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

Sponsor
RenJi Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04792047
Collaborator
(none)
130
1
13
10

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: HRP frequency, plaque compostion and local immune-inflammatory activation

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 Design

Study Type:
Observational
Actual Enrollment :
130 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Actual Study Start Date :
Jan 1, 2019
Actual Primary Completion Date :
Jan 31, 2020
Actual Study Completion Date :
Jan 31, 2020

Arms and Interventions

Arm Intervention/Treatment
Lesions with perivasular FAI greater than ≥-70.1

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.

Lesions with perivasular FAI greater than <-70.1

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

Other Outcome Measures

  1. Concentration of local immune-inflammatory cytokines [blood were taken immediately after the diagnostic angiography]

    quantification of local immune-inflammatory cytokines

  2. Concentration of local T subset [blood were taken immediately after the diagnostic angiography]

    quantification of local T subset

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cardiology, Ren Ji Hospital Shanghai China

Sponsors and Collaborators

  • RenJi Hospital

Investigators

  • Principal Investigator: Song Ding, RenJi Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
RenJi Hospital
ClinicalTrials.gov Identifier:
NCT04792047
Other Study ID Numbers:
  • FAI and HRP study
First Posted:
Mar 10, 2021
Last Update Posted:
Mar 10, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by RenJi Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 10, 2021