Glycemic Control on Coronary Inflammation Evaluated by FAI in ACS

NCT ID: NCT05590858

Last Updated: 2022-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

309 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2022-10-01

Brief Summary

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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

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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.

Conditions

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Inflammation Vascular

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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non-diabetes

patients without diabetes

No interventions assigned to this group

well-regulated diabetes

patients with diabetes and HbA1c ≤ 7%

No interventions assigned to this group

poorly regulated diabetes

patients with diabetes and HbA1c \> 7%

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Song Ding, Doctor

Role: PRINCIPAL_INVESTIGATOR

RenJi Hospital

Locations

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

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 35023363 (View on PubMed)

Jiang J, Yin Y, Li Y, Xu B, Zou Z, Ding S, Pu J. Impact of Glycemic Control on Coronary Inflammation Evaluated by Computed Tomography Pericoronary Fat Attenuation Index in Patients with Acute Coronary Syndrome. Rev Cardiovasc Med. 2023 Jul 14;24(7):203. doi: 10.31083/j.rcm2407203. eCollection 2023 Jul.

Reference Type DERIVED
PMID: 39077018 (View on PubMed)

Other Identifiers

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FAI-DM in ACS

Identifier Type: -

Identifier Source: org_study_id

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