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Completed

NCT Number: NCT05590858

Glycemic Control on Coronary Inflammation Evaluated by FAI in ACS

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Cardiology, Renji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200127, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Primary outcomes

  1. pericoronary Fat attenuation index (FAI)

    Time frame: 2021.1.1-2022.10.31

    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.

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

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Official study title

Impact of Glycemic Control on Coronary Inflammation Evaluated by Computed Tomography Pericoronary Fat Attenuation Index in Patients With Acute Coronary Syndrome

Important dates

Study start
2019
Primary completion
2020
Study completion
2022
First posted
Oct 21, 2022
Registry last updated
Oct 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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