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Completed

NCT Number: NCT04797819

Serum Soluble ST2 and Plaque Vulnerability in Patients With 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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cardiology, Ren Ji Hospital

Shanghai, China

About this study

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).

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Coronary plaque components

Diagnostic Test

Coronary plaque components were detected by CCTA method

Primary outcomes

  1. Distribution of plaque components by QAngioCT

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 15, 2021
Registry last updated
Mar 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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