PRogression of Atheroma Evaluated by CT Angiography and IntraCoronary Imaging tEchniques (PRACTICE)

January 21, 2025 updated by: RUIYAN ZHANG, Ruijin Hospital

Evaluation of Atherosclerotic Plaque Progression by Coronary Computed Tomography Angiography and Intracoronary Imaging Techniques in Patients With Coronary Artery Disease

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

50000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Shanghai, China, 200025
        • Recruiting
        • Ruijin Hospital, Shanghai Jiaotong University School of Medicine
        • Contact:
        • Contact:
        • Principal Investigator:
          • Xiaoqun Wang, M.D., Ph.D.
        • Sub-Investigator:
          • Shuo Feng, M.D., Ph.D.
      • Shanghai, China, 200000
        • Recruiting
        • CAAC East China Aviation Personnel Medical Appraisal Center, Civil Aviation Shanghai Hospital
        • Principal Investigator:
          • Lin Zhang, M.D.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in total atheroma volume (TAV)
Time Frame: 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
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major cardiovascular events (MACEs)
Time Frame: 5 years
A composite endpoint of cardiovascular death, non-fatal myocardial infarction, and unplanned revascularization during follow-up
5 years
Cardiovascular death
Time Frame: 5 years
The occurrence of cardiovascular death during follow-up
5 years
Myocardial infarction
Time Frame: 5 years
The occurrence of myocardial infarction during follow-up
5 years
Unplanned revascularization
Time Frame: 5 years
The occurrence of unplanned revascularization during follow-up
5 years
Changes in calcified plaque volume
Time Frame: 24 months
Changes in calcified plaque volume in whole heart and in target lesions measured by coronary CTA and quantification analysis at baseline and during follow-up
24 months
Changes in non-calcified plaque volume
Time Frame: 24 months
Changes in non-calcified plaque volume in whole heart and in target lesions measured by coronary CTA and quantification analysis at baseline and during follow-up
24 months
Changes in fibrous plaque volume
Time Frame: 24 months
Changes in fibrous plaque volume in whole heart and in target lesions measured by coronary CTA and quantification analysis at baseline and during follow-up
24 months
Changes in fibrousfatty plaque volume
Time Frame: 24 months
Changes in fibrousfatty plaque volume in whole heart and in target lesions measured by coronary CTA and quantification analysis at baseline and during follow-up
24 months
Changes in necrotic core volume
Time Frame: 24 months
Changes in plaque necrotic core volume in whole heart and in target lesions measured by coronary CTA and quantification analysis at baseline and during follow-up
24 months
Changes in high-risk plaque (HRP) features
Time Frame: 24 months
Changes in the number of HRP features in whole heart and in target lesions measured by coronary CTA at baseline and during follow-up.
24 months
Changes in perivascular adipose tissue (PVAT) volume
Time Frame: 24 months
Changes in the volume of PVAT measured by coronary CTA and quantification analysis at baseline and during follow-up
24 months
Changes in perivascular adipose tissue (PVAT) density
Time Frame: 24 months
Changes in the density of PVAT measured by coronary CTA and quantification analysis at baseline and during follow-up
24 months
Changes in perivascular adipose tissue (PVAT) distribution
Time Frame: 24 months
Changes in the distribution of PVAT measured by coronary CTA and quantification analysis at baseline and during follow-up
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

Investigators

  • Principal Investigator: Ruiyan Zhang, M.D., Ph.D., Ruijin Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

May 31, 2030

Study Registration Dates

First Submitted

January 14, 2025

First Submitted That Met QC Criteria

January 21, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 21, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RJH-PRACTICE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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