PRogression of Atheroma Evaluated by CT Angiography and IntraCoronary Imaging tEchniques
NCT ID: NCT06794684
Last Updated: 2025-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
50000 participants
OBSERVATIONAL
2016-01-01
2030-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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PRACTICE cohort
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Ruijin Hospital
OTHER
Responsible Party
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RUIYAN ZHANG
Professor
Principal Investigators
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Ruiyan Zhang, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Ruijin Hospital
Locations
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CAAC East China Aviation Personnel Medical Appraisal Center, Civil Aviation Shanghai Hospital
Shanghai, , China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RJH-PRACTICE
Identifier Type: -
Identifier Source: org_study_id
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