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

Completed

• Conditions: Acute Coronary Syndrome
• Interventions: Diagnostic Test: HRP frequency, plaque compostion and local immune-inflammatory activation

• Registration Number: NCT04792047
• Lead Sponsor: RenJi Hospital

Brief Summary

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.

Detailed Description

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).

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2020-01-31
• Study Completion: 2020-01-31
• Status Verified: 2021-02
• Study First Submitted: 2021-02-25
• Study First Submitted QC: 2021-03-08
• Last Update Submitted: 2021-03-08
• Study First Posted: 2021-03-10
• Last Update Posted: 2021-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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

1. 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;
2. 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.
3. After CCTA performance, we also exclude patients with no significant (≥50%) stenosis on major epicardial vessels and those refused subsequent angiography.
4. 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lesions with perivasular FAI greater than ≥-70.1	HRP frequency, plaque compostion and local immune-inflammatory activation	-
Lesions with perivasular FAI greater than <-70.1	HRP frequency, plaque compostion and local immune-inflammatory activation	-

Primary Outcome Measures

Name	Time	Method
Frequency of HRP by CCTA	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 Outcome Measures

Name	Time	Method
Distribution of plaque composition by Qangio	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.

Trial Locations

Locations (1)

Cardiology, Ren Ji Hospital; 🇨🇳 Shanghai, China