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临床试验/NCT04797819
NCT04797819已完成不适用

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

RenJi Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
Distribution of plaque components by QAngioCT

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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
  • 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

结局指标

主要结局

Distribution of plaque components by QAngioCT

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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