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

Acute Coronary Syndrome Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04792047
• Other study ID #: FAI and HRP study
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: January 31, 2020

Study information

• Verified date: February 2021
• Source: RenJi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: January 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Diagnostic Test:
• HRP frequency, plaque compostion and local immune-inflammatory activation
HRP frequency, plaque compostion were detected by CCTA method. Local T cell subsets and their intracellular cytokines levels were detected by Flow Cytometry.

Locations

Country	Name	City	State
China	Cardiology, Ren Ji Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Concentration of local immune-inflammatory cytokines	quantification of local immune-inflammatory cytokines	blood were taken immediately after the diagnostic angiography
Other	Concentration of local T subset	quantification of local T subset	blood were taken immediately after the diagnostic angiography
Primary	Frequency of HRP by CCTA	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.	coronary CTA analysis, before angiography
Secondary	Distribution of plaque composition by Qangio	HU -30 to 75, for necrotic core;HU 76-130 for fibro-fatty; HU131-350 for fibrous, and HU> 351 for dense calcium.	coronary CTA analysis, before angiography