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CompletedNCT05590858Updated Oct 21, 2022

Glycemic Control on Coronary Inflammation Evaluated by FAI in ACS

An observational study in Inflammation Vascular, sponsored by RenJi Hospital. Completed at 1 site in China. Per ClinicalTrials.gov, last updated 2022-10-21.

Sponsored by RenJi Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
309
Sex
All
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Study summary

This study aimed to clarify the relationship between blood glucose control and the FAI based pericoronary inflammation in low-risk ACS patients with or without diabetes. The results of this study are expected to provide evidence that quantitative assessment of pericoronary FAI helps monitor the local inflammatory activation in diabetic patients with poor glycemic control, therefore, pericoronary FAI evaluation, as a noninvasive imaging biomarker, plays an important role in early detecting coronary atherosclerosis risk in diabetes and allow timely providing appropriate risk reduction strategies in patients at high risk for future cardiovascular events.

Read the detailed description

Coronary inflammation has been shown to be a cause of the significantly increased risk of cardiovascular disease (CVD) in diabetic patients. This study aimed to investigate the relationship between coronary local inflammation detected by pericoronary fat attenuation index (FAI) and different blood glucose control levels in low-risk acute coronary syndrome (ACS) patients with or without diabetes.A total of 309 patients with low-risk ACS were included in the analysis. Patients were classified into three groups: non-diabetes, well-regulated diabetes and poorly regulated diabetes, depend on the presence or absence of diabetes and the glycemic control evaluated based on a target HbA1c value of 7%. Pericoronary FAI around the proximal of left anterior descending artery (LAD), left circumflex artery (LCX), and right coronary artery (RCA) were evaluated by CCTA, while systemic inflammatory variables and other biochemical indicators were detected by flow cytometry. The results of this study are expected to provide evidence that quantitative assessment of pericoronary FAI helps monitor the local inflammatory activation in diabetic patients with poor glycemic control, therefore, pericoronary FAI evaluation, as a noninvasive imaging biomarker, plays an important role in early detecting coronary atherosclerosis risk in diabetes and allow timely providing appropriate risk reduction strategies in patients at high risk for future cardiovascular events.

02

Conditions studied

  • Inflammation Vascular

Keywords

  • diabetes mellitus
  • acute coronary syndrome
  • coronary inflammation
  • coronary computed tomography angiography
  • fat attenuation index
03

In context

Acute Coronary Syndrome

1,462 studies on the registry are indexed under Acute Coronary Syndrome; 267 are open to participants now.

This study's enrollment of 309 is below the median of 503 across 562 observational studies indexed under Acute Coronary Syndrome.

Browse Acute Coronary Syndrome studies →

Lead sponsor

RenJi Hospital is the lead sponsor of 535 studies on the registry; 244 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

low-risk ACS patients who underwent CCTA examination before elective coronary angiography between January 2019 and December 2020 at Renji Hospital

Inclusion criteria

  • patients exhibited chest pain but troponin negative who suspected of low-risk ACS[17];
  • patients underwent CCTA examination before elective coronary angiography;
  • patients with at least one significant stenosis (≥50%) in major epicardial vessels based on coronary angiography.

Exclusion criteria

Exclusion Criteria:

  • patients with missing preprocedural HbA1c values;
  • patients with insufficient image quality for FAI analysis,
  • patients with previous history of coronary revascularization or myocardial infarction, or chronic kidney disease requiring hemodialysis, or malignant tumor, or immune system disorders, or statin use within 3 months
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
309 participants (actual)
Patient registry
No

Groups and cohorts

  • non-diabetes

    patients without diabetes

  • well-regulated diabetes

    patients with diabetes and HbA1c ≤ 7%

  • poorly regulated diabetes

    patients with diabetes and HbA1c \> 7%

06

What researchers measure

Primary outcomes

  1. pericoronary Fat attenuation index (FAI)

    The pericoronary FAI was defined as the mean CT attenuation of the pericoronary adipose tissue (-190 to -30 HU). Peri-stent FAI was measured around the stent segment of all 3 major epicardial coronary vessels.

    Time frame: 2021.1.1-2022.10.31

Secondary outcomes

  1. Level of hsCRP

    Time frame: 2021.1.1-2022.10.31

  2. level of pro-inflammatory cytokines such as IL-2 and IL-6.

    Time frame: 2021.1.1-2022.10.31

07

Study locations

1 site
  • Cardiology, Renji Hospital, Shanghai Jiao Tong University School of Medicine
    Shanghai, Shanghai 200127, China
08

References and documents

Publications

  • 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. PubMed 35023363 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05590858
Lead sponsor
RenJi Hospital
Responsible party
Sponsor
First posted
Oct 21, 2022
Start date
Jan 1, 2019
Primary completion
Dec 31, 2020
Completion
Oct 1, 2022
Last update
Oct 21, 2022

Study contacts

Song Ding, Doctor
principal investigator · RenJi Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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