Coronary Artery DiseaseMOOP-CADNCT06489119
Single-cell Multi-omics Analyses of OCT-diagnosed Plaque Subtypes in Coronary Artery Disease (MOOP-CAD)
An observational study of Coronary Artery Disease, run by Harbin Medical University at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 350 participants
- Where
- 2 sitesChina
- Study dates
- 7 Jul 2024to 15 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
China-Japan Union Hospital of Jilin
Changchun, Jilin, 130033
Yuquan He, MD,PhD, 86-043184645407, heyq@jlu.edu.cn
Yuquan He, MD,PhD
- Recruiting
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150081
Bo Yu, MD,PhD, 86-045186605180, yubodr@163.com
Bo Yu, MD,PhD
About this study
Official title: 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.
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary atherosclerosis, Optical coherence tomography, Multi-omics
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 year following hospital discharge
Secondary outcomes (3)
Incidence of SCD
The incidence of sudden cardiac death in patients
Measured: 1 year following hospital discharge
Incidence of nonfatal myocardial infarction
The incidence of nonfatal myocardial infarction in patients
Measured: 1 year following hospital discharge
Incidence of target vessel revascularization
The incidence of target vessel revascularization in patients
Measured: 1 year following hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start7 Jul 2024
- Primary completion15 Jan 2026 (estimated)
- Study completion15 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu Bo, Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06489119
- Sponsor's protocol ID
- KY2024-084
- Acronym
- MOOP-CAD
- Status last verified
- Sep 2025
- First submitted
- 17 Jun 2024
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-cell Multi-omics Analyses of OCT-diagnosed Plaque Subtypes in Coronary Artery Disease - a Prospective, Observational Study
- ClinicalTrials.gov ID
- NCT06489119
- Acronym / sponsor ID
- MOOP-CAD / KY2024-084
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary atherosclerosis, Optical coherence tomography, Multi-omics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Harbin Medical UniversityUniversity, hospital or other
- Study start
- 7 Jul 2024 (actual)
- Primary completion
- 15 Jan 2026 (estimated)
- Study completion
- 15 Jul 2026 (estimated)
- First posted
- 5 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (20 listed)
- Male or female, Age ≥ 18 years and ≤ 85 years.
- Ability to understand the requirements of the study and to provide informed consent.
- Patients with coronary angiographic diameter stenosis <20%.
- 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°.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
3 secondary outcomes
Incidence of SCD
Time frame: 1 year following hospital discharge
Incidence of nonfatal myocardial infarction
Time frame: 1 year following hospital discharge
Incidence of target vessel revascularization
Time frame: 1 year following hospital discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Harbin Medical University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bo Yu, MD,PhD (86-045186605180, yubodr@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of MACE (time frame: 1 year following hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.