跳至主要内容
临床试验/NCT02632617
NCT02632617Unknown不适用

coRonary assEssment of Preoperative vaLvulopathy pAtients Using ComputEd Tomographic Angiography (REPLACE)

Chinese Academy of Medical Sciences, Fuwai Hospital5 个研究点 分布在 1 个国家目标入组 2,644 人开始时间: 2015年12月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
2,644
试验地点
5
主要终点
Incidence of cardiovascular complications and mortality [Perioperative Safety]

研究概览

简要总结

Preoperative detection of combined coronary artery disease by invasive coronary angiography (ICA) is recommended in American Heart Association (AHA)/American College of Cardiology (ACC) guidelines for most patients (>40 yrs male or postmenopausal female) scheduled for heart valve surgery, but the low incident rate of coronary artery disease implied guidelines for the vast majority who ultimately will not undergo revascularization. Computed tomography angiography (CTA) has emerged as an alternative diagnosis procedure, which has the following advantages: non-invasive, low cost, provide information of lung and mediastinum. Our study is to evaluate the feasibility of computed tomography, instead of conventional invasive coronary angiography in evaluating coronary artery lesion prior to the heart valvular operation.

详细描述

Valvular heart disease is common in China, either rheumatic or degenerative, and valvular repair or replacement surgery is the important therapeutic method. In all forms of heart valvular disease, combined coronary artery disease worsens perioperative prognosis. Preoperative detection of combined coronary artery disease with invasive coronary angiography is recommended in most patients scheduled for valve surgery, while incidence rate of coronary artery disease in patients with valvular disease showed that only 3%-19% patients were diagnosed with significant stenosis. Although invasive coronary angiography is considered a safe procedure, it still carries a small risk of major (death, stroke, or vascular dissection) and minor (inguinal hematoma) complications. Furthermore, the catheterization procedure is rather expensive, as its invasive nature involves admission to a hospital and requires surveillance by an experienced team. As a non-invasive alternative diagnosis procedure, coronary computed tomographic angiography has showed promising performance with high negative predictive value (95%-100%). Furthermore, computed tomography is a noninvasive procedure with low risk and cost, and it can be easily performed at the clinic. Except for evaluation of coronary artery, computed tomography can also provide information of lung, mediastinum and cardiac structure, which may help physicians make early diagnosis and treatment. Computed tomography is not routinely utilized in clinical practice.

Our study is a prospective multicenter study to assess the feasibility and safety of adding computed tomography as a gatekeeper and perform invasive coronary angiography selectively prior to valvular surgeries.

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
40 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male ≥ 40 years old; postmenopausal female;
  • Patients scheduled to undergo valvular replacement or repair;
  • Patients providing written informed consent;

排除标准

  • Patients with definite coronary artery disease history (Prior myocardial infarction, percutaneous coronary intervention or CABG);
  • Patients with objective evidence of myocardial ischemia;
  • Underwent CTA or ICA in 6 months;
  • With contraindications to CTA/ICA (allergic to contrast medium, peripheral arterial occlusive disease, chronic kidney disease with estimated glomerular filtration rate (eGFR) less than 15ml/min.1.73m2 )

结局指标

主要结局

Incidence of cardiovascular complications and mortality [Perioperative Safety]

时间窗: POD 30 days

Incidence rates of intraoperative and postoperative cardiovascular complications and mortality caused by coronary stenosis within 30 days after the surgery will be compared between the two groups.

次要结局

  • Effectiveness of the coronary artery evaluation protocol(24h after the operation)

研究者

发起方
Chinese Academy of Medical Sciences, Fuwai Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bin Lu

Professor

Chinese Academy of Medical Sciences, Fuwai Hospital

研究点 (5)

Loading locations...

相似试验