NCT04792047

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 25, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 10, 2021

Completed
Last Updated

March 10, 2021

Status Verified

February 1, 2021

Enrollment Period

1.1 years

First QC Date

February 25, 2021

Last Update Submit

March 8, 2021

Conditions

Acute Coronary Syndrome

Keywords

pericoronary fat attenuation indexhigh-risk plaque

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Distribution of plaque composition by Qangio

    coronary CTA analysis, before angiography

Other Outcomes (2)

  • Concentration of local immune-inflammatory cytokines

    blood were taken immediately after the diagnostic angiography

  • Concentration of local T subset

    blood were taken immediately after the diagnostic angiography

Study Arms (2)

Lesions with perivasular FAI greater than ≥-70.1

Diagnostic Test: HRP frequency, plaque compostion and local immune-inflammatory activation

Lesions with perivasular FAI greater than <-70.1

Diagnostic Test: HRP frequency, plaque compostion and local immune-inflammatory activation

Interventions

HRP frequency, plaque compostion and local immune-inflammatory activationDIAGNOSTIC_TEST

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 <-70.1Lesions with perivasular FAI greater than ≥-70.1

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Between January 2019 and January 2020, a total of 130 patients with 195 lesions were included in our study for final analysis.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiology, Ren Ji Hospital

Shanghai, China

Location

Related Publications (1)

  • Sun JT, Sheng XC, Feng Q, Yin Y, Li Z, Ding S, Pu J. Pericoronary Fat Attenuation Index Is Associated With Vulnerable Plaque Components and Local Immune-Inflammatory Activation in Patients With Non-ST Elevation Acute Coronary Syndrome. J Am Heart Assoc. 2022 Jan 18;11(2):e022879. doi: 10.1161/JAHA.121.022879. Epub 2022 Jan 13.

    PMID: 35023363DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Song Ding

    RenJi Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2021

First Posted

March 10, 2021

Study Start

January 1, 2019

Primary Completion

January 31, 2020

Study Completion

January 31, 2020

Last Updated

March 10, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)