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

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Coronary Syndrome
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Cardiology, Ren Ji Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Between January 2019 and December 2019, a total of 120 patients with 167 lesions were included in our study for final analysis.

Description

Inclusion Criteria:

1. Clinical diagnosis of non-ST-elevation ACS

   1. Non-ST-elevation myocardial infarction
   2. Unstable angina
2. Age from 18 to 75 years
3. Underwent CCTA

Exclusion Criteria:

1. Patients needed an immediate (< 2 h) or early invasive strategy (< 24 h) according to guidelines:

   1. Haemodynamic instability
   2. Cardiogenic shock
   3. Life-threatening arrhythmias or cardiac arrest
   4. Mechanical complication
   5. Acute heart failure
   6. Dynamic ST or T wave changes
   7. GRACE score > 140

2. Patients with previous history of:

   1. Coronary artery bypass graft surgery or percutaneous coronary intervention (PCI)
   2. Immune system disorder
   3. Tumor
   4. Acute/chronic infection
   5. Statin use within 3 months
   6. Atrial fibrillation
   7. End-stage renal failure
   8. Iodine-containing contrast allergy
3. Patients with no significant (≥ 50%) stenosis on major epicardial vessels after CCTA performance
4. Patients refused subsequent angiography after CCTA performance
5. Patients with total obstruction on major epicardial vessel
6. Patients with insufficient image quality for QAngioCT analysis

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distribution of plaque components by QAngioCT	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.	Procedure (Coronary CTA )

Collaborators and Investigators

• Sponsor: RenJi Hospital

Publications and helpful links

General Publications

• Luo G, Qian Y, Sheng X, Sun J, Wu Z, Liao F, Feng Q, Yin Y, Ding S, Pu J. Elevated Serum Levels of Soluble ST2 Are Associated With Plaque Vulnerability in Patients With Non-ST-Elevation Acute Coronary Syndrome. Front Cardiovasc Med. 2021 Jul 22;8:688522. doi: 10.3389/fcvm.2021.688522. eCollection 2021.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: March 12, 2021
• First Submitted That Met QC Criteria: March 12, 2021
• First Posted (Actual): March 15, 2021

Study Record Updates

• Last Update Posted (Actual): March 24, 2021
• Last Update Submitted That Met QC Criteria: March 20, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: plaque vulnerability; soluble ST2
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Syndrome; Acute Coronary Syndrome
• Other Study ID Numbers: sST2 and plaque vulnerability

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No