Clinical trial NCT03593928: Optical Coherence Tomography Examination in Acute Myocardial Infarction
Official title: Pre-intervention and Post-intervention Optical Coherence Tomography Examination for Culprit Lesion in Patients With ST-segment Elevation Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myocardial Infarction
Optical Coherence Tomography
Keywords: biomarker
plaque morphology
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2018-07-20
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients (age ≥18 years) who presented with STEMI and underwent emergent procedures were prospectively screened for OCT examination of the culprit lesion.

Brief summary: Different plaque morphology may have an important effect on the prognosis of acute myocardial infarction (AMI), as recent studies show that patients with plaque rupture have a significantly higher risk of cardiac events compared with those with plaque erosion. The primary purpose of this study is to find risk factors and biomarkers for different culprit lesion morphology to perform accurate risk stratification and determine an appropriate treatment strategy for patients with AMI.

Detailed description: Acute myocardial infarction (AMI), which results from coronary artery occlusion due to thrombosis, remains the leading cause of death and disability worldwide. Pathological studies have demonstrated that plaque rupture accompanied by subsequent thrombus formation is the main mechanism responsible for AMI, accounting for approximately two thirds of cases; the remaining approximately one third of cases are the result of plaque erosion. Moreover, previous studies showed that the risk of cardiovascular events is significantly higher in patients with plaque rupture compared to those with plaque erosion. The EROSION study suggested that in patients with acute coronary syndrome presenting with plaque erosion, conservative treatment with anti-thrombotic therapy may be a reasonable option instead of stents implantation. Therefore, it is important to differentiate between the culprit morphologies in order to perform an accurate risk stratification and determine a personalized treatment strategy with the goal to improve the prognosis of patients with AMI.

Optical coherence tomography (OCT), a newly developed high resolution near infrared light-based intravascular imaging modality, can visualize the microstructure of atherosclerotic plaques such as the fibrotic cap, lipid pool, thrombi, and so on, and has been considered as the golden standard for differentiating plaque morphology in vivo.

In this study, we aimed to find risk factors and biomarkers for culprit lesion morphology as assessed by OCT.

Eligibility criteria: Inclusion Criteria:

* Patients with ST-segment elevation myocardial infarction (defined as continuous chest pain lasted \>30 min, ST-segment elevation \>0.1 mV in at least two contiguous leads or new left bundle-branch block on the 18-lead electrocardiogram (ECG), and an elevated troponin I level)
* Age ≥18 years
* Provide written informed consent

Exclusion Criteria:

* Cardiac shock
* History of coronary artery bypass graft
* Left main diseases, extremely tortuous or heavily calcified vessels, or chronic total occlusion
* Inability to obtain Thrombolysis in myocardial infarction flow grade ≥ 2

Primary outcomes:
measure: culprit lesion morphology as assessed by OCT
timeFrame: 1 day (pre-intervention OCT examination of culprit lesion)
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese Academy of Medical Sciences, Fuwai Hospital
state: Beijing
Study officials:
affiliation: Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences
name: Hongbing Yan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhao X, Wang Y, Chen R, Li J, Zhou J, Liu C, Zhou P, Sheng Z, Chen Y, Song L, Zhao H, Yan H. Prognostic value of characteristics of plaque combined with residual syntax score among patients with STEMI undergoing primary PCI: an intravascular optical coherence tomography study. Thromb J. 2021 Nov 12;19(1):85. doi: 10.1186/s12959-021-00329-z.
citation: Wang Y, Zhao X, Zhou P, Liu C, Sheng Z, Li J, Zhou J, Chen R, Chen Y, Song L, Zhao H, Yan H. Plasma Pentraxin-3 Combined with Plaque Characteristics Predict Cardiovascular Risk in ST-Segment Elevated Myocardial Infarction: An Optical Coherence Tomography Study. J Inflamm Res. 2021 Sep 2;14:4409-4419. doi: 10.2147/JIR.S330600. eCollection 2021.
citation: Wang Y, Zhao X, Zhou P, Liu C, Sheng Z, Li J, Zhou J, Chen R, Chen Y, Song L, Zhao H, Yan H. Residual SYNTAX Score in Relation to Coronary Culprit Plaque Characteristics and Cardiovascular Risk in ST Segment Elevation Myocardial Infarction: an Intravascular Optical Coherence Tomography Study. J Cardiovasc Transl Res. 2022 Feb;15(1):75-83. doi: 10.1007/s12265-021-10152-6. Epub 2021 Jul 9.
citation: Zhou J, Chen R, Liu C, Zhou P, Li J, Wang Y, Zhao X, Zhao H, Song L, Yan H. Associations of NETs with inflammatory risk and atherosclerotic severity in ST-segment elevation myocardial infarction. Thromb Res. 2021 Jul;203:5-11. doi: 10.1016/j.thromres.2021.04.015. Epub 2021 Apr 19.
citation: Li J, Tan Y, Zhou P, Liu C, Zhao H, Song L, Zhou J, Chen R, Wang Y, Zhao X, Chen Y, Yan H. Association of Trimethylamine N-Oxide Levels and Calcification in Culprit Lesion Segments in Patients With ST-Segment-Elevation Myocardial Infarction Evaluated by Optical Coherence Tomography. Front Cardiovasc Med. 2021 Feb 24;8:628471. doi: 10.3389/fcvm.2021.628471. eCollection 2021.
citation: Zhou J, Yu S, Tan Y, Zhou P, Liu C, Sheng Z, Li J, Chen R, Zhao S, Yan H. Trimethylamine N-Oxide Was Not Associated With 30-Day Left Ventricular Systolic Dysfunction in Patients With a First Anterior ST-Segment Elevation Myocardial Infarction After Primary Revascularization: A Sub-analysis From an Optical Coherence Tomography Registry. Front Cardiovasc Med. 2020 Dec 23;7:613684. doi: 10.3389/fcvm.2020.613684. eCollection 2020.
citation: Zhou J, Sheng Z, Liu C, Zhou P, Li J, Chen R, Song L, Zhao H, Yan H. Association between Admission Hyperglycemia and Culprit Lesion Characteristics in Nondiabetic Patients with Acute Myocardial Infarction: An Intravascular Optical Coherence Tomography Study. J Diabetes Res. 2020 Jun 20;2020:1763567. doi: 10.1155/2020/1763567. eCollection 2020.
citation: Sheng Z, Zhou P, Liu C, Li J, Chen R, Zhou J, Song L, Zhao H, Yan H. Relationships of coronary culprit-plaque characteristics with duration of diabetes mellitus in acute myocardial infarction: an intravascular optical coherence tomography study. Cardiovasc Diabetol. 2019 Oct 19;18(1):136. doi: 10.1186/s12933-019-0944-8.
citation: Tan Y, Sheng Z, Zhou P, Liu C, Zhao H, Song L, Li J, Zhou J, Chen Y, Wang L, Qian H, Sun Z, Qiao S, Xu B, Gao R, Yan H. Plasma Trimethylamine N-Oxide as a Novel Biomarker for Plaque Rupture in Patients With ST-Segment-Elevation Myocardial Infarction. Circ Cardiovasc Interv. 2019 Jan;12(1):e007281. doi: 10.1161/CIRCINTERVENTIONS.118.007281.