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Search / Trial NCT06793774

Risk Evaluation by COronary Imaging and Artificial intelliGence Based fuNctIonal analyZing tEchniques - III

Launched by RUIJIN HOSPITAL · Jan 21, 2025

Trial Information

Current as of July 09, 2025

Recruiting

Keywords

Coronary Ct Angiography Intracoronary Imaging Coronary Optical Coherence Tomography

ClinConnect Summary

The clinical trial titled "Risk Evaluation by COronary Imaging and Artificial intelliGence Based fuNctIonal analyZing tEchniques - III" is studying ways to better understand coronary artery disease, which occurs when plaque builds up in the arteries of the heart. This study aims to use advanced imaging techniques to analyze the characteristics of these plaques in patients who have chronic coronary syndrome or a type of acute coronary syndrome. By combining different imaging methods, the researchers hope to create a new model that can more accurately identify high-risk plaques that could lead to serious heart issues.

To be eligible for this trial, participants need to be at least 18 years old and diagnosed with specific heart conditions. They must undergo a coronary CT scan, which looks for certain types of blockages in the major arteries. Participants will also need to have additional imaging tests within a month after the CT scan. Those who have serious kidney issues, have had recent heart procedures, or certain other health conditions may not qualify. If you decide to join, you can expect to undergo several non-invasive imaging tests to help improve our understanding of heart disease and how to better treat it.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Age ≥ 18 years
  • Patients with CCS or NSTE-ACS
  • Receive CCTA scan, with marginal lesions (DS between 40%-69%) or obstructive lesions (DS ≥70% or CT-FFR \<0.8) in major coronary arteries
  • Receive invasive coronary angiography and intracoronary imaging examination, including IVUS, OCT, NIRS, within 1 month after CCTA
  • Exclusion Criteria:
  • Unsuitable for CCTA (such as severe renal impairment, uncontrolled thyroid condition, allergic to iodine, etc.)
  • Receive percutaneous coronary intervention (PCI) within 6 months
  • Prior history of myocardial infarction or heart failure
  • Prior history of coronary artery bypass graft (CABG)
  • Abnormal liver function (serum alanine aminotransferase \[ALT\] level exceeding 3 times the upper limit of normal) or abnormal kidney function (eGFR ≤30%)
  • Familial hypercholesterolemia
  • Estimated survival ≤ 1 year
  • Malignant tumor
  • Pregnant or lactation, or have the intention to give birth within one year
  • Poor compliance, unable to follow-up

About Ruijin Hospital

Ruijin Hospital, affiliated with Shanghai Jiao Tong University School of Medicine, is a leading medical institution in China recognized for its commitment to advancing healthcare through innovative research and clinical trials. With a strong emphasis on patient-centered care, Ruijin Hospital integrates cutting-edge medical practices with rigorous scientific investigation. The hospital's multidisciplinary teams are dedicated to developing new therapeutic approaches, improving patient outcomes, and contributing to global medical knowledge. As a sponsor of clinical trials, Ruijin Hospital ensures adherence to the highest ethical standards and regulatory compliance, fostering an environment of collaboration and excellence in clinical research.

Locations

Shanghai, Shanghai, China

Patients applied

0 patients applied

Trial Officials

Ruiyan Zhang, M.D., Ph.D.

Study Director

Ruijin Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported