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NCT Number: NCT06794684

PRogression of Atheroma Evaluated by CT Angiography and IntraCoronary Imaging tEchniques

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CAAC East China Aviation Personnel Medical Appraisal Center, Civil Aviation Shanghai Hospital, Shanghai, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Major cardiovascular events (MACEs)

    Time frame: 5 years

    A composite endpoint of cardiovascular death, non-fatal myocardial infarction, and unplanned revascularization during follow-up

  2. Cardiovascular death

    Time frame: 5 years

    The occurrence of cardiovascular death during follow-up

  3. Myocardial infarction

    Time frame: 5 years

    The occurrence of myocardial infarction during follow-up

  4. Unplanned revascularization

    Time frame: 5 years

    The occurrence of unplanned revascularization during follow-up

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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.

  11. 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

  12. 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

  13. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

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

Acronym: PRACTICE

Important dates

Study start
2016
Primary completion
2027
Study completion
2030
First posted
Jan 27, 2025
Registry last updated
Jan 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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