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Completed

NCT Number: NCT04792047

Pericoronary Fat Attenuation Index and High-risk Plaque in Patients With Acute Coronary Syndrome

This study aimed to investigate the relationship between CCTA-based pericoronary inflammation and plaque features as well as local immune-inflammatory biomarkers in ACS patients. It is hypothesized that perivascular FAI might serve as a reliable sensor of coronary immune-inflammatory disorder, and closely related to the plaque vulnerability.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cardiology, Ren Ji Hospital

Shanghai, China

About this study

The pericoronary fat attenuation index (FAI), which capture by standard coronary computed tomography angiography (CCTA), has emerged as a novel imaging biomarker of coronary inflammation. This study aimed to assess whether increased Pericoronary FAI on CCTA are associated with high-risk plaque (HRP) feature as well as local T cell subsets and their intracellular cytokines levels in non-ST elevation acute coronary syndromes ( ACS) patients. 195 lesions in 130 non-ST elevation ACS patients were prospectively enrolled and evaluated by CCTA and coronary angiography in this study. Blood were taken from coronary artery immediately after the diagnostic angiogram. Local T cell subsets and their intracellular cytokines levels were detected by Flow Cytometry. CCTA and pericoronary FAI examinations were performed using a 320-detecor (Aquilion ONE, Toshiba Medical Systems, Otawara, Japan) Systems. Coronary plaque characteristics were analyzed cross each of the main coronary arteries using commercialized software package (Qangio CT, Medis, The Netherlands).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • non-ST-elevation ACS (non-ST-elevation myocardial infarction or unstable angina) age from 18 to 75 years which underwent CCTA were prospectively enrolled in this study.

Exclusion criteria

  • Patients needed an immediate (<2 h) or early invasive strategy (<24 h) according to guidelines were excluded: including those presented with haemodynamic instability or cardiogenic shock, life-threatening arrhythmia or cardiac arrest, mechanical complication, acute heart failure, dynamic ST or T wave changes, GRACE score >140;
  • Subjects with previous history of coronary artery bypass graft surgery or PCI, immune system disorder, tumor, acute/chronic infection, atrial fibrillation, end-stage renal failure, iodine-containing contrast allergy were also excluded.
  • After CCTA performance, we also exclude patients with no significant (≥50%) stenosis on major epicardial vessels and those refused subsequent angiography.
  • Participants with total obstruction on major epicardial vessel, or insufficient image quality for FAI and QangioCT analysis, as well as lack of blood sample were excluded.

Treatment and study plan

HRP frequency, plaque compostion and local immune-inflammatory activation

Diagnostic Test

HRP frequency, plaque compostion were detected by CCTA method. Local T cell subsets and their intracellular cytokines levels were detected by Flow Cytometry.

Primary outcomes

  1. Frequency of HRP by CCTA

    Time frame: coronary CTA analysis, before angiography

    HRP features were defined according to previous studies as follow: low-attenuation plaque (LAP), mean CT number <30 HU; positive remodeling(PR), remodeling index, >1.1; spotty calcification(SC), intraplaque calcification ≤3 mm; Napkin-ring sign, low intraplaque attenuation surrounded by a higher attenuation rim.

Secondary outcomes

  1. Distribution of plaque composition by Qangio

    Time frame: coronary CTA analysis, before angiography

    HU -30 to 75, for necrotic core;HU 76-130 for fibro-fatty; HU131-350 for fibrous, and HU> 351 for dense calcium.

Other outcomes

  1. Concentration of local immune-inflammatory cytokines

    Time frame: blood were taken immediately after the diagnostic angiography

    quantification of local immune-inflammatory cytokines

  2. Concentration of local T subset

    Time frame: blood were taken immediately after the diagnostic angiography

    quantification of local T subset

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Official study title

Increased Pericoronary Fat Attenuation Index is Associated With High-risk Plaque and Local Immune-inflammatory Activation in Patients With Non-ST Elevation Acute Coronary Syndrome

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 10, 2021
Registry last updated
Mar 10, 2021

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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