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NCT Number: NCT06489119

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

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Second Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Plaque rupture was defined by the presence of a discontinuity of the fibrous cap with a cavity formed inside the plaque.

Plaque erosion 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.
  • 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

  • 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.

Treatment and study plan

Primary outcomes

  1. Incidence of MACE

    Time frame: 1 year following hospital discharge

    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)

Secondary outcomes

  1. Incidence of SCD

    Time frame: 1 year following hospital discharge

    The incidence of sudden cardiac death in patients

  2. Incidence of nonfatal myocardial infarction

    Time frame: 1 year following hospital discharge

    The incidence of nonfatal myocardial infarction in patients

  3. Incidence of target vessel revascularization

    Time frame: 1 year following hospital discharge

    The incidence of target vessel revascularization in patients

Study contacts

Contact information is provided by the study sponsor or research team.

Bo Yu, MD,PhD

CONTACT

[email protected]

86-045186605180

Maomao Zhang, MD,PhD

CONTACT

[email protected]

15145106466

Sponsors and collaborators

Lead sponsor

Harbin Medical University

Other

Registry information

Official study title

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

Acronym: MOOP-CAD

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 5, 2024
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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