Clinical trial NCT05590858: Glycemic Control on Coronary Inflammation Evaluated by FAI in ACS
Official title: Impact of Glycemic Control on Coronary Inflammation Evaluated by Computed Tomography Pericoronary Fat Attenuation Index in Patients With Acute Coronary Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammation Vascular
Keywords: diabetes mellitus
acute coronary syndrome
coronary inflammation
coronary computed tomography angiography
fat attenuation index
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2022-10-21
Enrollment: 309
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: pericoronary Fat attenuation index (FAI)
timeFrame: 2021.1.1-2022.10.31
Secondary outcomes:
measure: Level of hsCRP
timeFrame: 2021.1.1-2022.10.31
measure: level of pro-inflammatory cytokines such as IL-2 and IL-6.
timeFrame: 2021.1.1-2022.10.31
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Cardiology, Renji Hospital, Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
affiliation: RenJi Hospital
name: Song Ding, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.