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.
Study Type
OBSERVATIONAL
Enrollment
4,500
Beijing An Zhen Hospital, Capital Medical University
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)
Time frame: 1 year
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.
Time frame: baseline
The incidence of procedural complications
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.
Time frame: 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.
Time frame: baseline
Major cardiovascular adverse events rate
The incidence of major adverse cardiovascular events (MACE) at 24 months and 36 months after index procedure.
Time frame: 2 and 3 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Beijing, Beijing Municipality, China
Peking Univerisity People'Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGBeijing Chao-Yang Hospital, Capital Medical University
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
NOT_YET_RECRUITINGGuangdong general hospital
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGThe first affiliated hospital of Guangxi medical university
Nanning, Guangxi, China
NOT_YET_RECRUITINGThe Second Affiliated Hospital of Hebei Meidical University
Shijiazhuang, Hebei, China
NOT_YET_RECRUITINGDaqing Oilfield General Hospital
Daqing, Heilongjiang, China
NOT_YET_RECRUITINGThe Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
RECRUITINGThe first affiliated hospital of Zhengzhou medical university
Zhengzhou, Henan, China
NOT_YET_RECRUITING...and 10 more locations