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| Name | Class |
|---|---|
| Abbott | INDUSTRY |
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The purpose of the study is to investigate the clinical outcomes, safety and cost-effectiveness of intravascular OCT imaging in patients with acute myocardial infarction undergoing percutaneous coronary intervention (PCI). About 4500 patients with acute myocardial infarction (estimated 1500 with OCT guidance and 3000 without OCT guidance during PCI）will be prospectively enrolled in 20 sites in China. The total duration of the study is expected to be 5 years, 2 years for enrolment and 3 years for follow up.
This is a prospective, multi-center, non-randomized, observational registry study of patients with acute myocardial infarction (AMI) that require catheterization. The purpose of this registry is to investigate the clinical outcomes, safety and cost-effectiveness of intravascular OCT imaging in patients with AMI undergoing PCI.The duration of the study is expected to be 5 years, 2 years for enrolment and 3 years for total follow up.The clinical study will be conducted in 20 centers in China.Approximately 4500 subjects (1500 with OCT imaging and 3000 without OCT imaging) will be enrolled in this study.Subjects will be followed up at 1, 3, 6, 12months and every 6 months afterwards up to 5 years. All subjects need to be followed for at least 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OCT group | 1500 AMI patients with OCT imaging guidance during PCI | ||
| CAG group | 3000 AMI patients without OCT imaging guidance during PPCI |
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| Measure | Description | Time Frame |
|---|---|---|
| Major cardiovascular adverse events rate | In patients treated conservatively, the safety objectives are to evaluate the occurrence of any adverse events in 1 year (re-infarction, re-hospitalization, revascularization by PCI or CABG, cardiac death, stoke, and major bleeding) | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of procedural strategy changes during the primary PCI | The rate of procedural strategy changes (thrombus aspiration or not, stenting or not, postdilation or not.) during the primary PCI. | baseline |
| The incidence of procedural complications |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with AMI who undergo primary PCI.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bo Yu, MD,PhD | Contact | +86045186605180 | yubodr@163.com | |
| Haibo Jia, MD,PhD | Contact | +8615945685291 |
| Name | Affiliation | Role |
|---|---|---|
| Bo Yu, MD,PhD | The Second Affiliated Hospital of Harbin Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing An Zhen Hospital, Capital Medical University | Not yet recruiting | Beijing | Beijing Municipality | 100029 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41477146 | Derived | Wang N, Xu YS, Feng X, Zeng M, Chen X, Yu B, Kou JJ. Stress hyperglycemia ratio and long-term prognosis in patients with acute myocardial infarction undergoing percutaneous coronary intervention: evidence for an J-shaped association. J Geriatr Cardiol. 2025 Dec 28;22(12):981-991. doi: 10.26599/1671-5411.2025.12.001. | |
| 32989612 | Derived |
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| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| D000072658 | Non-ST Elevated Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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The incidence of procedural complications including coronary artery dissection, acute occlusion, thrombosis, re-infarction, emergent coronary artery bypass graft, bleeding, no/slow reflow, and death.
| baseline |
| the indience of different plaque characteristic in the setting of STEMI | The incidence of plaque erosion, plaque rupture, calcified nodules, and other uncommon causes in the setting of STEMI. | baseline |
| Major cardiovascular adverse events rate | The incidence of major adverse cardiovascular events (MACE) at 24 months and 36 months after index procedure. | 2 and 3 year |
| Peking Univerisity People'Hospital | Not yet recruiting | Beijing | Beijing Municipality | 100044 | China |
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| Beijing Chao-Yang Hospital, Capital Medical University | Not yet recruiting | Beijing | Beijing Municipality | China |
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| The First Affiliated Hospital of Xiamen University | Not yet recruiting | Xiamen | Fujian | 361003 | China |
|
| Guangdong general hospital | Not yet recruiting | Guangzhou | Guangdong | China |
|
| The first affiliated hospital of Guangxi medical university | Not yet recruiting | Nanning | Guangxi | 530021 | China |
|
| The Second Affiliated Hospital of Hebei Meidical University | Not yet recruiting | Shijiazhuang | Hebei | China |
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| Daqing Oilfield General Hospital | Not yet recruiting | Daqing | Heilongjiang | 163001 | China |
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| The Second Affiliated Hospital of Harbin Medical University | Recruiting | Harbin | Heilongjiang | 150081 | China |
|
| The first affiliated hospital of Zhengzhou medical university | Not yet recruiting | Zhengzhou | Henan | China |
|
| Zhongda Hospital Southeast University | Not yet recruiting | Nanjing | Jiangsu | 210009 | China |
|
| The Second Affiliated Hospital of Nanchang University | Not yet recruiting | Nanchang | Jiangxi | 330006 | China |
|
| The first hospital of Jilin University | Not yet recruiting | Changchun | Jilin | 130000 | China |
|
| The Second Hospital of Jilin University | Not yet recruiting | Changchun | Jilin | 130000 | China |
|
| The third hospital of Jilin University | Not yet recruiting | Changchun | Jilin | 130000 | China |
|
| the second affiliated hospital of Dalian medical university | Not yet recruiting | Dalian | Liaoning | China |
|
| The First Affiliated Hospital of Xi'an Jiao Tong University | Not yet recruiting | Xian | Shanxi | 710061 | China |
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| The General Hospital of Tianjin Medical University | Not yet recruiting | Tianjin | Tianjin Municipality | China |
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| Tianjin Chest Hospital | Not yet recruiting | Tianjin | Tianjin Municipality | China |
|
| The First Affiliated Hospital of Xinjiang Medical University | Not yet recruiting | Ürümqi | Xinjiang | China |
|
| Wang J, Fang C, Zhang S, Li L, Lu J, Wang Y, Wang Y, Yu H, Wei G, Yin Y, Jiang S, Guo J, Lei F, Liu H, Xu M, Ren X, Ma L, Tu Y, Xing L, Hou J, Dai J, Yu B. Systemic and local factors associated with reduced thrombolysis in myocardial infarction flow in ST-segment elevation myocardial infarction patients with plaque erosion detected by intravascular optical coherence tomography. Int J Cardiovasc Imaging. 2021 Feb;37(2):399-409. doi: 10.1007/s10554-020-02021-1. Epub 2020 Sep 28. |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |