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

NCT06489119 | Recruiting

• 1 other identifier: KY2024-084
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Coronary Artery Disease

Keywords

Coronary atherosclerosis; Optical coherence tomography; Multi-omics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Incidence of SCD

  1 year following hospital discharge

• Incidence of nonfatal myocardial infarction

  1 year following hospital discharge

• Incidence of target vessel revascularization

  1 year following hospital discharge

Study Arms (5)

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).

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.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Male or female, Age ≥ 18 years and ≤ 85 years.
• 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:
• Have been clinically stable for at least 6 months.
• 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°.
• Rule out elevation of troponin or myocardial enzymology.
• Vulnerable plaque group:
• Have been clinically stable for at least 6 months.
• Presence of ≥1 lesion with angiographic diameter stenosis \>50% with TCFA lesions in the most severely narrowed native coronary artery (target vessel).
• Rule out elevation of troponin or myocardial enzymology.
• Plaque rupture group:
• 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.
• Exist clearly identified culprit lesion.

You may not qualify if:

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

Sponsors & Collaborators

• Harbin Medical University: lead

Study Sites (2)

The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150081, China

RECRUITING

China-Japan Union Hospital of Jilin

Changchun, Jilin, 130033, China

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Bo Yu, MD,PhD

CONTACT

86-045186605180; yubodr@163.com

Maomao Zhang, MD,PhD

CONTACT

15145106466; maomaolp1983@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Cardiology

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: July 5, 2024
• Study Start: July 7, 2024
• Primary Completion: January 15, 2026
• Study Completion: July 15, 2026
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)