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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: yubodr@163.com
• Phone: 86-045186605180

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.