NCT07262359Not yet recruiting
Intravascular Imaging Evaluated Calcified Nodule China Registry
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)
Source: ClinicalTrials.gov · Last updated 3 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 500 (estimated)
- First submitted
- 29 Sept 2025
- Start date
- 1 Dec 2025
- Primary completion date
- 1 Dec 2030
- Lead sponsor
- Shanghai Zhongshan Hospital
- Diseases
- Coronary artery disease
- NCT number
- NCT07262359
What you commit to
- Study type: Observational
- Planned participants: 500
- From 1 Dec 2025 to the primary completion date, 1 Dec 2030
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Life Expectancy: Life expectancy of less than 1 year due to non-cardiac comorbid conditions (e.g., active malignancy, advanced organ failure).
Other
- Inability to Follow-Up: Inability or unwillingness to comply with the study protocol or scheduled follow-up visits.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.