PRogression of Atheroma Evaluated by CT Angiography and IntraCoronary Imaging tEchniques
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Coronary Arterial Disease (CAD), Coronary Arteriosclerosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Atherosclerotic Plaque Progression by Coronary Computed Tomography Angiography and Intracoronary Imaging Techniques in Patients With Coronary Artery Disease
Overview
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.
Primary outcome measures
- Changes in total atheroma volume (TAV) [Time frame: 24 months]
Secondary outcome measures (12)
- Major cardiovascular events (MACEs) [Time frame: 5 years]
- Cardiovascular death [Time frame: 5 years]
- Myocardial infarction [Time frame: 5 years]
- Unplanned revascularization [Time frame: 5 years]
- Changes in calcified plaque volume [Time frame: 24 months]
- Changes in non-calcified plaque volume [Time frame: 24 months]
- Changes in fibrous plaque volume [Time frame: 24 months]
- Changes in fibrousfatty plaque volume [Time frame: 24 months]
- Changes in necrotic core volume [Time frame: 24 months]
- Changes in high-risk plaque (HRP) features [Time frame: 24 months]
- Changes in perivascular adipose tissue (PVAT) volume [Time frame: 24 months]
- Changes in perivascular adipose tissue (PVAT) density [Time frame: 24 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 2 centers
- CAAC East China Aviation Personnel Medical Appraisal Center, Civil Aviation Shanghai Hospi — Shanghai
- Ruijin Hospital, Shanghai Jiaotong University School of Medicine — Shanghai
Identifiers
NCT: NCT06794684 · RJH-PRACTICE