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临床试验/NCT04595630
NCT04595630招募中不适用

Diagnostic and Prognostic Value of Cardiac Biomarkers for Early Coronary Bypass Occlusion in Patients Undergoing Coronary Revascularization

University Hospital, Basel, Switzerland3 个研究点 分布在 3 个国家目标入组 480 人开始时间: 2021年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
480
试验地点
3
主要终点
Change in hs-cTn level (ng/L)

研究概览

简要总结

This study is to evaluate the correlation between hs-cTn level as cardiac biomarker for ischemia and early graft occlusion as assessed by CCT in patients undergoing coronary bypass surgery.

详细描述

The early diagnosis of the periprocedural myocardial infarction (MI) due to the bypass graft occlusion is an important element, in order to introduce early therapeutic strategies. Invasive coronary angiography (CA) is the gold standard to evaluate the postoperative myocardial ischemia due to the graft occlusion. Since this procedure has several important risks, such as thromboembolic events, dissection, bleeding, and contrast dye-induced nephropathy, in daily clinical practice, only patients with strong clinical suspicion of early MI following coronary artery bypass grafting (CABG) undergo this invasive procedure. There is a clinical need for the development of safe and accurate non-invasive diagnostic approaches to assess the early coronary bypass graft occlusion and to predict the consequent MI. A new clinical approach for the identification of the early post-procedural graft occlusion in patients undergoing CABG surgery is the high-sensitivity cardiac troponin (hs-cTn) cut-off level. The peri-operative bypass occlusion will be assessed by a Coronary Computed Tomography (CCT) scan which is a widely available non-invasive approach that permits an accurate evaluation of coronary stenosis. This study is to evaluate the correlation between hs-cTn level as cardiac biomarker for ischemia and early graft occlusion as assessed by CCT in patients undergoing coronary bypass surgery.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with isolated coronary bypass surgery

排除标准

  • Patients withholding or lacking informed consent
  • Patients requiring a concomitant procedure
  • Exclusion criteria concerning the CCT scan
  • Patients with known allergy to iodine-containing contrast agents
  • Renal function impairment (serum creatinine >140 mmol/l; estimated glomerular filtration rate (GFR) <30 ml/min/1.73 m2).
  • Pregnancy
  • Unstable clinical state or severe heart failure
  • Patients with registered MI and registered bypass occlusion in coronary angiogram
  • Patients that didn't undergo a CCT prior to discharge

结局指标

主要结局

Change in hs-cTn level (ng/L)

时间窗: Day 0 to discharge date (max 10 days)

hs-cTn level following CABG to correlate between hs-cTn level as cardiac biomarker for ischemia and early graft occlusion as assessed by CCT

次要结局

  • Stroke rate during hospital stay(Day 0 to discharge date (max 10 days))
  • Incidence of major adverse cardiac and cerebrovascular events (MACCE) during hospital stay(Day 0 to discharge date (max 10 days))
  • All-cause mortality during hospital stay (death before discharge)(Day 0 to discharge date (max 10 days))
  • Cardiac-related mortality during hospital stay(Day 0 to discharge date (max 10 days))
  • Myocardial infarction during hospital stay(Day 0 to discharge date (max 10 days))
  • Surgical or percutaneous coronary re-intervention during hospital stay(Day 0 to discharge date (max 10 days))

研究者

发起方
University Hospital, Basel, Switzerland
申办方类型
Other
责任方
Sponsor

研究点 (3)

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