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NCT07262359
Intravascular Imaging Evaluated Calcified Nodule China Registry
trial in Coronary Artery Disease in 500 participants. Not yet recruiting.
1 December 2030
Quick facts
| Lead sponsor | Shanghai Zhongshan Hospital |
|---|---|
| Status | Not yet recruiting |
| Study type | OBSERVATIONAL |
| Enrollment | 500 |
| Start date | 1 December 2025 |
| Primary completion | 1 December 2030 |
| Estimated completion | 1 December 2031 |
Conditions studied
- Coronary Artery Disease — all drugs for Coronary Artery Disease →
- Coronary Artery Atherosclerosis — all drugs for Coronary Artery Atherosclerosis →
- Coronary Calcified Nodules — all drugs for Coronary Calcified Nodules →
- Coronary Calcification — all drugs for Coronary Calcification →
Sponsor
Shanghai Zhongshan Hospital
Who can join
18 and older, any sex, with Coronary Artery Disease or Coronary Artery Atherosclerosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07262359
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07262359 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shanghai Zhongshan Hospital
- Last refreshed: 3 December 2025
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing