RecruitingACTRN12621001018808

The ARISTOCRAT Registry- The Australian natural history of pericoronary adipose tissue attenuation, radiomics and plaque by computed tomographic angiography

The Australian multi-centre registry for serial cardiac computed tomography angiography: A comprehensive exploration of the natural history of pericoronary adipose tissue attenuation and radiomics

Sponsor

Monash Cardiovascular Research Centre, Victorian Heart Institute and Monash University

Enrollment

300 participants

Start Date

Jul 28, 2021

Study Type

Observational

Conditions

Coronary atherosclerosis

Summary

CT coronary angiogram (CTCA) is increasingly used as a non-invasive imaging tool to assess the efficacy of novel therapies on coronary inflammation as well as plaque progression, and it is imperative that we understand the natural history of pericoronary adipose tissue (PCAT) inflammation on serial assessment. The ARISTOCRAT registry is a retrospective and prospective, open-label, multi-centre dynamic observational registry designed to directly assess the natural history of PCAT inflammation, coronary atherosclerosis, characteristics, and determinants of coronary plaque progression.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 80 Yearss

Plain Language Summary

Simplified for easier understanding

This study, called the ARISTOCRAT Registry, is tracking changes in inflammation around the coronary arteries — the blood vessels that supply the heart — over time using CT coronary angiography (CTCA). Researchers have discovered that the fat tissue surrounding the heart arteries (pericoronary adipose tissue, or PCAT) changes its density when there is inflammation nearby, and this change can be measured on a CT scan. Persistent coronary inflammation is linked to heart attacks and disease progression, but little is known about how PCAT inflammation evolves over time in real patients. This is an observational registry — participants are not assigned any new treatment. Instead, people who have already had a CTCA at their participating institution are invited to have a follow-up CTCA as part of the study. The scans will be analysed for changes in PCAT, plaque characteristics, and coronary anatomy. To be eligible, you must be 18 to 80 years old, have previously undergone a clinically indicated CTCA at the same institution, and be able to provide written consent. People with severe heart failure, prior bypass surgery or coronary stenting, atrial fibrillation, contrast allergy, or significantly impaired kidney function are not eligible. The study is run by Monash University.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Patients presenting for clinically indicated computed tomography coronary angiogram (CTCA) and had previously underwent CTCA more than 12 months prior are invited to participate in the ARISTOCRAT registry. Once consented, the serial CTCA scanning parameters (scanner, kVP, and reconstruction kernel) will be matched with the prior study. This registry will be conducted conducted for the next 5 years. We will also collect data regarding participants' traditional cardiovascular risk factors, treatment with lipid-lowering therapy, and fasting lipid profile at the baseline and the serial CTCA study. Patient demographic data and traditional cardiovascular risk factors will be determined from patient questionnaires collected by CT nursing staffs at the time of CCTA scans and by review of electronic medical records. Fasting lipid profile done within 60 days of the CTCA will be collected retrospectively from medical records. These data will be collected via a secured online database in a deidentified manner. No further follow-up will be performed after the CTCA scan.