PRogression of Atheroma Evaluated by CT Angiography and IntraCoronary Imaging tEchniques

NCT06794684 · tracked via the Priya Life Science China tracker

Sponsor

Ruijin Hospital

Phase

Observational

Started

2016-01-01

Last updated

2025-01-27

Condition(s) studied

Coronary Arterial Disease (CAD)Coronary Arteriosclerosis

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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 outcome measure(s)

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

Trial sites (2)

Facility	City	Region	Status
CAAC East China Aviation Personnel Medical Appraisal Center, Civil Aviation Shanghai Hospital	Shanghai	China	Recruiting
Ruijin Hospital, Shanghai Jiaotong University School of Medicine	Shanghai	China	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06794684 on ClinicalTrials.gov ↗ ← All trials in China