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

Status: Recruiting
Location: See all (2) locations...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
China
China-Japan Union Hospital of Jilin
RECRUITING
Changchun
The Second Affiliated Hospital of Harbin Medical University
RECRUITING
Harbin
Contact Information
Primary
Bo Yu, MD,PhD
yubodr@163.com
86-045186605180
Backup
Maomao Zhang, MD,PhD
maomaolp1983@163.com
15145106466
Time Frame
Start Date: 2024-07-07
Estimated Completion Date: 2026-07-15
Participants
Target number of participants: 350
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Harbin Medical University

This content was sourced from clinicaltrials.gov