Clinical trial NCT06794684: PRogression of Atheroma Evaluated by CT Angiography and IntraCoronary Imaging tEchniques
Official title: Evaluation of Atherosclerotic Plaque Progression by Coronary Computed Tomography Angiography and Intracoronary Imaging Techniques in Patients With Coronary Artery Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Arterial Disease (CAD)
Coronary Arteriosclerosis
Keywords: Coronary CTA
Plaque Progression
coronary artery disease
high-risk plaques
plaque composition
intracoronary imaging
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2025-01-27
Enrollment: 50000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This is a combination of retrospective and prospective cohort studies. Patients with clinical angina pectoris or suspected CAD who undergo coronary CTA scan, including outpatient and hospitalized patients, are consecutively enrolled.

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.

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

Primary outcomes:
measure: Changes in total atheroma volume (TAV)
timeFrame: 24 months
Secondary outcomes:
measure: Major cardiovascular events (MACEs)
timeFrame: 5 years
measure: Cardiovascular death
timeFrame: 5 years
measure: Myocardial infarction
timeFrame: 5 years
measure: Unplanned revascularization
timeFrame: 5 years
measure: Changes in calcified plaque volume
timeFrame: 24 months
measure: Changes in non-calcified plaque volume
timeFrame: 24 months
measure: Changes in fibrous plaque volume
timeFrame: 24 months
measure: Changes in fibrousfatty plaque volume
timeFrame: 24 months
measure: Changes in necrotic core volume
timeFrame: 24 months
measure: Changes in high-risk plaque (HRP) features
timeFrame: 24 months
measure: Changes in perivascular adipose tissue (PVAT) volume
timeFrame: 24 months
measure: Changes in perivascular adipose tissue (PVAT) density
timeFrame: 24 months
measure: Changes in perivascular adipose tissue (PVAT) distribution
timeFrame: 24 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: CAAC East China Aviation Personnel Medical Appraisal Center, Civil Aviation Shanghai Hospital
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Study officials:
affiliation: Ruijin Hospital
name: Ruiyan Zhang, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: