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.
The patient must be at least 18 years old.
None
Age: ≥ 18 years old. Clinical Presentation: Patient presents with stable coronary artery disease, unstable angina, or an acute coronary syndrome (including NSTEMI and STEMI) and is scheduled to undergo coronary angiography and percutaneous coronary intervention (PCI). Intravascular Imaging Indication: The use of intravascular imaging (IVUS or OCT) is clinically indicated and used during the PCI procedure at the discretion of the operating interventional cardiologist. Common clinical indications include: Assessment of lesion severity and morphology. Guidance for stent sizing and optimization. Evaluation of complex lesions (e.g., calcified, long, bifurcation lesions). Target Lesion Identification: The use of IVUS or OCT must identify the presence of a calcified nodule (CN) in at least one native coronary artery lesion. The CN must be confirmed by the core lab according to standardized definitions:
Cohort
Prospective
Not listed
Target lesion failure
including A composite of cardiac death, target vessel myocardial infarction, and clinically-driven target lesion revascularization
Click on the lead sponsor to view all of their trials.
Shanghai Zhongshan Hospital
Lead sponsor
The First Hospital of Jilin University
Collaborator
Zhongnan Hospital
Collaborator
Fu Wai Hospital, Beijing, China
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
