Intravascular Imaging Evaluated Calcified Nodule China Registry

NCT07262359 | Not Yet Recruiting DMC

• 1 other identifier: CN-IVI Registry
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Coronary Artery Disease; Coronary Artery Atherosclerosis; Coronary Calcified Nodules; Coronary Calcification

Keywords

coronary artery disease; coronary calcification; coronary calcified nodules; optical coherence tomography; intravascular ultrosound

Outcome Measures

Primary Outcomes (1)

• Target lesion failure

  including A composite of cardiac death, target vessel myocardial infarction, and clinically-driven target lesion revascularization

  3 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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:

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead
• The First Hospital of Jilin University: collaborator
• Zhongnan Hospital: collaborator
• Fu Wai Hospital, Beijing, China: collaborator

Related Publications (7)

• Zhang M, Matsumura M, Usui E, Noguchi M, Fujimura T, Fall KN, Zhang Z, Nazif TM, Parikh SA, Rabbani LE, Kirtane AJ, Collins MB, Leon MB, Moses JW, Karmpaliotis D, Ali ZA, Mintz GS, Maehara A. Intravascular Ultrasound-Derived Calcium Score to Predict Stent Expansion in Severely Calcified Lesions. Circ Cardiovasc Interv. 2021 Oct;14(10):e010296. doi: 10.1161/CIRCINTERVENTIONS.120.010296. Epub 2021 Oct 19.

  PMID: 34665658 BACKGROUND

• Sato T, Yamamoto K, Matsumura M, Shlofmitz E, Khalique OK, Mintz GS, Shlofmitz RA, Jeremias A, Ali ZA, Maehara A. Discrimination of Calcified Nodule as a Cause of Coronary Angiographic Radiolucent Mass. JACC Cardiovasc Interv. 2023 Aug 14;16(15):1948-1949. doi: 10.1016/j.jcin.2023.04.013. Epub 2023 Jul 5. No abstract available.

  PMID: 37409997 BACKGROUND

• Sato T, Matsumura M, Yamamoto K, Shlofmitz E, Moses JW, Khalique OK, Thomas SV, Tsoulios A, Cohen DJ, Mintz GS, Shlofmitz RA, Jeremias A, Ali ZA, Maehara A. Impact of Eruptive vs Noneruptive Calcified Nodule Morphology on Acute and Long-Term Outcomes After Stenting. JACC Cardiovasc Interv. 2023 May 8;16(9):1024-1035. doi: 10.1016/j.jcin.2023.03.009.

  PMID: 37164599 BACKGROUND

• Hada M, Kakuta T, Sugiyama T, Hoshino M, Yonetsu T, Usui E, Hanyu Y, Nagamine T, Nogami K, Ueno H, Matsuda K, Sayama K, Setoguchi M, Tahara T, Sakamoto T, Mineo T, Kobayashi N, Takano M, Kondo S, Wakabayashi K, Suwa S, Dohi T, Mori H, Kimura S, Mitomo S, Nakamura S, Higuma T, Yamaguchi J, Natsumeda M, Ikari Y, Yamashita J, Mizukami T, Yamamoto MH, Sasano T, Shinke T; TACTICS Investigators. Prognostic Impact of Culprit Lesion Calcified Nodule After Emergency Coronary Intervention: A TACTICS Registry Subanalysis. JACC Cardiovasc Imaging. 2024 Nov;17(11):1384-1386. doi: 10.1016/j.jcmg.2024.06.010. Epub 2024 Aug 7. No abstract available.

  PMID: 39115502 BACKGROUND

• Madhavan MV, Alsaloum M, Maehara A, Gogia S, Lee J, Fall K, Prasad M, McEntegart MB, Kirtane AJ. Recurrent Calcified Nodule Protrusion Through Stent Struts After Percutaneous Coronary Intervention of the RCA. JACC Cardiovasc Interv. 2023 Oct 9;16(19):2463-2465. doi: 10.1016/j.jcin.2023.07.033. Epub 2023 Sep 6. No abstract available.

  PMID: 37676224 BACKGROUND

• Brott BC. The Calcified Nodule Paradox. JACC Cardiovasc Interv. 2023 May 8;16(9):1036-1038. doi: 10.1016/j.jcin.2023.04.001. No abstract available.

  PMID: 37164600 BACKGROUND

• Shin D, Karimi Galougahi K, Spratt JC, Maehara A, Collet C, Barbato E, Ribichini FL, Gonzalo N, Sakai K, Mintz GS, Stone GW, Shlofmitz E, Shlofmitz RA, Jeremias A, Ali ZA. Calcified Nodule in Percutaneous Coronary Intervention: Therapeutic Challenges. JACC Cardiovasc Interv. 2024 May 27;17(10):1187-1199. doi: 10.1016/j.jcin.2024.03.032.

  PMID: 38811101 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Junbo Ge, M.D., Ph.D.

CONTACT

8613816767665; gbge@zs-hospital.sh.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2025
• First Posted: December 3, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2031
• Last Updated: December 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share