Analyzing plaque types in coronary artery disease using advanced imaging and immune profiling

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

This study is testing how different types of plaque in the arteries affect heart disease by using advanced imaging and immune cell analysis to help improve patient care.

Quick facts

• Study type: Observational
• Enrollment: 350 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Harbin Medical University (Academic / other)
• Locations: 2 sites (Harbin, Heilongjiang and 1 other locations)
• Trial ID: NCT06489119 on ClinicalTrials.gov

What this trial studies

The MOOP-CAD program investigates the progression of coronary atherosclerotic plaques by integrating in vivo imaging techniques, specifically optical coherence tomography (OCT), with single-cell multi-omics analysis of circulating immune cells. This observational study aims to correlate the imaging characteristics of coronary plaques with their molecular and immune profiles, providing insights into the pathophysiological processes involved in coronary artery disease. By examining different plaque subtypes, the study seeks to enhance understanding of plaque behavior and its implications for patient management.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 85 with varying degrees of coronary artery stenosis, particularly those with stable, vulnerable, or ruptured plaques.

Not a fit: Patients with coronary angiographic diameter stenosis less than 30% may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved diagnostic and therapeutic strategies for patients with coronary artery disease.

How similar studies have performed: While this approach is innovative, similar studies utilizing multi-omics in cardiovascular research have shown promising results, indicating potential for success.

Eligibility criteria

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.

Where this trial is running

Harbin, Heilongjiang and 1 other locations

• The Second Affiliated Hospital of Harbin Medical University — Harbin, Heilongjiang, China (Recruiting)
• China-Japan Union Hospital of Jilin — Changchun, Jilin, China (Recruiting)

Study contacts

• Study coordinator: Bo Yu, MD,PhD

Conditions Coronary Artery Disease; Coronary atherosclerosis; Optical coherence tomography; Multi-omics