Single-cell Multi-omics Analyses of OCT-diagnosed Plaque Subtypes in Coronary Artery Disease (MOOP-CAD) (MOOP-CAD)

Single-cell Multi-omics Analyses of OCT-diagnosed Plaque Subtypes in Coronary Artery Disease - a Prospective, Observational Study

The MOOP-CAD study program characterizes, for the first time, the pathophysiological processes and molecular mechanisms of coronary atherosclerotic plaque progression by combining in vivo intravascular imaging techniques with circulating immune single-cell multi-omics analysis. In this study, the investigators evaluate the imaging characteristics of coronary plaques by optical coherence tomography (OCT) and invasive angiography, and study the correlation between plaque characteristics and the multi-omics immune characteristic profiles.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease

• Study Type: Observational
• Enrollment (Estimated): 350

Contacts and Locations

• Study Contact: Name: Bo Yu, MD,PhD; Phone Number: 86-045186605180; Email: yubodr@163.com
• Study Contact Backup: Name: Maomao Zhang, MD,PhD; Phone Number: 15145106466; Email: maomaolp1983@163.com

Study Locations

• China
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150081
      • Recruiting
      • The Second Affiliated Hospital of Harbin Medical University
      • Principal Investigator: Bo Yu, MD,PhD
      • Contact: Bo Yu, MD,PhD; Phone Number: 86-045186605180; Email: yubodr@163.com
      • Principal Investigator: Jingbo Hou, MD,PhD
      • Principal Investigator: Maomao Zhang, MD,PhD
      • Principal Investigator: Jiannan Dai, MD,PhD
  • Jilin
    • Changchun, Jilin, China, 130033
      • Recruiting
      • China-Japan Union Hospital of Jilin
      • Principal Investigator: Yuquan He, MD,PhD
      • Contact: Yuquan He, MD,PhD; Phone Number: 86-043184645407; Email: heyq@jlu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Subjects who meet the preset inclusion criteria for each group of people, understand the research requirements and treatment procedures, and sign the informed consent.

Description

Inclusion Criteria:

1. Male or female, Age ≥ 18 years and ≤ 85 years.
2. Ability to understand the requirements of the study and to provide informed consent.

Control group:

Patients with coronary angiographic diameter stenosis <20%.

Stable plaque group:

1. Have been clinically stable for at least 6 months.
2. Presence of ≥1 lesion with angiographic diameter stenosis >50% with no TCFA lesions in the most severely narrowed native coronary artery (target vessel). TCFA was defined as a lipidic plaque with the thinnest FCT <75 mm and maximum lipid arc >180°.
3. Rule out elevation of troponin or myocardial enzymology.

Vulnerable plaque group:

1. Have been clinically stable for at least 6 months.
2. Presence of ≥1 lesion with angiographic diameter stenosis >50% with TCFA lesions in the most severely narrowed native coronary artery (target vessel).
3. Rule out elevation of troponin or myocardial enzymology.

Plaque rupture group:

1. Persistent chest pain for 30 minutes, arrival at the hospital within 24 hours from symptom onset. ST-segment elevation of >0.1 mV in ≥2 contiguous leads or new-onset left bundle branch block, and high sensitive Troponin T or I or CK/CK-MB above upper reference value.
2. Exist clearly identified culprit lesion.
3. Plaque rupture was defined by the presence of a discontinuity of the fibrous cap with a cavity formed inside the plaque.

Plaque erosion group:

1. Persistent chest pain for 30 minutes, arrival at the hospital within 24 hours from symptom onset. ST-segment elevation of >0.1 mV in ≥2 contiguous leads or new-onset left bundle branch block, and high sensitive Troponin T or I or CK/CK-MB above upper reference value.
2. Exist clearly identified culprit lesion.
3. Plaque erosion was defined by the presence of the attached thrombus overlying the intact fibrous cap of the atherosclerotic plaque, luminal surface irregularity at the culprit lesion in the absence of thrombus, or attenuation of the underlying plaque by thrombus without superficial lipid or calcium at the site of the thrombus.

Exclusion Criteria:

1. Cardiogenic shock or circulatory depression，life-threatening arrhythmia.
2. Known systolic heart failure with LVEF ≤30%.
3. Severe systemic diseases (end-stage renal disease, serious liver dysfunction, chronic active inflammatory diseases, active oncologic diseases, autoimmune diseases).
4. Septicemia, acute inflammatory event with fever.
5. Patients with organ transplants or patients on the waiting list for an organ transplant.
6. Previous CABG treatment, PCI treatment of the target vessel, and PCI treatment of non-target vessels within 1 year.
7. Thrombolysis before PCI.
8. Stenosis of the left main artery ≥50%.
9. Characteristics rendering high-quality OCT imaging unlikely such as chronic total occlusion, pronounced tortuosity, heavily calcified vessels.
10. Infarcted vessel with a diameter >4mm or <2.5mm.
11. "No-reflow" (TIMI 0-1) after thrombus aspiration or predilatation.
12. Other subjects deemed unsuitable for study by investigators.

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort
Plaque rupture group; Patient diagnosed as AMI with plaque rupture detected by OCT.
Plaque erosion group; Patient diagnosed as AMI with plaque erosion detected by OCT.
Control group; Patients with angiographic diameter stenosis <20%
Stable plaque group; Angiographic diameter stenosis >50% with no TCFA lesions in the most severely narrowed native coronary artery (target vessel).
Vulnerable plaque group; Angiographic diameter stenosis >50% with TCFA lesions in the most severely narrowed native coronary artery (target vessel).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of MACE	The incidence of major adverse cardiovascular events in patients (Major adverse cardiovascular events is defined as the composite of all-cause death, recurrent myocardial infarction, revascularization, unplanned readmission for angina exacerbation or unstable angina)	1 year following hospital discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of SCD	The incidence of sudden cardiac death in patients	1 year following hospital discharge
Incidence of nonfatal myocardial infarction	The incidence of nonfatal myocardial infarction in patients	1 year following hospital discharge
Incidence of target vessel revascularization	The incidence of target vessel revascularization in patients	1 year following hospital discharge

Collaborators and Investigators

• Sponsor: Harbin Medical University

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2024
• Primary Completion (Estimated): January 15, 2026
• Study Completion (Estimated): July 15, 2026

Study Registration Dates

• First Submitted: June 17, 2024
• First Submitted That Met QC Criteria: July 4, 2024
• First Posted (Actual): July 5, 2024

Study Record Updates

• Last Update Posted (Estimated): September 15, 2025
• Last Update Submitted That Met QC Criteria: September 9, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Optical coherence tomography; Multi-omics; Coronary atherosclerosis
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease
• Other Study ID Numbers: KY2024-084

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No