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

NCT06793774 | Recruiting

• 1 other identifier: 2022YFC2533502-3
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, prospective cohort study. This study is designed to accurately analyze coronary artery plaque characteristics and local hemodynamic parameters in patients diagnosed with chronic coronary syndrome (CCS) or non-ST-segment elevation acute coronary syndrome (NSTE-ACS), with marginal lesions or obstructive lesions in major coronary arteries by multimodality imaging including noninvasive coronary CT angiography (CCTA) and intracoronary imaging techniques, such as intravascular ultrasound (IVUS), optical coherence tomography (OCT), and near infrared spectroscopy (NIRS). The purpose of this study is to improve the accuracy and depth of plaque analysis by CCTA under the guidance of intracoronary imaging, therefore constructing a new CCTA-based high-risk plaque model.

Conditions

Coronary Artery Disease; Coronary Atheroscleroses; Acute Coronary Syndromes (ACS)

Keywords

coronary CT angiography; intracoronary imaging; coronary optical coherence tomography

Outcome Measures

Primary Outcomes (1)

• Prediction performance of high-risk plaques by CCTA

  By using intracoronary imaging as the 'gold standard', the new CCTA model generated by machine learning will be compared with traditional CCTA models in the prediction performance of high-risk plaques (area under receiver operating characteristics curve, etc.)

  2 Years

Secondary Outcomes (4)

• Major cardiovascular events (MACEs)

  2 years

• Cardiovascular death

  2 years

• Myocardial infarction

  2 years

• Unplanned revascularization

  2 years

Study Arms (1)

Study cohort

Patients with CCS or NSTE-ACS, who receive CCTA scan showing marginal or obstructive lesions (DS 40%-90%), are then referred to invasive coronary angiography with intracoronary imaging examination, such as IVUS, OCT, NIRS, within 1 month

Eligibility Criteria

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

Study Population

This cohort includes patients with coronary artery disease as detected by computed tomography angiography (CCTA), and was planned to receive coronary angiography.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples without DNA analysis were obtained for further proteomic study to discover the association with high risk plaques. (See RECONGNIZE-IV study)

MeSH Terms

Conditions

Coronary Artery Disease; Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

• Ruiyan Zhang, M.D., Ph.D.

  Ruijin Hospital

  STUDY DIRECTOR

Central Study Contacts

Xiaoqun Wang, M.D., Ph.D.

CONTACT

+86 21 64370045; xiaoqun_wang@hotmail.com

Shuo Feng, M.D., Ph.D.

CONTACT

+86 21 64370045; fengshuorv@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cardiology, Director of cardiovascular catherization lab, Principle Investigator

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: January 27, 2025
• Study Start: July 1, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 27, 2025

Record last verified: 2025-01

Locations

CN (1)