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临床试验/NCT05686057
NCT05686057招募中不适用

The Effect of Cardiac Ischemia and Percutaneous Coronary Intervention on the Changes of sST2 Level

Assiut University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
2
主要终点
sST2 biomarker level

研究概览

简要总结

The role of soluble circulating suppression of tumorigenicity 2 biomarker (sST2) in the ischemic heart disease patient is a debatable point. Therefore the aims of this study are to assess the plasma level of sST2 in ischemic heart disease patients versus non-ischemic ones, the acute changes in its level after percutaneous coronary intervention (PCI) and its relation to the severity of ischemia.

详细描述

A comparison of ischemic patients and non-ischemic controls will be done. The plasma level of sST2 will be withdrawn at baseline and 24-48 hours after the intervention in ischemic group. Then a study ischemic group will be divided into three subgroups; subgroup-1: single vessel disease, subgroup-2: two vessels disease and subgroup-3: multivessels disease. On admission, there will be a significant difference between the group of acute/chronic coronary syndrome cases and controls as regard sST2 plasma level or not. Moreover, the differences between the three ischemic subgroups at the baseline ST2 level will be assessed. The plasma sST2 level after PCI and the correlation between the acute change in pot-PCI sST2 level and the severity of ischemia by Modified Gensini Score (MGS) will be evaluated. The final question that will be answered by this study does the rapid impact of PCI on sST2 level will be mainly related to the severity of ischemia rather than left ventricular function or not.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • Any patients aged 40 years or more and have the risk factors of ischemic heart disease (IHD) with coronary artery disease symptoms will be included.
  • For control subjects should be aged ≥ 40 years old with IHD risk factors including DM and HTN and without any symptoms or signs of cardiac ischemia.

排除标准

  • Any patient with heart failure (EF <50%), any patients with rhythm abnormalities including atrial fibrillation, obese patients, structural heart diseases, uncontrolled chronic diseases such as hypertension or diabetes mellitus, any pulmonary artery or parenchymal diseases up to respiratory failure, acute systemic infection or inflammation, and chronic/acute renal diseases.

结局指标

主要结局

sST2 biomarker level

时间窗: 48 hours post percutanous coronary intervention

follow up of only ischemic heart disease groups of sST2 level changes after intervention

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Areej Ahmad Abdullah Tammam Alkhateeb

Lecturer of Cardiology

Assiut University

研究点 (2)

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