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

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ClinicalTrials.gov Identifier: NCT04792047
Recruitment Status : Completed
First Posted : March 10, 2021
Last Update Posted : March 10, 2021
Sponsor:
Information provided by (Responsible Party):
RenJi Hospital

Study Description
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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
Acute Coronary Syndrome 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
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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 : January 1, 2019
Actual Primary Completion Date : January 31, 2020
Actual Study Completion Date : January 31, 2020
Groups and Cohorts
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Group/Cohort 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
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability 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.
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04792047


Locations
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China
Cardiology, Ren Ji Hospital
Shanghai, China
Sponsors and Collaborators
RenJi Hospital
Investigators
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Principal Investigator: Song Ding RenJi Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: RenJi Hospital
ClinicalTrials.gov Identifier: NCT04792047    
Other Study ID Numbers: FAI and HRP study
First Posted: March 10, 2021    Key Record Dates
Last Update Posted: March 10, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by RenJi Hospital:
pericoronary fat attenuation index
high-risk plaque
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Syndrome
Disease
Pathologic Processes
 Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases