跳至主要内容
临床试验/NCT05124249
NCT05124249招募中不适用

Imaging and Physiologic Evaluation of Coronary Artery Disease: a Prospective Registry Study (IP-CAD)

Chonnam National University Hospital1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2021年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
2,000
试验地点
1
主要终点
MACE

研究概览

简要总结

To evaluate the long-term clinical outcomes and prognostic factors in patients with coronary artery disease (CAD) undergoing invasive coronary angiography (ICA), intravascular imaging, or invasive physiologic assessment.

详细描述

The traditional standard method for evaluating coronary artery disease (CAD) is invasive coronary angiography (ICA). ICA enables the assessment of anatomic severity of the epicardial artery and the severity of diameter stenosis can be closely associated with myocardial ischemia. However, there remains concern that anatomical severity is not always identical with functional significance. Actually, even the patients showed positive non-invasive tests including treadmill test, stress echocardiography, coronary computed tomography angiography, or nuclear imaging, less than half of the patients showed significant stenosis on ICA. Therefore, the investigators need further investigation to overcome the limitations of ICA.

In this regard, intravascular imaging, such as intravascular ultrasound (IVUS) and optical coherence tomography (OCT), is a useful tool for assessing the anatomical severity in more detail. Those imaging modalities produce cross-sectional images of CAD and imaging modalities are allowing to assess lesion characteristics, plaque morphology, treatment planning, and optimization of the implanted stent. Furthermore, imaging-guided percutaneous coronary intervention (PCI) has been shown favorable outcomes, compared with angiography only-guided PCI, especially in complex lesions. Meanwhile, there has been an ample body of evidence that invasive coronary physiology assessment, such as fractional flow reserve (FFR), also can be useful for assessing the functional significance. Therefore, the current guidelines have continuously recommended intracoronary imaging and invasive physiologic assessment for guiding the treatment of CAD.

The aim of the IP-CAD (Imaging and Physiologic Evaluation of Coronary Artery Disease: a Prospective Registry Study) is to evaluate the long-term clinical outcomes according to the imaging-guided or physiology-guided PCI in real-world practice.

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

  • Subject must be at least 18 years of age
  • Subjects who suspected ischemic heart disease and underwent ICA.
  • Subjects who were performed intravascular imaging or invasive physiologic assessment

排除标准

  • Subject with Age <18 years
  • Pregnant women

研究组 & 干预措施

Invasive coronary angiography (ICA)

Patients who undergoing invasive coronary angiography with intravascular imaging or invasive physiologic assessment

干预措施: Intravascular imaging (IVUS or OCT) or Invasive physiologic assessment (Diagnostic Test)

Percutaneous coronary intervention (PCI)

Patients who undergoing percutaneous coronary intervention with intravascular imaging or invasive physiologic assessment

干预措施: Intravascular imaging (IVUS or OCT) or Invasive physiologic assessment (Diagnostic Test)

Percutaneous coronary intervention (PCI)

Patients who undergoing percutaneous coronary intervention with intravascular imaging or invasive physiologic assessment

干预措施: PCI (Procedure)

结局指标

主要结局

MACE

时间窗: 3-Year after the index procedure

a composite of all-cause death, myocardial infarction, or any revascularization

次要结局

  • MACCE(3-Year after the index procedure)
  • Rate of ischemic or hemorrhagic stroke(3-Year after the index procedure)
  • Rate of target lesion revascularization(3-Year after the index procedure)
  • Rate of cardiac death(3-Year after the index procedure)
  • Rate of stent thrombosis(3-Year after the index procedure)
  • Rate of all-cause death(3-Year after the index procedure)
  • Rate of myocardial infarction(3-Year after the index procedure)
  • Rate of target vessel revascularization(3-Year after the index procedure)
  • Rate of any revascularization(3-Year after the index procedure)
  • Rate of BARC type 2,3, or 5 bleeding(3-Year after the index procedure)

研究者

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

Young Joon Hong

Professor

Chonnam National University Hospital

研究点 (1)

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