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

NCT06793787 | Recruiting

• 1 other identifier: 2022YFC2533502-4
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a single-center, prospective cohort study. The study is designed to identify novel circulating biomarkers for early prediction of high-risk coronary plaques. 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 detected by noninvasive coronary CT angiography (CCTA) or invasive coronary angiography (ICA), will be consecutively enrolled. Optical coherence tomography (OCT), with or without other intracoronary imaging modalities such as intravascular ultrasound (IVUS) and near infrared spectroscopy (NIRS), will be performed. Liquid chromatography-mass spectrometry (LC-MS/MS), bioinformatic analysis, and machine learning methods will be performed to characterize plasma proteomic profiles. The cohort will be followed-up every 3 months for 2 years. The association of novel biomarkers with the occurrence of major adverse cardiovascular events (MACEs) will be examined.

Conditions

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

Keywords

Acute coronary syndrome; Chronic coronary syndrome; Coronary vulnerable plaque; intracoronary imaging; coronary CT angiography

Outcome Measures

Primary Outcomes (1)

• Prediction performance of high-risk plaques by novel biomarkers

  The prediction performance of high-risk plaques (area under receiver operating characteristics curve, etc.) by novel biomarkers will be compared with traditional risk factors.

  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)

Cornary plaque analysis group

Patients with CCS or NSTE-ACS, who have marginal or obstructive lesions (DS 40% - 90%) detected by CCTA or ICA, will be consecutively enrolled. OCT, with or without other intracoronary imaging modalities including IVUS and NIRS, will be performed to classify plaque types and precisely measure plaque burden and other geometric parameters. Plasma samples will be collected on the day of angiography in all patients after overnight fasting.

Eligibility Criteria

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

Study Population

Patients diagnosed with chronic coronary syndrome (CCS) or non-ST-segment elevation acute coronary syndrome (NSTE-ACS), with marginal lesions (diameter stenosis \[DS\] between 40%-69%) or obstructive lesions (DS ≥70% or CT-FFR/FFR \<0.8) in major coronary arteries detected by noninvasive coronary CT angiography (CCTA) or invasive coronary angiography (ICA), will be consecutively enrolled.

You may qualify if:

• 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

You may not qualify if:

• 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 collected at the same time of the coronary imaging.

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

Xiao Qun 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: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cardiology, Director of cardiovascular catherization lab, Principle Investigator Affiliation: Ruijin Hospital

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)