- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04792047
Pericoronary Fat Attenuation Index and High-risk Plaque in Patients With Acute Coronary Syndrome
March 8, 2021 updated by: RenJi Hospital
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
130
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Shanghai, China
- Cardiology, Ren Ji Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 71 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Lesions with perivasular FAI greater than ≥-70.1
|
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
|
HRP frequency, plaque compostion were detected by CCTA method.
Local T cell subsets and their intracellular cytokines levels were detected by Flow Cytometry.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
coronary CTA analysis, before angiography
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
coronary CTA analysis, before angiography
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Concentration of local immune-inflammatory cytokines
Time Frame: blood were taken immediately after the diagnostic angiography
|
quantification of local immune-inflammatory cytokines
|
blood were taken immediately after the diagnostic angiography
|
|
Concentration of local T subset
Time Frame: blood were taken immediately after the diagnostic angiography
|
quantification of local T subset
|
blood were taken immediately after the diagnostic angiography
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2019
Primary Completion (Actual)
January 31, 2020
Study Completion (Actual)
January 31, 2020
Study Registration Dates
First Submitted
February 25, 2021
First Submitted That Met QC Criteria
March 8, 2021
First Posted (Actual)
March 10, 2021
Study Record Updates
Last Update Posted (Actual)
March 10, 2021
Last Update Submitted That Met QC Criteria
March 8, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FAI and HRP study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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