NCT05590858

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
309

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

October 19, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 21, 2022

Completed
Last Updated

October 21, 2022

Status Verified

October 1, 2022

Enrollment Period

2 years

First QC Date

October 19, 2022

Last Update Submit

October 20, 2022

Conditions

Inflammation Vascular

Keywords

diabetes mellitusacute coronary syndromecoronary inflammationcoronary computed tomography angiographyfat attenuation index

Outcome Measures

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.

    2021.1.1-2022.10.31

Secondary Outcomes (2)

  • Level of hsCRP

    2021.1.1-2022.10.31

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

    2021.1.1-2022.10.31

Study Arms (3)

non-diabetes

patients without diabetes

well-regulated diabetes

patients with diabetes and HbA1c ≤ 7%

poorly regulated diabetes

patients with diabetes and HbA1c \> 7%

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200127, China

Location

Related Publications (2)

  • 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.

    PMID: 35023363BACKGROUND

  • 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.

    PMID: 39077018DERIVED

MeSH Terms

Conditions

Diabetes MellitusAcute Coronary Syndrome

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Song Ding, Doctor

    RenJi Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2022

First Posted

October 21, 2022

Study Start

January 1, 2019

Primary Completion

December 31, 2020

Study Completion

October 1, 2022

Last Updated

October 21, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)