Serum Soluble ST2 and Plaque Vulnerability in Patients With Acute Coronary Syndrome

Sponsor

RenJi Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04797819

Collaborator

(none)

120

Enrollment

Location

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aimed to assess the association between serum sST2 level and plaque vulnerability in ACS patients. It is hypothesized that serum sST2 level may be related to plaque components and closely associated with plaque vulnerability.

Condition or Disease	Intervention/Treatment	Phase
Acute Coronary Syndrome	Diagnostic Test: Coronary plaque components

Detailed Description

Serum soluble suppression of tumorigenicity-2 (sST2) has emerged as a novel biomarker of atherosclerotic disease. This study aimed to investigate whether elevated serum sST2 level is related to coronary plaque components detected on coronary computed tomography angiography (CCTA) and plaque vulnerability in non-ST elevation acute coronary syndromes (ACS) patients. 167 lesions in 120 non-ST elevation ACS patients were prospectively enrolled and evaluated by CCTA in this study. Blood were taken from antecubital vein during patient's hospitalization for angiography. Serum sST2 level was measured by commerical ELISA kits (Presage ST2 Assay Kit, Critical Diagnostics). CCTA were performed using a 320-slice CT scanner (Aquilion ONE, Toshiba Medical Systems, Otawara, Japan). Coronary plaque components were analyzed cross each of the lesions using commercialized software package (QAngio CT, Medis, The Netherlands).

Study Design

Study Type:

Observational

Actual Enrollment :

120 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Elevated Serum Soluble ST2 Level is Associated With Increased Plaque Vulnerability in Patients With Non-ST Elevation Acute Coronary Syndrome

Actual Study Start Date :

Jan 1, 2019

Actual Primary Completion Date :

Dec 31, 2019

Actual Study Completion Date :

Dec 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Serum sST2 level < 14.5 ng/mL	Diagnostic Test: Coronary plaque components Coronary plaque components were detected by CCTA method
14.5 ng/mL ≤ Serum sST2 level < 20.5 ng/mL	Diagnostic Test: Coronary plaque components Coronary plaque components were detected by CCTA method
20.5 ng/mL ≤ Serum sST2 level < 25.9 ng/mL	Diagnostic Test: Coronary plaque components Coronary plaque components were detected by CCTA method
Serum sST2 level ≥ 25.9 ng/mL	Diagnostic Test: Coronary plaque components Coronary plaque components were detected by CCTA method

Outcome Measures

Primary Outcome Measures

Distribution of plaque components by QAngioCT [Procedure (Coronary CTA )]
Hounsfield unit (HU) -30 to 75 for necrotic core, HU 76-130 for fibrous fatty, HU 131-350 for fibrous tissue, and HU over 351 for dense calcium.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Inclusion Criteria:

Clinical diagnosis of non-ST-elevation ACS
Non-ST-elevation myocardial infarction
Unstable angina
Age from 18 to 75 years
Underwent CCTA

Exclusion Criteria:

Patients needed an immediate (< 2 h) or early invasive strategy (< 24 h) according to guidelines:
Haemodynamic instability
Cardiogenic shock
Life-threatening arrhythmias or cardiac arrest
Mechanical complication
Acute heart failure
Dynamic ST or T wave changes
GRACE score > 140
Patients with previous history of:
Coronary artery bypass graft surgery or percutaneous coronary intervention (PCI)
Immune system disorder
Tumor
Acute/chronic infection
Statin use within 3 months
Atrial fibrillation
End-stage renal failure
Iodine-containing contrast allergy
Patients with no significant (≥ 50%) stenosis on major epicardial vessels after CCTA performance
Patients refused subsequent angiography after CCTA performance
Patients with total obstruction on major epicardial vessel
Patients with insufficient image quality for QAngioCT analysis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cardiology, Ren Ji Hospital	Shanghai		China

Sponsors and Collaborators

RenJi Hospital

Investigators

Principal Investigator: Song Ding, RenJi Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

RenJi Hospital

ClinicalTrials.gov Identifier:

NCT04797819

Other Study ID Numbers:

sST2 and plaque vulnerability

First Posted:

Mar 15, 2021

Last Update Posted:

Mar 24, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by RenJi Hospital

soluble ST2

plaque vulnerability

Additional relevant MeSH terms:

Acute Coronary Syndrome

Syndrome

Study Results

No Results Posted as of Mar 24, 2021