively and prospectively enrolled coronary artery disease (CAD) patients. All the patients will undergo clinical follow-up for up to 5 years, and repeat coronary CTA will be conducted after 2 years. Comprehensive morphological and functional plaque analysis will be performed. The impact of these morphological and functional parameters, alongside cardiometabolic factors and pharmacological treatments on plaque progression and the occurrence of major adverse cardiovascular events (MACEs) will be analyzed. In addition, intracoronary imaging techniques will be used to improve the accuracy of plaque analysis by coronary CTA.

Detailed Description

This is a combined cohort study with retrospectively and prospectively enrolled patients. Subjects with CAD detected by coronary CTA are consecutively enrolled. All the patients will undergo clinical follow-up for up to 5 years. Repeat coronary CTA will be conducted after 2 years. For patients referred to invasive coronary angiography, intracoronary imaging techniques, such as intravascular ultrasound (IVUS), optical coherence tomography (OCT), and near infrared spectroscopy (NIRS) will be performed. For all the prospectively enrolled patients, plasma and serum blood samples will be collected.

The purpose of this study is to investigate the natural history of coronary atherosclerotic plaques in this population. Comprehensive morphological plaque analysis will be performed to evaluate total atheroma volume (TAV), percent atheroma volume (PAV), plaque composition, high risk plaque features, and characteristics of perivascular adipose tissue (PVAT). Functional analysis will also be conducted to calculate hemodynamic parameters such as wall shear stress (WSS), oscillatory shear index (OSI), relative residence time (RTT), transverse WSS (transWSS), axis plaque stress (APS), fractional flow reserve (FFR), and δFFR across lesions. The associations of these morphological and functional parameters with plaque progression and the onset of major adverse cardiovascular events (MACEs) will be analyzed. In addition, the impact of pharmacological treatments and the levels of cardiometabolic factors on coronary plaque progression will also be investigated.

In the subpopulation who also receive intracoronary imaging examinations, intracoronary imaging modalities will be used to refine the inner and outer vessel contours, improve the accuracy of plaque composition characterization, and aid in the discovery of novel high-risk plaque features by coronary CTA.

Study Timeline

• Study Start: 2016-01-01
• Status Verified: 2025-01
• Study First Submitted: 2025-01-14
• Study First Submitted QC: 2025-01-21
• Last Update Submitted: 2025-01-21
• Study First Posted: 2025-01-27
• Last Update Posted: 2025-01-27
• Primary Completion: 2027-05-31
• Study Completion: 2030-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50000

Inclusion Criteria

• Age ≥ 18 years
• Clinically significant angina pectoris, or suspected CAD
• Receive coronary CTA scan, with a visible plaque (defined as ≥25% diameter stenosis) in major coronary arteries.

Exclusion Criteria

• Unsuitable for coronary CTA (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 percutaneous coronary intervention (PCI) or 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 ml/min)
• Familial hypercholesterolemia
• Estimated survival ≤ 1 year
• Malignant tumor
• Pregnant or lactation, or have the intention to give birth within one year
• Poor coordinance, unable to follow-up

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in total atheroma volume (TAV)	24 months	changes in TAV in whole heart and in target lesions measured by coronary CTA and quantification analysis at baseline and during follow-up

Secondary Outcome Measures

Name	Time	Method
Changes in high-risk plaque (HRP) features	24 months	Changes in the number of HRP features in whole heart and in target lesions measured by coronary CTA at baseline and during follow-up.
Changes in perivascular adipose tissue (PVAT) density	24 months	Changes in the density of PVAT measured by coronary CTA and quantification analysis at baseline and during follow-up
Major cardiovascular events (MACEs)	5 years	A composite endpoint of cardiovascular death, non-fatal myocardial infarction, and unplanned revascularization during follow-up
Cardiovascular death	5 years	The occurrence of cardiovascular death during follow-up
Changes in calcified plaque volume	24 months	Changes in calcified plaque volume in whole heart and in target lesions measured by coronary CTA and quantification analysis at baseline and during follow-up
Changes in perivascular adipose tissue (PVAT) volume	24 months	Changes in the volume of PVAT measured by coronary CTA and quantification analysis at baseline and during follow-up
Myocardial infarction	5 years	The occurrence of myocardial infarction during follow-up
Unplanned revascularization	5 years	The occurrence of unplanned revascularization during follow-up
Changes in non-calcified plaque volume	24 months	Changes in non-calcified plaque volume in whole heart and in target lesions measured by coronary CTA and quantification analysis at baseline and during follow-up
Changes in fibrous plaque volume	24 months	Changes in fibrous plaque volume in whole heart and in target lesions measured by coronary CTA and quantification analysis at baseline and during follow-up
Changes in fibrousfatty plaque volume	24 months	Changes in fibrousfatty plaque volume in whole heart and in target lesions measured by coronary CTA and quantification analysis at baseline and during follow-up
Changes in necrotic core volume	24 months	Changes in plaque necrotic core volume in whole heart and in target lesions measured by coronary CTA and quantification analysis at baseline and during follow-up
Changes in perivascular adipose tissue (PVAT) distribution	24 months	Changes in the distribution of PVAT measured by coronary CTA and quantification analysis at baseline and during follow-up

Trial Locations

Locations (2)

CAAC East China Aviation Personnel Medical Appraisal Center, Civil Aviation Shanghai Hospital; 🇨🇳 Shanghai, China

Ruijin Hospital, Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, China