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Search / Trial NCT06793787

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

Launched by RUIJIN HOSPITAL · Jan 21, 2025

Trial Information

Current as of July 09, 2025

Recruiting

Keywords

Acute Coronary Syndrome Chronic Coronary Syndrome Coronary Vulnerable Plaque Intracoronary Imaging Coronary Ct Angiography

ClinConnect Summary

This clinical trial is investigating new blood markers to help predict which patients with coronary artery disease are at higher risk for serious heart problems. The study focuses on patients who have chronic coronary syndrome or certain types of acute coronary syndromes and have specific findings from heart imaging tests. If you or a family member are at least 18 years old and have been diagnosed with these conditions, you may be eligible to participate, especially if your heart tests show certain types of blockages.

Participants in the trial will undergo various heart imaging procedures and provide blood samples. They will be followed up every three months for two years to see if the new biomarkers can help identify those at risk for major heart events. This research aims to improve early detection and treatment for heart disease, ultimately helping to save lives. If you're interested in participating or have any questions, it’s a great idea to talk to your healthcare provider for more information.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Age ≥ 18 years
  • Patients with CCS or NSTE-ACS
  • Receive CCTA scan or ICA, with marginal lesions (DS between 40%-69%) or obstructive lesions (DS ≥70% or CT-FFR/FFR \<0.8) in major coronary arteries
  • Receive invasive coronary angiography and OCT, with or without other intracoronary imaging techniques such as IVUS and NIRS
  • Exclusion Criteria:
  • 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