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

NCT04797819 | Completed

• 1 other identifier: sST2 and plaque vulnerability
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Coronary Syndrome

Keywords

soluble ST2; plaque vulnerability

Outcome Measures

Primary Outcomes (1)

• 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 )

Study Arms (4)

Serum sST2 level < 14.5 ng/mL

Diagnostic Test: Coronary plaque components

14.5 ng/mL ≤ Serum sST2 level < 20.5 ng/mL

Diagnostic Test: Coronary plaque components

20.5 ng/mL ≤ Serum sST2 level < 25.9 ng/mL

Diagnostic Test: Coronary plaque components

Serum sST2 level ≥ 25.9 ng/mL

Diagnostic Test: Coronary plaque components

Interventions

Coronary plaque components DIAGNOSTIC_TEST

Coronary plaque components were detected by CCTA method

14.5 ng/mL ≤ Serum sST2 level < 20.5 ng/mL; 20.5 ng/mL ≤ Serum sST2 level < 25.9 ng/mL; Serum sST2 level < 14.5 ng/mL; Serum sST2 level ≥ 25.9 ng/mL

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Cardiology, Ren Ji Hospital

Shanghai, China

Location

Related Publications (1)

• 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.

  PMID: 34368249 DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Song Ding

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2021
• First Posted: March 15, 2021
• Study Start: January 1, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: March 24, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)