A Multi-Center, Prospective, Observational Registry for the Evaluation of Coronary Artery Calcified Nodules Using Intravascular Ultrasound (IVUS) and/or Optical Coherence Tomography (OCT) in China (CN-IVI Registry)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 500
- 主要终点
- Target lesion failure
研究概览
简要总结
What is this study about? This is a nationwide research study in China focused on understanding a specific type of challenging plaque in heart arteries called a Calcified Nodule (CN). The study will use advanced imaging technology inside the blood vessels to see these nodules in great detail, track how they are treated, and see how patients do in the long term.
Why is this important? Calcified nodules are hard, bony-like plaques that can cause sudden heart attacks. They are difficult to treat with standard procedures like stenting because they are rigid and can be unpredictable. This registry aims to create a large database of real-world cases to help doctors better understand how to identify and manage CNs effectively, ultimately improving patient care and outcomes across China.
What are IVUS and OCT? These are sophisticated imaging tools that doctors use during a heart catheterization. Think of them like a "GPS" or an "ultrasound" for the inside of your arteries.
IVUS (Intravascular Ultrasound): Uses sound waves to create a detailed, 360-degree picture of the artery wall. It shows the size of the plaque and how deep it goes, helping doctors choose the right size stent.
OCT (Optical Coherence Tomography): Uses light waves to create extremely high-resolution images, like a microscope inside the artery. It is excellent for seeing the precise surface and structure of a calcified nodule.
Together, these tools give doctors a clear view of the problem, which is crucial for planning the best treatment strategy.
What will the study do?
The registry will collect anonymous data from participating hospitals across China. Researchers will analyze:
How common calcified nodules are in Chinese patients.
The best ways to use IVUS and OCT to identify and characterize CNs.
Which treatment techniques (e.g., special balloons, atherectomy) work best.
The long-term results for patients who receive stents to treat a CN.
Who is this for?
Patients & Families: To understand that advanced care and research are being dedicated to complex heart conditions. Participation (if eligible) contributes to medical knowledge that may help future patients.
Healthcare Providers: To provide a standardized, large-scale analysis of CNs, leading to improved diagnosis, treatment guidelines, and procedural techniques for this complex lesion.
This registry represents a significant step forward in personalized cardiac care in China, using cutting-edge technology to solve a difficult clinical problem.
详细描述
- Study Title and Overview
Official Title: A Multi-Center, Prospective, Observational Registry for the Evaluation of Coronary Artery Calcified Nodules Using Intravascular Ultrasound (IVUS) and/or Optical Coherence Tomography (OCT) in China (CN-IVI Registry)
Overview: The CN-IVI Registry is a large-scale, observational study conducted across multiple leading cardiac centers in China. Its primary purpose is to systematically investigate a specific, complex, and high-risk type of coronary plaque known as a Calcified Nodule (CN). By leveraging advanced intracoronary imaging techniques, IVUS and/or OCT, the registry aims to create a robust database to improve the diagnosis, characterization, treatment, and long-term outcomes for patients with this challenging lesion. 2. Background and Rationale: Why Focus on Calcified Nodules?
Coronary artery disease (CAD) involves the buildup of plaque inside the heart's arteries. While there are several types of plaque, Calcified Nodules are among the most complex and dangerous.
What is a Calcified Nodule? A CN is a specific type of plaque characterized by a sharp, protruding, and often fractured nodule of calcium that erupts through the artery's inner lining (intima). This creates a irregular, bony surface within the blood vessel that is highly thrombogenic (likely to cause blood clots) and is a known cause of sudden acute coronary syndromes (heart attacks).
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
- 否
入选标准
- •The patient must be at least 18 years old.
- •Intracoronary imaging confirms the presence of at least one calcified nodule lesion.
- •The patient is willing and able to comply with the study procedures and follow-up until the study concludes.
- •The subject confirms understanding of the study's risks, benefits, and alternative treatments, and has signed the informed consent form approved by the ethics committee prior to any protocol-related procedures.
排除标准
- •Contraindication to Procedure: Known contraindication to coronary angiography, PCI, or adjunctive pharmacologic therapy (e.g., aspirin, P2Y12 inhibitors, heparin, contrast media) that cannot be adequately managed with standard medical care.
- •Life Expectancy: Life expectancy of less than 1 year due to non-cardiac comorbid conditions (e.g., active malignancy, advanced organ failure).
- •Inability to Follow-Up: Inability or unwillingness to comply with the study protocol or scheduled follow-up visits.
结局指标
主要结局
Target lesion failure
时间窗: 3 years
including A composite of cardiac death, target vessel myocardial infarction, and clinically-driven target lesion revascularization
次要结局
未报告次要终点